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OpenTrials
Completed

NCT Number: NCT02814916

Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA

To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus.

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Key information

Conditions

Methicillin-Resistant Staphylococcus Aureus Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Ninos Dr. Orlando Alassia /ID# 235562, Santa Fe, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients birth to 17 years (inclusive)
  • A clinical picture compatible with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) suspected or confirmed to be caused by Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA).
  • In addition to local signs of ABSSSI, the patient has at least one of the following:
  • Fever, defined as body temperature ≥ 38.4°C (101.2°F) taken orally, ≥ 38.7°C (101.6°F) tympanically, or ≥ 39°C (102.2°F) rectally (core temperature) OR
  • Leukocytosis (WBC > 10,000 mm3) or leukopenia (WBC < 2,000 mm3) or left shift of >10% band neutrophils
  • Infection either involving deeper soft tissue or requiring significant surgical intervention
  • Major cutaneous abscess characterized as a collection of pus within the dermis or deeper that is accompanied by erythema, edema and/or induration which i. requires surgical incision and drainage, and ii. is associated with cellulitis such that the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR iii. alternatively, involves the central face and is associated with an area of erythema of at least 15 cm2 b. Surgical site or traumatic wound infection characterized by purulent drainage with surrounding erythema, edema and/or induration which occurred within 30 days after the trauma or surgery and is associated with cellulitis such that: i. the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, involves the central face and is associated with an affected area of at least 15 cm2 c. Cellulitis, defined as a diffuse skin infection characterized by spreading areas of erythema, edema and/or induration and: i. is associated with erythema that involves at least 35 cm2 of surface area, or surface area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, cellulitis of the central face that is associated with an affected area of at least 15 cm2 5. In addition to the requirement for erythema, all patients are required to have at least two (2) of the following signs of ABSSSI: a. Purulent drainage/discharge b. Fluctuance c. Heat/localized warmth d. Tenderness to palpation e. Swelling/induration
  • In patients age birth to < 3 months, each patient must meet the following inclusion criteria to be enrolled in this study.
  • Male or female patients from birth to < 3 months of age, including pre-term neonates (gestational age ≥ 32 weeks)
  • A clinical picture compatible with an ABSSSI suspected or confirmed to be caused by Gram-positive bacteria, including MRSA.

OR

Suspected or confirmed sepsis including any of the following clinical criteria:

  • Hypothermia (<36°C) OR fever (>38.5°C)
  • Bradycardia OR tachycardia OR rhythm instability
  • Hypotension OR mottled skin OR impaired peripheral perfusion
  • Petechial rash
  • New onset or worsening of apnea episodes OR tachypnea episodes OR increased oxygen requirements OR requirement for ventilation support
  • Feeding intolerance OR poor sucking OR abdominal distension
  • Irritability
  • Lethargy
  • Hypotonia
  • In addition, patients must meet at least one of the following laboratory criteria:

a. White blood cell count ≤4.0 × 10^9/L OR ≥20.0 × 10^9/L b, Immature to total neutrophil ratio >0.2 c. Platelet count ≤100 × 10^9/L d. C-reactive protein (CRP) >15 mg/L OR procalcitonin ≥ 2 ng/mL e. Hyperglycemia OR Hypoglycemia f. Metabolic acidosis

  • Infections must be of sufficient severity to merit hospitalization and parenteral antibiotic therapy. These infections may include:
  • Cutaneous or subcutaneous abscess
  • Surgical site or traumatic wound infection
  • Cellulitis, Erysipelas
  • Omphalitis
  • Impetigo and bullous impetigo
  • Pustular folliculitis
  • Scarlet fever
  • Staphylococcal scalded skin syndrome
  • Streptococcal toxic shock syndrome
  • Erythematous based-erosion
  • Other infections originating in the skin or subcutaneous tissue and associated with signs and symptoms of sepsis as defined in Inclusion Criterion 2.
  • Patients must be expected to survive with appropriate antibiotic therapy and appropriate supportive care throughout the study.

Exclusion criteria

  • Patients age 3 months to 17 years: Clinically significant renal impairment, defined as calculated creatinine clearance of less than 30 mL/min. (calculated by the Schwartz "bedside" formula). Patients birth to < 3 months of age: Moderate or severe renal impairment defined as serum creatinine ≥ 2 times the upper limit of normal (× ULN) for age OR urine output < 0.5 mL/kg/h (measured over at least 8 hours prior to dosing) OR requirement for dialysis.
  • Clinically significant hepatic impairment, defined as serum bilirubin or alkaline phosphatase greater than 2 times the upper limits of normal (ULN) for age, and/or serum aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal (ULN) for age.
  • Treatment with an investigational drug within 30 days preceding the first dose of study medication.
  • Patients with sustained shock defined as systolic blood pressure < 90 mm Hg in children ≥ 10 years old, < 70 mm Hg + [2 x age in years] in children 1 to <10 years, or < 70 mmHg in infants 3 to <12 months old for more than 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure.
  • More than 24 hours of any systemic antibacterial therapy within 96 hours before randomization. EXCEPTION: Microbiological or clinical treatment failure with a systemic antibiotic other than IV study drug that was administered for at least 48 hours. Failure must be confirmed by either a microbiological laboratory report or documented worsening clinical signs or symptoms.
  • Infection due to an organism known prior to study entry to be resistant to dalbavancin (dalbavancin minimum inhibitory concentration (MIC) greater than 0.25 ug/mL) or vancomycin (vancomycin minimum inhibitory concentration (MIC) greater than 2 ug/mL).
  • Patients with necrotizing fasciitis, or deep-seated infections that would require > 2 weeks of antibiotics (e.g., endocarditis, osteomyelitis or septic arthritis).
  • Infections caused exclusively by Gram-negative bacteria (without Gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen.
  • Venous catheter entry site infection.
  • Infections involving diabetic foot ulceration, perirectal abscess or a decubitus ulcer.
  • Patient with an infected device, even if the device is removed. Examples include infection of: prosthetic cardiac valve, vascular graft, a pacemaker battery pack, joint prosthesis, implantable pacemaker or defibrillator, intraaortic balloon pump, left ventricular assist device, or a neurosurgical device such as a ventricular peritoneal shunt, intra-cranial pressure monitor, or epidural catheter.
  • Gram-negative bacteremia, even in the presence of Gram-positive infection or Gram-positive bacteremia. Note: If a Gram-negative bacteremia develops during the study, or is subsequently found to have been present at Baseline, the patient should be removed from study treatment and receive appropriate antibiotic(s) to treat the Gram-negative bacteremia.
  • Patients whose skin infection is the result of having sustained full or partial thickness burns.
  • Patients age 3 months to 17 years, with uncomplicated skin infections such as superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure. Patients birth to < 3 months of age may be enrolled if they have uncomplicated skin infections of sufficient severity to require hospitalization and parenteral antibiotic therapy.
  • Patients age 3 months to 17 years: Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study.
  • Sickle cell anemia
  • Cystic fibrosis
  • Anticipated need of antibiotic therapy for longer than 14 days.
  • Patients who are placed in a hyperbaric chamber as adjunctive therapy for the ABSSSI.
  • More than 2 surgical interventions (defined as procedures conducted under sterile technique and typically unable to be performed at the bedside) for the skin infection, or patients who are expected to require more than 2 such interventions.
  • Medical conditions in which chronic inflammation may preclude assessment of clinical response to therapy even after successful treatment (e.g., chronic stasis dermatitis of the lower extremity).
  • Immunosuppression/immune deficiency, including hematologic malignancy, recent bone marrow transplant (in post-transplant hospital stay), absolute neutrophil count < 500 cells/mm3, receiving immunosuppressant drugs after organ transplantation, receiving oral steroids ≥ 20 mg prednisolone per day (or equivalent) for > 14 days prior to enrollment, and known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 cell count< 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count.
  • Known or suspected hypersensitivity to glycopeptide antibiotics, betalactam agents, aztreonam, or cephalosporins.
  • Patients with a rapidly fatal illness, who are not expected to survive for 3 months.
  • Positive urine (or serum) pregnancy test at screening (post-menarchal females only) or after admission (prior to dosing).
  • Pregnant or nursing females; sexually active females of childbearing potential who are unwilling or unable to use adequate contraceptive precautions. Female patients to have pregnancy testing are those who are at least 10 years old with menarche and/or thelarche (beginning of breast development).

Treatment and study plan

Dalbavancin

Drug

Dalbavancin was administered intravenously over 30 (± 5) minutes.

Other names: Xydalba

Vancomycin

Drug

Vancomycin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.

Oxacillin

Drug

Oxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.

Flucloxacillin

Drug

Flucloxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.

Cefadroxil

Drug

Cefadroxil was administered orally every 12 hours.

Clindamycin

Drug

Clindamycin was administered orally every 8 hours.

Primary outcomes

  1. Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit

    Time frame: Baseline, Day 28 (± 2 days)

    Audiologic testing was to be conducted in at least 20 children < 12 years old, of which at least 9 children were < 2 years old. Audiologic testing conducted on infants (< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.

  2. Shift From Baseline in Auditory Brainstem Response Test at TOC Visit

    Time frame: Baseline, Day 28 (± 2 days)

    Audiologic testing was to be conducted in at least 20 children < 12 years old, of which at least 9 children were < 2 years old. Audiologic testing conducted on infants (< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.

  3. Shift From Baseline in Acoustic Immittance Test at TOC Visit

    Time frame: Baseline, Day 28 (± 2 days)

    Audiologic testing was to be conducted in at least 20 children < 12 years old, of which at least 9 children were < 2 years old. Audiologic testing conducted on infants (< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.

  4. Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit

    Time frame: Baseline, Day 28 (± 2 days)

    Audiologic testing was to be conducted in at least 20 children < 12 years old, of which at least 9 children were < 2 years old. Audiologic testing conducted on infants (< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.

  5. Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit

    Time frame: Baseline, Day 28 (± 2 days)

    Bowel flora was evaluated in participants from birth to < 2 years of age by performing polymerase chain reaction (PCR) analysis for Clostridium difficile (C diff) and culture for vancomycin-resistant enterococci (VRE) on a stool specimen or rectal swab. Samples were analyzed at Baseline and at the Test of Cure (TOC) visit.

Secondary outcomes

  1. Clinical Response at 48-72 Hours

    Time frame: Baseline, 48-72 hours

    Clinical response defined as ≥20% reduction in lesion size compared to Baseline in Cohorts 1-4; cessation of increase in lesion size and decreased erythema or tenderness compared to Baseline with no appearance of new lesions in those with ABSSSI in Cohort 5; and improvement of at least one abnormal clinical and laboratory parameter related to sepsis in those diagnosed with sepsis in Cohort 5. To be considered a clinical responder, participants must have been alive and not have received rescue therapy.

    Presented for the modified intent-to-treat (mITT) population: all participants who received at least one dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.

  2. Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)

    Time frame: Baseline, Day 14 (± 2 Days)

    Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study.

    Improvement: For Cohorts 1-4 and Cohort 5 with ABSSSI, reduction in severity of ≥2, but not all CSSI, when compared with Baseline. For Cohort 5 with sepsis, reduction in severity of ≥1 abnormal clinical and laboratory parameter related to sepsis, when compared with Baseline. For Cohorts 1-4, no additional antibacterial Tx required for disease under study. For Cohort 5, no rescue antibiotics required after ≥48 hours of start of study Tx.

    Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection.

    Unknown: Extenuating circumstances precluding classification to Cure, Improvement, or Failure.

    Presented for the modified intent-to-treat (mITT) population.

  3. Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)

    Time frame: Baseline, Day 14 (± 2 Days)

    Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment.

    Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.

  4. Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)

    Time frame: Baseline, Day 28 (± 2 Days)

    Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study.

    Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection.

    Unknown: Extenuating circumstances precluding classification to Cure or Failure.

    Presented for the modified intent-to-treat (mITT) population.

  5. Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)

    Time frame: Baseline, Day 28 (± 2 Days)

    Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment.

    Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.

  6. Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome)

    Time frame: Baseline, Day 54 (± 7 days)

    Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study.

    Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection.

    Unknown: Extenuating circumstances precluding classification to Cure or Failure.

    Presented for the modified intent-to-treat (mITT) population

  7. Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor)

    Time frame: Baseline, Day 54 (± 7 days)

    Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment.

    Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.

  8. Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)

    Time frame: Baseline, 48-72 hours

    Clinical response defined as ≥20% reduction in lesion size compared to Baseline in Cohorts 1-4; cessation of increase in lesion size and decreased erythema or tenderness compared to Baseline with no appearance of new lesions in those with ABSSSI in Cohort 5; and improvement of at least one abnormal clinical and laboratory parameter related to sepsis in those diagnosed with sepsis in Cohort 5. To be considered a clinical responder, participants must have been alive and not have received rescue therapy.

    Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.

  9. Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)

    Time frame: Baseline, Day 14 (± 2 Days)

    Cure: Resolution of clinical signs/symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study.

    Improvement: Cohorts 1-4 and Cohort 5 with ABSSSI: reduction in severity of ≥2, but not all CSSI, when compared to Baseline. Cohort 5 with sepsis: reduction in severity of ≥1 abnormal clinical/laboratory parameter related to sepsis, when compared to Baseline. Cohorts 1-4: no additional antibacterial Tx required for disease under study. Cohort 5: no rescue antibiotics required after ≥48 hrs of start of study Tx.

    Failure: Persistence/progression of Baseline CSSI after 48 hrs of Tx OR development of new findings consistent with active infection.

    Unknown: Extenuating circumstances precluding classification to Cure, Improvement, or Failure.

    Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.

  10. Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)

    Time frame: Baseline, Day 14 (± 2 Days)

    Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment.

    Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.

  11. Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)

    Time frame: Baseline, Day 28 (± 2 Days)

    Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study.

    Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection.

    Unknown: Extenuating circumstances precluding classification to Cure or Failure.

    Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.

  12. Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)

    Time frame: Baseline, Day 28 (± 2 Days)

    Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment.

    Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.

  13. Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)

    Time frame: Baseline, Day 54 (± 7 days)

    Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study.

    Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection.

    Unknown: Extenuating circumstances precluding classification to Cure or Failure.

    Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.

  14. Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)

    Time frame: Baseline, Day 54 (± 7 days)

    Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment.

    Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.

  15. Microbiological Response at 48-72 Hours

    Time frame: Baseline, 48-72 hours

    Eradication: Source specimen demonstrated absence of the original Baseline pathogen.

    Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical responder.

    Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen.

    Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical non-responder.

    Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing.

    Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.

  16. Microbiological Response at the End of Treatment (EOT) Visit

    Time frame: Baseline, Day 14 (± 2 Days)

    Eradication: Source specimen demonstrated absence of the original Baseline pathogen.

    Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure or improvement.

    Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen.

    Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure.

    Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing.

    Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.

  17. Microbiological Response at the Test of Cure (TOC) Visit

    Time frame: Baseline, Day 28 (± 2 Days)

    Eradication: Source specimen demonstrated absence of the original Baseline pathogen.

    Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure.

    Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen.

    Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure.

    Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing.

    Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.

  18. Microbiological Response at the Follow-Up Visit

    Time frame: Baseline, Day 54 (± 7 days)

    Eradication: Source specimen demonstrated absence of the original Baseline pathogen.

    Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure.

    Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen.

    Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure.

    Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing.

    Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.

  19. Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen

    Time frame: Baseline, 48-72 hours

    Eradication: Source specimen demonstrated absence of the original Baseline pathogen.

    Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical responder.

    Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen.

    Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical non-responder.

    Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing.,

    Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.

  20. Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen

    Time frame: Baseline, Day 14 (± 2 Days)

    Eradication: Source specimen demonstrated absence of the original Baseline pathogen.

    Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure or improvement.

    Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen.

    Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure.

    Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing.

    Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.

  21. Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen

    Time frame: Baseline, Day 28 (± 2 Days)

    Eradication: Source specimen demonstrated absence of the original Baseline pathogen.

    Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure.

    Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen.

    Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure.

    Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing.

    Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.

  22. Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen

    Time frame: Baseline, Day 54 (± 7 days)

    Eradication: Source specimen demonstrated absence of the original Baseline pathogen.

    Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure.

    Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen.

    Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure.

    Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing.

    Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.

  23. All-cause Mortality at the Test of Cure (TOC) Visit Among Cohort 5 Participants

    Time frame: Day 28 (± 2 Days)

    All-cause mortality was determined for the participants in Cohort 5 (birth to < 3 months) at the Test of Cure visit.

  24. Concentration of Dalbavancin in Plasma

    Time frame: 30 min (end of infusion on Day 1); 2 hrs after start of IV (Day 1); and 48-72 hrs, 168 hrs, and 312 hrs after start of IV

    The population pharmacokinetic (PK) profile of dalbavancin was assessed using a sparse sampling approach. Plasma PK samples were collected from participants receiving dalbavancin treatment (single-dose and two-dose arms) at 30 minutes and at 2 hours (Day 1), at 48-72 hours (Day 3-4), at 168 ± 24 hours (Day 8 ± 1), and at 312 ± 48 hours and analyzed for dalbavancin concentration.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jun 28, 2016
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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