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Completed

NCT Number: NCT01593761

Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus

Primary Objective:

To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with cABSSSI (major cutaneous abscesses) due to MRSA.

Secondary Objective(s):

* To assess the pharmacokinetics of CG400549 (960 mg daily) in subjects with cABSSSI due to MRSA * To explore the in vitro susceptibility of cABSSSI-related bacteria to CG400549. * To assess the safety of multiple doses of CG400459

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Key information

Conditions

Skin Infection Cellulitis Connective Tissue Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

eStudysite

La Mesa, California, 91942, United States

About this study

This will be an open-label, exploratory study to evaluate the safety, pharmacokinetics, and efficacy of CG400549, daily for 10 to 14 days, in subjects with cABSSSI (major cutaneous abscesses) due to MRSA. All subjects will receive active treatment.

Subjects will begin study treatment upon confirmation of clinical eligibility (ie, confirmation of MRSA infection is not required pretreatment). Subjects who begin treatment with CG400549 and are subsequently not found to have S. aureus infection will be discontinued from study treatment, treated as appropriate for the identified pathogen(s), and followed for safety. These subjects will be included in the safety analyses but not in the primary efficacy analysis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of major cutaneous abscess suspected or confirmed to be caused by a MRSA.
  • Signs and symptoms should include at least 2 of the following: purulent drainage or discharge, erythema, fluctuance, heat or localized warmth, edema/induration, pain or tenderness to palpation

Exclusion criteria

  • Prior systemic or topical antibacterial therapy
  • Severe sepsis or refractory shock

Treatment and study plan

CG400549

Drug

960mg QD at fed state approx 1 hour after meal

Primary outcomes

  1. Status of Subject's Clinical Responses

    Time frame: Early Clinical Evaluation (ECE, 48 to 72 hours after enrollment)

    Stable/improving infection, as defined by the Investigator assessment, was defined as cessation of the spread of the redness, edema, and/or induration of the lesion or reduction in the size (length, width, and shortest distance from the peripheral margin of the abscess) of redness, edema, and/or induration and absence of fever (< 37.7 °C)

Secondary outcomes

  1. Status of Subject's Clinical Response

    Time frame: End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)

    • Clinical cure was defined as absence of fever (< 37.7°C); presence of granulation or wound healing; resolution of pain; and decreased or resolved erythema, edema,induration, and color. Ulceration could persist, but lesions had to appear non-infected to be defined as clinical cure.
    • Clinical improvement was defined as moderate resolution of 2 or more clinical symptoms.
    • clinical failure was defined as persistence or progression of baseline signs and symptoms of cABSSSI, development of new signs and symptoms consistent with Gram-positive infection, or inability to complete the study because of AEs

  2. Status of Subject's Microbial Eradication Response

    Time frame: End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)

    • Microbial eradication was defined by culture (complete absence of all infecting organisms identified at baseline) or presumed because of an absence of clinical symptoms.
    • Microbiological Persistence was defined as the presence of one or more of the original infecting organisms on the TOC culture or as the absence of cultures in case of clinical failure.
    • Microbiological Recurrence was defined as the presence on the final culture of an original infecting organism whose eradication had been either documented or presumed a the end of therapy.

  3. Overall Summary of Adverse Events

    Time frame: From time of signing the informed consent to Test of Cure (TOC, 21-28 days after after beginning treatment)

    Treatment-Emergent Adverse Event (TEAE) are those that

    • Emerging during treatment, having been absent pre-treatment or
    • Reemerge during treatment, having been present at baseline but stopped prior to treatment or
    • Worsen in severity during treatment relative to the pre-treatment state, when the adverse event is continuous.

  4. Mean Plasma Concentration-time Profile of CG400549

    Time frame: Day 1 predose, Day 1 1hour, Day 1 2hour, Day 1 4hour

    The concentrations of CG400549 in plasma collected at each point were analyzed and calculated for its mean plasma concentration.

Sponsors and collaborators

Lead sponsor

CrystalGenomics, Inc.

Industry

Registry information

Official study title

Phase 2a, Repeated-dose, Open-label, Single-arm Study of CG400549 for the Treatment of Complicated Acute Bacterial Skin and Skin Structure Infection (cABSSSI) Caused by Methicillin-resistant Staphylococcus Aureus (MRSA)

Acronym: CG400549

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 8, 2012
Registry last updated
Sep 10, 2022

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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