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Completed

NCT Number: NCT01994993

Antibiotic Safety (SCAMP)

The main purpose of this study is evaluate whether it is safe or not to use various combination of antibiotics (ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, gentamicin) in treating infants with complicated intra-abdominal infections

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Key information

Conditions

Complicated Intra Abdominal Infections Infections Intraabdominal Infections

Age range

Up to 120 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Alberta - Royal Alexandra Hospital, Edmonton, Alberta, Canada

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About this study

The most commonly used antibiotics in infants with complicated intra-abdominal infections are not labeled for use in this population because safety and efficacy data are lacking. This study will provide the safety information required for labeling. In addition, the pharmacokinetics(PK) and effectiveness data will also be collected during this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent obtained from parent(s) or legal guardian(s) (Groups 1-5)
  • ≤33 weeks gestation at birth (Groups 1-3, 5)
  • ≥34 weeks gestation at birth (Groups 4 and 5)
  • PNA <121 days (Groups 1-5)
  • Sufficient venous access to permit administration of study drug (intravenous [IV]) (Groups 1-5)
  • Presenting physical, radiological, and/or bacteriological findings of a complicated intra-abdominal infection within 48 hours prior to randomization/first study drug dose (Groups 1-4)**. Complicated intra-abdominal infections include secondary peritonitis, NEC grade II or higher by Bell's criteria, Hirschsprung's disease with perforation, spontaneous intestinal perforation, meconium ileus with perforation, bowel obstruction with perforation, gastroschisis with necrosis and/or perforation, omphalocele with necrosis and/or perforation, neonatal appendicitis, intestinal pneumatosis or portal venous gas, free peritoneal air on abdominal radiographic examination, or abdominal abscess.
  • Suspected or confirmed infection for which the study drug may provide therapeutic benefit and planned CSF collection per standard of care (Group 5).

Exclusion criteria

*

  • History of anaphylaxis in response to study drugs (Groups 1-5)
  • Serum creatinine >2 mg/dL within 48 hours on measurement prior to and closest to randomization /first study drug dose (Groups 1- 5)**
  • Known ALT >250 U/L or AST >500 U/L on measurement closest to the time of randomization or first study drug dose (Groups 1-5)**
  • Any condition that, in the judgment of the investigator, precludes participation because it could affect participant safety (Groups 1-5)
  • Do not apply for Group 5 participants receiving drug per standard of care
  • Criteria must be satisfied by randomization (randomized Groups 1-3) or first study drug dose (non-randomized Groups 1-3, Group 4 and Group 5), whichever comes first.

Treatment and study plan

ampicillin and metronidazole and gentamicin

Drug

IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

ampicillin and gentamicin and clindamycin

Drug

IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

gentamicin and Piperacillin- tazobactam

Drug

IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

standard of care antibiotics and metronidazole

Drug

IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

metronidazole, clindamycin, or piperacillin-tazobactam

Drug

IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Primary outcomes

  1. Death

    Time frame: Within 30 days after last dose of study drug, up to 40 days

    Number of Participants who experienced Death

Secondary outcomes

  1. Number of Participants With Therapeutic Success at Day 30

    Time frame: 30 days after last dose of study drug

    Confirmed by 1).Alive, 2).Negative bacterial blood cultures, and 3). Clinical cure score >4.

    Clinical cure score =1 for each of the following elements:

    FiO2 ≤ baseline FiO2; Urine output ≥1 mL/kg/h for 24-hour period prior to assessment; Absence of inotropic support at time of assessment; Absence of mechanical ventilation at time of assessment; No seizure in 24-hour period prior to assessment; pH ≥7.25 or not measured in 24 hours prior to assessment

Other outcomes

  1. Number of Participants With Feeding Intolerance

    Time frame: 90 days after last dose of study drug

    Feeding intolerance confirmed by documentation of any feedings held for >24 consecutive hours in infants being fed

  2. Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH)

    Time frame: 90 days after last dose of study drug

    Grade 3 IVH: Subependymal hemorrhage with extension into lateral ventricles with ventricular enlargement

    Grade 4 IVH: Intraparenchymal hemorrhage

  3. Number of Participants With Short Bowel Syndrome

    Time frame: 90 days after last dose of study drug

    Short bowel syndrome: Operative reports documenting resection of bowel, estimated bowel length, and absence/presence of the ileocecal valve.

    Total parenteral nutrition for >42 consecutive days after bowel resection, or a residual small bowel length of less than 25% expected for gestational age

  4. Number of Participants With Intestinal Perforation

    Time frame: 90 days after last dose of study drug

    Intestinal perforation: Radiological reports leading to the diagnosis of intestinal perforation. These include plain chest x-rays, plain abdominal x-rays, ultra-sonograms of the abdomen, contrast studies, and computed tomography scans of the abdomen and pelvis.

    Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal perforation. These include placement of a surgical drain, laparotomy, intestinal resection, and ostomy placement

  5. Number of Participants With Intestinal Stricture

    Time frame: 90 days after last dose of study drug

    Intestinal stricture: Radiology reports leading to the diagnosis of intestinal stricture. These include plain abdominal x-rays, upper gastrointestinal series with small bowel follow-through, contrast enema studies, and computed tomography scans of the abdomen and pelvis.

    Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal stricture. These procedures include endoscopy, laparotomy, stricture dilatation, intestinal resection, and ostomy placement

  6. Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC), if NEC is the Cause of the Complicated Intra-abdominal Infection

    Time frame: 90 days after last dose of study drug

    Progression is determined by the clinical NEC scoring

  7. Number of Participants With Gastrointestinal Surgeries

    Time frame: 90 days after last dose of study drug

    Determined by medical history and confirmed with hospital records. (Laparotomy)

  8. Number of Participants With Seizure

    Time frame: 90 days after last dose of study drug

    documented seizure(s) in hospital records

  9. Number of Participants With Positive Blood Cultures

    Time frame: 90 days after last dose of study drug

    Positive blood culture (bacterial or fungal)

Sponsors and collaborators

Lead sponsor

Michael Cohen-Wolkowiez

Other

Collaborators

  • The Emmes Company, LLC

Registry information

Official study title

Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections (SCAMP Trial)

Acronym: SCAMP

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 26, 2013
Registry last updated
May 30, 2019

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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