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Antibiotic Safety (SCAMP) (SCAMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01994993
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : February 27, 2018
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
The Emmes Company, LLC
Information provided by (Responsible Party):
Michael Cohen-Wolkowiez, Duke University

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Complicated Intra Abdominal Infections Drug: ampicillin and metronidazole and gentamicin Drug: ampicillin and gentamicin and clindamycin Drug: gentamicin and Piperacillin- tazobactam Drug: standard of care antibiotics and metronidazole Drug: metronidazole, clindamycin, or piperacillin-tazobactam Phase 2 Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections (SCAMP Trial)
Study Start Date : December 2013
Actual Primary Completion Date : January 15, 2017
Actual Study Completion Date : April 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1 (ampicillin +gentamycin +metronidazole)
Ampicillin and gentamycin and metronidazole
 Drug: ampicillin and metronidazole and gentamicin
IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
Active Comparator: Group 2 (ampicillin +gentamicin+clindamycin)
ampicillin and gentamicin and clindamycin
 Drug: ampicillin and gentamicin and clindamycin
IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
Active Comparator: Group 3 (piperacillin-tazobactam and gentamicin)
piperacillin-tazobactam and gentamicin
 Drug: gentamicin and Piperacillin- tazobactam
IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
Active Comparator: Group 4 (metronidazole)
Per standard of care antibiotics, and Metronidazole
 Drug: standard of care antibiotics and metronidazole
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)
Active Comparator: Group 5 (metronidazole/clindamycin/piperacillin-tazobactam)
metronidazole, clindamycin, or piperacillin-tazobactam
 Drug: metronidazole, clindamycin, or piperacillin-tazobactam
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)


Outcome Measures
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Primary Outcome Measures :
  1. Death [ Time Frame: Within 30 days after last dose of study drug, up to 40 days ]
    Number of Participants who experienced Death


Secondary Outcome Measures :
  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 Outcome Measures:
  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)


Eligibility Criteria
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Ages Eligible for Study:   up to 120 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent obtained from parent(s) or legal guardian(s) (Groups 1-5)
  2. ≤33 weeks gestation at birth (Groups 1-3, 5)
  3. ≥34 weeks gestation at birth (Groups 4 and 5)
  4. PNA <121 days (Groups 1-5)
  5. Sufficient venous access to permit administration of study drug (intravenous [IV]) (Groups 1-5)
  6. 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.
  7. 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*

  1. History of anaphylaxis in response to study drugs (Groups 1-5)
  2. Serum creatinine >2 mg/dL within 48 hours on measurement prior to and closest to randomization /first study drug dose (Groups 1- 5)**
  3. 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)**

  4. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994993


Locations
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Sponsors and Collaborators
Michael Cohen-Wolkowiez
The Emmes Company, LLC
Investigators
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Principal Investigator: Micheal Cohen-Wolkowiez, MD, PhD Duke University
More Information
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Responsible Party: Michael Cohen-Wolkowiez, Associate Professor, Duke University
ClinicalTrials.gov Identifier: NCT01994993    
Other Study ID Numbers: Pro00048773
HHSN275201000003I ( Other Grant/Funding Number: NICHD )
First Posted: November 26, 2013    Key Record Dates
Results First Posted: February 27, 2018
Last Update Posted: May 30, 2019
Last Verified: May 2019
Keywords provided by Michael Cohen-Wolkowiez, Duke University:
Antibiotics
ampicillin
metronidazole
clindamycin
 piperacillin-tazobactam
Safety
Infants
Intra abdominal infections
Additional relevant MeSH terms:
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Infection
Intraabdominal Infections
Anti-Bacterial Agents
Metronidazole
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Gentamicins
Tazobactam
Piperacillin
Ampicillin
 Piperacillin, Tazobactam Drug Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors