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Antibiotic Safety (SCAMP)

NCT01994993 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2019-05-30

Study results available
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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

Conditions

  • Complicated Intra Abdominal Infections

Interventions

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)

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)

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)

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)

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)

Sponsors & Collaborators

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • Michael Cohen-Wolkowiez

    lead OTHER

Principal Investigators

  • Micheal Cohen-Wolkowiez, MD, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
120 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-01-15
Completion
2017-04-20

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01994993 on ClinicalTrials.gov