CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 260 enrolled
Drug / intervention
ampicillin and metronidazole and gentamicin +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01994993
NCT01994993Phase 3Completed
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Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections (SCAMP Trial)

Michael Cohen-Wolkowiez·interventional·Posted Nov 26, 2013·Updated May 30, 2019

In Brief

A Phase 3 clinical trial evaluating ampicillin and metronidazole and gentamicin, ampicillin and gentamicin and clindamycin, and 3 other interventions for Complicated Intra Abdominal Infections. Completed, enrolled 260 participants across 50 sites in 2 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplicated Intra Abdominal Infections
CountriesCanada, United States
CollaboratorsThe Emmes Company, LLC

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 26, 2013
Enrollment StartDec 1, 2013
Primary CompletionJan 15, 2017
Study CompletionApr 20, 2017
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 12.6 years ago

Interventions

ampicillin and metronidazole and gentamicindrug

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 clindamycindrug

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- tazobactamdrug

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 metronidazoledrug

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-tazobactamdrug

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)