NCT01994993

Antibiotic Safety (SCAMP)

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Michael Cohen-Wolkowiez · Academic / Other
• Sex: All
• Age: 120 Days
• Healthy volunteers: Not accepted

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

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.

Conditions

• Complicated Intra Abdominal Infections

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-01-15
• Completion: 2017-04-20
• First posted: 2013-11-26
• Last updated: 2019-05-30
• Results posted: 2018-02-27

Locations

50 sites across 2 countries: United States, Canada