Antibiotic Safety (SCAMP)

NCT01994993 ↗

Phase 2/3 Completed 260 enrolled Michael Cohen-Wolkowiez The Emmes Company, LLC · collab

RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start: 2013-12
Primary completion: 2017-01-15
Completion: 2017-04-20

Publications

Smith MJ, Boutzoukas A, Autmizguine J, Hudak ML, Zinkhan E, Bloom BT, Heresi G, Lavery AP, Courtney SE, Sokol GM, Cotten CM, Bliss JM, Mendley S, Bendel C, Dammann CEL, Weitkamp JH, Saxonhouse MA, Mundakel GT, Debski J, Sharma G, Erinjeri J, Gao J, Benjamin DK Jr, Hornik CP, Smith PB, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections. Pediatr Infect Dis J. 2021 Jun 1;40(6):550-555. doi: 10.1097/INF.0000000000003034.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Amoxicillin	Other / unclassified	—	Intravenous
Comparator	Ampicillin	Unknown	—	Intravenous
Comparator	Clindamycin	Unknown	—	Intravenous
Comparator	Gentamicin	Small molecule	—	Intravenous
Comparator	Metronidazole	Small molecule	—	Intravenous

Indications

No indication recorded.