SCAMP-Antibiotic Safety in Infants with Complicated Intra-Abdominal Infections

Protocol Title: Antibiotic Safety in Infants with Complicated Intra-Abdominal Infections Primary Outcome: Safety of drug regimens (ampicillin, metronidazole, clindamycin, piperacillintazobactam, and gentamicin) Secondary Objectives: • Efficacy of drug regimens including ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, and gentamicin in infants with complicated intraabdominal infections • Pharmacokinetics (PK) of ampicillin, metronidazole, clindamycin, and piperacillin-tazobactam in infants with complicated intra-abdominal infections • Biomarker association with disease severity and antibiotic exposure • Association between genetic polymorphisms in CYP450 enzymes and metronidazole and clindamycin exposure • Comparison of intestinal microbiota between treatment arms • Cerebrospinal fluid (CSF) PK of metronidazole, clindamycin, and piperacillintazobactam in infants Study Design: Randomized, multicenter, open-label, safety study Study Population: Infants with complicated intra-abdominal infections (Groups 1-4) or those with suspected or confirmed infections (Group 5)