Conditions: Complicated Intra Abdominal Infections
Keywords: Antibiotics ampicillin metronidazole clindamycin piperacillin-tazobactam Safety Infants Intra abdominal infections
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 260
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Ampicillin and gentamycin and metronidazole arm 2: ampicillin and gentamicin and clindamycin arm 3: piperacillin-tazobactam and gentamicin arm 4: Per standard of care antibiotics, and Metronidazole arm 5: metronidazole, clindamycin, or piperacillin-tazobactam

Interventions: intervention 1: ampicillin and metronidazole and gentamicin intervention 2: ampicillin and gentamicin and clindamycin intervention 3: gentamicin and Piperacillin- tazobactam intervention 4: standard of care antibiotics and metronidazole intervention 5: metronidazole, clindamycin, or piperacillin-tazobactam
Intervention descriptions: intervention 1: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA) intervention 2: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA) intervention 3: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA) intervention 4: 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) intervention 5: 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)

Protocol document: