NCT00621192

Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections

Multiple Dose Pharmacokinetic Study of Meropenem in Young Infants (<91 Days) With Suspected or Complicated Intra-abdominal Infections

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: The Emmes Company, LLC · Industry
• Sex: All
• Age: 90 Days
• Healthy volunteers: Not accepted

Summary

Meropenem is an antibiotic that is commonly used to treat serious infections. Although it is used in premature and young infants, the correct dose is not known. The purpose of this study is to determine the correct dose and the safety of meropenem for the treatment of complicated intra-abdominal infections in these young babies.

Detailed description

This study will evaluate the safety, tolerability and Pharmacokinetics - Pharmacodynamics (PK-PD) of meropenem in infants \<91 days of age with suspected and complicated intra-abdominal infections. The specific aims of this trial are: 1. To characterize meropenem single-dose and multiple-dose PK in subjects with suspected and complicated intra-abdominal infections. 2. To characterize the safety profile of meropenem in the treatment of suspected and complicated intra-abdominal infections. 3. To assess collected efficacy data for meropenem for the treatment of suspected and complicated intra-abdominal infections.

Conditions

• Necrotizing Enterocolitis
• Intra-abdominal Infection

Interventions

Type	Name	Description
DRUG	meropenem	Meropenem was administered concomitantly with compatible medications. Because an in-line filter is not appropriate due to drug binding, the 30 minute infusion was rate controlled by using appropriate infusion (syringe) pumps. Dosing and administration of other antimicrobial therapy (e.g., an aminoglycoside) was administered per local standard of care at the discretion of the infant's neonatologist. If there was a delay in the study drug shipment, sites were to use open-label meropenem to protect the safety of the participant. 20 mg/kg every 12 hours in infants \<32 weeks GA and PNA \< 2 weeks 20 mg/kg every 8 hours in infants \<32 weeks GA and PNA ≥ 2 weeks 20 mg/kg every 8 hours in infants ≥32 weeks GA and PNA \< 2 weeks 30 mg/kg every 8 hours in infants ≥32 weeks GA and PNA ≥ 2 weeks

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-02-22
• Last updated: 2023-04-25
• Results posted: 2011-11-29

Locations

26 sites across 1 country: United States