Research

Meropenem Antibiotic Study

Multiple Dose Pharmacokinetic Study of Meropenem in Young Infants with Suspected or Complicated Intra-abdominal Infections

Protocol Description

The purpose of this Phase II multi-center study is to determine pharmacokinetics and safety of the drug meropenem when used for suspected and complicated intra-abdominal infections, such as nectrotizing enterocolitis or peritonitis, in infants younger than three months of age. Pharmacokinetic studies determine how much of the study drug enters the blood and how fast the study drug is broken down and removed from the blood. These studies will help to determine the correct dosage of meropenem needed in babies less than 91 days of life.

Eligibility Criteria

Subject to certain exclusion criteria, infants who are less than 91 days old who are hospitalized in the Neonatal Intensive Care Unit (NICU) of Children’s Hospital of Pittsburgh of UPMC or Magee-Womens Hospital of UPMC for treatment of a complicated intra-abdominal infection will be considered eligible for participation.
Boys: Less than 91 days old
Girls: Less than 91 days old

Requirements
Enrolled infants will receive meropenem in one of 3 dosage regimens (low, medium or high), in addition to other antibiotics recommended to treat the illness. A physical exam and a review of the infant’s past and present medical history will be conducted. All infants will receive meropenem for at least 3 days and no more than 21 days, as determined by the baby’s doctor, and blood testing will be done to monitor levels of meropenem.
Visits: Requires hospitalization
Duration: Infants will receive study medication for 3-21 days and then will be monitored for 30 days after the last dose of study medication.

Status: Closed to Enrollment

Source (s) of Support
National Institute of Child Health and Human Development

Additional Resources
Study description at National Institutes of Health