Multiple Dose Pharmacokinetic Study of Meropenem in Young Infants (<91 days) with Suspected or Complicated Intra-abdominal Infections
This study evaluated the safety, tolerability and PK-PD of meropenem in infants <91 days of age with suspected and complicated intra-abdominal infections:
- To characterize meropenem single-dose and multiple-dose PK in participants with suspected and complicated intra-abdominal infections.
- To characterize the safety profile of meropenem in the treatment of suspected and complicated intra-abdominal infections.
- To assess collected efficacy data for meropenem for the treatment of suspected and complicated intra-abdominal infections.
For a full summary, see the meropenem study page.
Listed below are the key documents related to this study:
- Meropenem protocol
- Meropenem manual of procedures
- Meropenem annotated CRF
- Meropenem metadata report
- Meropenem CSR, Sections 1-16
- Meropenem article: PIDJ, 2011
- FDA docket
- ClinicalTrials.gov listing