Data Sharing: Meropenem

Study Title

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

Study Description

This study evaluated the safety, tolerability and PK-PD of meropenem in infants <91 days of age with suspected and complicated intra-abdominal infections:

  1. To characterize meropenem single-dose and multiple-dose PK in participants 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.

For a full summary, see the meropenem study page.

Study Documents

Listed below are the key documents related to this study:

  1. Meropenem protocol
  2. Meropenem manual of procedures
  3. Meropenem annotated CRF
  4. Meropenem metadata report
  5. Meropenem CSR, Sections 1-16
  6. Meropenem article: PIDJ, 2011
  7. FDA docket
  8. ClinicalTrials.gov listing

Submitting a Request

If, upon review of these materials, you would like to submit a request for data, please complete the Data Sharing Request Form and send it to katherine.berezny@duke.edu.