CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 8 enrolled
Drug / intervention
Imipenem, Cilastatin and Relebactamdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04493151
NCT04493151Phase 1Completed

Pharmacokinetics of Imipenem/Cilastatin/Relebactam in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)

Joseph L. Kuti, PharmD·interventional·Posted Jul 30, 2020·Updated Aug 7, 2024

In Brief

A Phase 1 clinical trial evaluating Imipenem, Cilastatin and Relebactam for Sepsis. Completed, enrolled 8 participants across 1 site.

Detailed Summary

Extracorporeal membrane oxygenation (ECMO) is a from of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and re-infused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, imipenem-cilastatin-relebactam, in critically ill patients receiving ECMO.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis
CountriesUnited States

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJul 30, 2020
Enrollment StartJan 1, 2021
Primary CompletionMay 31, 2023
Study CompletionJun 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.9 years ago

Interventions

Imipenem, Cilastatin and Relebactamdrug

After receipt of imipenem-cilastatin-relebactam, ten blood samples will be collected to determine the pharmacokinetics of imipenem and relebactam.