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Dehydropeptidase inhibitor

Imipenem, Cilastatin and Relebactam for Sepsis

Phase 1
Waitlist Available
Led By Joseph L Kuti, PharmD
Research Sponsored by Joseph L. Kuti, PharmD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours
Awards & highlights

Study Summary

This trial is designed to assess how well a new broad-spectrum antibiotic, imipenem-cilastatin-relebactam, works in critically ill patients receiving ECMO.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Imipenem Clearance
Relebactam Clearance
Secondary outcome measures
Imipenem Area Under the Curve (AUC)
Relebactam Area Under the Curve (AUC)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Imipenem-Cilastatin-RelebactamExperimental Treatment1 Intervention
Participants will receive a four to six doses of intravenous imipenem-cilastatin-relebactam as per current prescribing information based on estimated creatinine clearance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imipenem, Cilastatin and Relebactam
2021
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Joseph L. Kuti, PharmDLead Sponsor
3 Previous Clinical Trials
47 Total Patients Enrolled
1 Trials studying Sepsis
8 Patients Enrolled for Sepsis
Merck Sharp & Dohme LLCIndustry Sponsor
3,890 Previous Clinical Trials
5,060,293 Total Patients Enrolled
7 Trials studying Sepsis
1,705 Patients Enrolled for Sepsis
Joseph L Kuti, PharmDPrincipal InvestigatorHartford Hospital
4 Previous Clinical Trials
59 Total Patients Enrolled
1 Trials studying Sepsis
8 Patients Enrolled for Sepsis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Imipenem/Cilastatin/Relebactam PK in ECMO
Joseph L. Kuti, PharmD 2021. "Imipenem/Cilastatin/Relebactam PK in ECMO". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04493151.
~2 spots leftby Apr 2025
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