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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 (samples collected before the first imipenem/cilastatin/relebactam dose (i.e., blank), and at 0.5 and 6 hours following the first dose, and then at 0, 0.5, 0.75, 1, 2, 4, 5, and 6 hours after the start of the final dose).

Awards & highlights

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 hours (samples collected before the first imipenem/cilastatin/relebactam dose (i.e., blank), and at 0.5 and 6 hours following the first dose, and then at 0, 0.5, 0.75, 1, 2, 4, 5, and 6 hours after the start of the final dose).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 hours (samples collected before the first imipenem/cilastatin/relebactam dose (i.e., blank), and at 0.5 and 6 hours following the first dose, and then at 0, 0.5, 0.75, 1, 2, 4, 5, and 6 hours after the start of the final dose).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours (samples collected before the first imipenem/cilastatin/relebactam dose (i.e., blank), and at 0.5 and 6 hours following the first dose, and then at 0, 0.5, 0.75, 1, 2, 4, 5, and 6 hours after the start of the final dose). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Imipenem Clearance

Relebactam Clearance

Secondary study objectives

Imipenem Area Under the Curve (AUC)

Relebactam Area Under the Curve (AUC)

Side effects data

From 2023 Phase 1 trial • 8 Patients • NCT04493151

25%

Increasing Leukocytosis

13%

Aspartate Aminotransferase Increase

13%

Alkaline Phosphate Increase

13%

C. difficile Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

Imipenem-Cilastatin-Relebactam

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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