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Carbapenem

Imipenem-Relebactam for Blood Cancer-Related Infections

Phase 2

Waitlist Available

Led By Issam I Raad

Research Sponsored by M.D. Anderson Cancer Center

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 within 72 hours after administration of the last dose of inpatient iv study drug.

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying imipenem-relebactam to compare it with standard-of-care treatments for febrile neutropenia.

Who is the study for?

This trial is for adults over 18 with cancer and low white blood cell counts causing fever (febrile neutropenia), who need hospitalization for IV antibiotics. They must be able to follow the study plan, not pregnant or breastfeeding, and willing to use effective contraception if of childbearing potential. Excluded are those allergic to certain antibiotics, with severe liver or kidney issues, HIV positive, on recent IV antibiotic treatment other than prophylaxis, or have a life expectancy under 3 months.

What is being tested?

The trial tests imipenem-relebactam against standard treatments like cefepime and meropenem in patients with febrile neutropenia due to cancer. It aims to see if imipenem-relebactam can better control this condition that requires hospital-based IV antibiotic therapy.

What are the potential side effects?

Possible side effects include allergic reactions similar to penicillin allergies such as rashes and anaphylaxis; gastrointestinal symptoms like nausea, vomiting, diarrhea; potential liver enzyme elevations; and central nervous system effects such as seizures in individuals predisposed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 72 hours after administration of the last dose of inpatient iv study drug.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 72 hours after administration of the last dose of inpatient iv study drug.

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 72 hours after administration of the last dose of inpatient iv study drug. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Clinical Outcome in the MITT Analysis Set at EOIV.

Secondary study objectives

30-Day All-cause Mortality in the MITT Analysis Set.

30-Day All-cause Mortality in the mMITT Analysis Set.

Clinical Outcome in the CE Analysis Set at EOIV.

+20 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (imipenem, cilastatin, relebactam)Experimental Treatment4 Interventions

Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes q6h for 2 days for a minimum of 8 doses. Patients may also receive gram-positive therapy at the discretion of the primary team or emergency center physician consisting of vancomycin IV q12h or linezolid IV or PO q12h. Patients may continue to receive imipenem/cilastatin/relebactam IVover 30-60 minutes for up to 14 days if clinically indicated by the assessment of the treating physician.

Group II: Group II (cefepime, meropenem, piperacillin/tazobactam)Active Control6 Interventions

Patients receive cefepime IV q8h for a minimum of 6 doses, meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. Patients may also receive gram-positive therapy at the discretion of the primary team or emergency center physician consisting of vancomycin IV q12h or linezolid IV or PO q12h.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Imipenem/Cilastatin/Relebactam

2021

Completed Phase 2

~100

Vancomycin

2020

Completed Phase 4

~7920