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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
Study 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.Check my eligibility
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.See study design
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Outcome in the MITT Analysis Set at EOIV.
Secondary outcome measures
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 moreTrial 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
2005
Completed Phase 4
~7930
Daptomycin
2006
Completed Phase 4
~2940
Linezolid
2002
Completed Phase 4
~4470
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,116 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,874 Total Patients Enrolled
Issam I RaadPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an allergic reaction to certain types of antibiotics called cephalosporins or carbapenems.You have a fever that is not caused by an infection or illness, such as a reaction to medication or blood transfusion.You need to undergo hemodialysis while receiving the study treatment.You are already participating in another study with the drug imipenem-relebactam.You have a history of epilepsy or seizures, except if you had a well-documented seizure as a child due to a fever.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (imipenem, cilastatin, relebactam)
- Group 2: Group II (cefepime, meropenem, piperacillin/tazobactam)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have enrolled in this medical study?
"Affirmative. Per clinicaltrials.gov, the trial which went live on September 14th 2021 is still recruiting participants with a goal of 100 volunteers at 1 site. The information was most recently updated October 6th 2022."
Answered by AI
For which conditions is Imipenem/cilastatin-relebactam typically prescribed?
"Imipenem/cilastatin-relebactam is the preferred treatment for complex skin and subcutaneous tissue infections caused by streptococcus agalactiae. In addition, this medication can be beneficial in combatting pneumonia, postoperative infection, and community acquired pneumonia (CAP)."
Answered by AI
Could you provide a synopsis of previous research on Imipenem/cilastatin-relebactam?
"Currently, there are 98 active trials assessing the efficacy of Imipenem/cilastatin-relebactam with 19 in Phase 3. Despite being primarily located in Cincinnati, Ohio, this research is available at 944 different clinical sites worldwide."
Answered by AI
Are healthcare professionals still enrolling participants in this research?
"That is correct. According to clinicaltrials.gov, this medical trial is currently recruiting patients and has been since it was first posted on September 14th 2021. The study requires 100 participants from a single centre for participation."
Answered by AI
What potential risks are associated with Imipenem/cilastatin-relebactam administration?
"The safety rating for Imipenem/cilastatin-relebactam is 2, indicating that while there are some clinical data points supporting its safety profile, no information exists to support efficacy."
Answered by AI
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