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IMI/REL for Bacterial Infections
Phase 2 & 3
Recruiting
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Requires hospitalization and treatment with IV antibacterial therapy for confirmed or suspected gram-negative bacterial infection (in the absence of meningitis), and is expected to require hospitalization through completion of IV study intervention, with at least 1 of the following primary infection types: HABP or VABP; cIAI; or cUTI.
Has sufficient intravascular access to receive study drug through an existing peripheral or central line.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on day 1 at 30 minutes prior to start of first iv infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (day 2 or day 3) at 2 to 6 hours after start of any infusion that day.
Awards & highlights
Study Summary
This trial is studying the safety and effectiveness of a new drug, imipenem/cilastatin/relebactam, in children up to 18 years old who have a confirmed or suspected bacterial infection.
Who is the study for?
This trial is for children and adolescents from birth to under 18 years with suspected or confirmed gram-negative bacterial infections requiring hospitalization. They must not have conditions like meningitis, endocarditis, or certain urinary tract complications. Females of childbearing potential must follow contraceptive guidance.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a drug combination called IMI/REL compared to an active control in treating serious bacterial infections. Participants are randomly assigned to receive either treatment, with a focus on survival rates and response to therapy.See study design
What are the potential side effects?
Possible side effects may include allergic reactions, digestive issues, blood disorders, liver enzyme increases, seizures in those at risk, and potentially others related to antibiotic use. The exact side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am hospitalized for a serious bacterial infection and need IV antibiotics.
Select...
I have a working IV line for receiving the study drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ on day 1 at 30 minutes prior to start of first iv infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (day 2 or day 3) at 2 to 6 hours after start of any infusion that day.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on day 1 at 30 minutes prior to start of first iv infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (day 2 or day 3) at 2 to 6 hours after start of any infusion that day.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event (AE)
Percentage of Participants With One or More Adverse Event (AE)
Secondary outcome measures
Imipenem
Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of Relebactam Following Administration of IMI/REL
Concentration at End of Infusion (Ceoi) of Imipenem Following Administration of IMI/REL
+9 moreSide effects data
From 2018 Phase 3 trial • 83 Patients • NCT032934859%
Diarrhoea
9%
Nausea
6%
Nasopharyngitis
2%
Abdominal abscess
1%
Pelvic abscess
1%
Pancreatitis acute
1%
Cholecystitis acute
1%
Peritonitis
1%
Postoperative ileus
1%
Acute kidney injury
1%
Renal haematoma
1%
Large intestine perforation
1%
Rhegmatogenous retinal detachment
100%
80%
60%
40%
20%
0%
Study treatment Arm
cIAI/cUTI
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IMI/RELExperimental Treatment1 Intervention
Participants with cIAI or cUTI will receive imipenem/cilastatin/relebactam (IMI/REL) via IV infusion, once every 6 hours, for a minimum of 5 days (with optional oral switch after 3 days) up to a maximum of 14 days. Participants with HABP/VABP will receive IMI/REL via IV infusion, once every 6 hours, for a minimum of 7 days up to a maximum of 14 days. All oral switch medications will be chosen from a list of acceptable approved agents and will be administered per authorized Package Insert (PI), Summary of Product Characteristics (SPC), or international treatment guidelines.
Group II: Active ControlActive Control1 Intervention
Participants with cIAI or cUTI will receive active control via IV infusion for a minimum of 5 days (with optional oral switch after 3 days) up to a maximum of 14 days. Participants with HABP/VABP will receive active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. All active control and oral switch medications will be administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications will be chosen from a list of acceptable approved agents.
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Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,995 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,531 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,604 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with antibiotics for more than a day in the last 2 days.I am hospitalized for a serious bacterial infection and need IV antibiotics.My kidney function is below the required level or I need dialysis.My liver enzymes are significantly higher than normal.I have a history of seizures, cystic fibrosis, or serious allergies to specific antibiotics.I am expected to use or have used specific medications recently and might need antibiotics.I have a working IV line for receiving the study drug.I am at least 37 weeks postmenstrual age.I am not pregnant or breastfeeding, and if I can have children, I agree to use birth control during and after the study.I do not have infections like endocarditis or tuberculosis that could affect the study results.My lung infection is due to cancer or another blockage in my lungs.I have a complicated urinary tract infection with specific complications.My baby has been treated with antibiotics for over 72 hours to rule out meningitis before starting the IV study treatment.
Research Study Groups:
This trial has the following groups:- Group 1: IMI/REL
- Group 2: Active Control
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.
Are there any open spots for patients in this clinical trial?
"That is correct, the listing on clinicaltrials.gov affirms that this trial is still active and looking for participants. The trial was first advertised on October 8th, 2019 and has been updated as recently as September 15th, 2020. They are hoping to enroll 140 patients total at 3 locations."
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