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Beta-lactam/beta-lactamase inhibitor combination antibiotic
Imipenem/Cilastatin/Relebactam for Cystic Fibrosis
Phase 4
Recruiting
Led By Joseph L. Kuti, PharmD
Research Sponsored by Hartford Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
Summary
This trial tests a combination of three medications given through a drip to treat difficult lung infections in adolescents and adults with Cystic Fibrosis. The treatment aims to help those who don't respond well to regular medications by using drugs that work together to kill tough bacteria.
Who is the study for?
Adults and adolescents with Cystic Fibrosis who are hospitalized for acute pulmonary exacerbations suspected to be caused by P. aeruginosa can join this trial. They must have a confirmed diagnosis of CF, be able to perform lung function tests, and not have severe kidney or liver issues. Pregnant or breastfeeding women and those with certain infections or using specific medications cannot participate.
What is being tested?
The study is testing the antibiotic combination Imipenem/Cilastatin/Relebactam in patients with CF during an acute lung infection. It aims to understand how the body processes the drug, its safety, and if it improves breathing outcomes after treatment.
What are the potential side effects?
Possible side effects may include allergic reactions similar to other antibiotics like rashes, gastrointestinal issues such as nausea or diarrhea, changes in blood test results indicating liver or kidney function alterations, and potential interactions with other drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Imipenem
Imipenem Volume of Distribution
Relebactam Clearance
+1 moreSecondary study objectives
Probability of Target Attainment at 2 mg/L
Other study objectives
Pulmonary Function
Side effects data
From 2023 Phase 2 trial • 100 Patients • NCT0498390127%
Febrile Neutropenia
16%
Lung Infection
16%
Sepsis
4%
Catheter related bloodstream infection
4%
Vomiting
4%
Fever
2%
Nervous system disorders - Other: Ring-enhancing brain lesions
2%
Hypokalemia
2%
Arterial thromboembolism
2%
Diarrhea
2%
Jejunal perforation
2%
Fungemia
2%
Urinary Tract Infection
2%
Intracranial Hemorrhage
2%
Respiratory failure
2%
Rash Maculo-papular
2%
Confusion
2%
Peripheral Sensory Neuropathy
2%
Edema limbs
2%
Hematuria
2%
Infusion related reaction
2%
Allergic Reaction
2%
Aspartate Aminotransferase Increased
2%
Skin and subcutaneous tissue disorders - Other red rash
2%
Appendicitis
2%
Bacteremia
2%
Soft Tissue Infection - Cellulitis
2%
Fall
2%
Hyperglycemia
2%
Immune system disorders - Other: ICANS
2%
Heart Failure
2%
Colonic Obstruction
2%
Atrial fibrillation
2%
Ascites
2%
Anorectal Infection
2%
Sinusitis
2%
skin infection
2%
Soft Tissue Infection
2%
Genital edema
2%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imipenem-Relebactam Arm
Group II (Cefepime, Meropenem, Piperacillin/Tazobactam)
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Adult participants will receive intravenous imipenem/cilastatin/relebactam at a dosing regimen consistent with the current prescribing information and according to estimated renal function. Adolescent participants will receive intravenous imipenem/cilastatin/relebactam at a dosing regimen consistent with Phase I data \[37.5 (15/15/7.5) mg/kg, up to a maximum dose of 1.25g\]. Each dose will be infused over 30 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imipenem/Cilastatin/Relebactam
2021
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
St. Christopher's Hospital for ChildrenOTHER
9 Previous Clinical Trials
3,285 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
21 Patients Enrolled for Cystic Fibrosis
Connecticut Children's Medical CenterOTHER
73 Previous Clinical Trials
26,589 Total Patients Enrolled
University of Texas Southwestern Medical CenterOTHER
1,087 Previous Clinical Trials
1,059,036 Total Patients Enrolled
10 Trials studying Cystic Fibrosis
389 Patients Enrolled for Cystic Fibrosis
University of Pittsburgh Medical CenterOTHER
74 Previous Clinical Trials
76,893 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
12 Patients Enrolled for Cystic Fibrosis
Hartford HospitalLead Sponsor
138 Previous Clinical Trials
19,381 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
12 Patients Enrolled for Cystic Fibrosis
Merck Sharp & Dohme LLCIndustry Sponsor
4,031 Previous Clinical Trials
5,189,703 Total Patients Enrolled
12 Trials studying Cystic Fibrosis
1,577 Patients Enrolled for Cystic Fibrosis
Q2 SolutionsIndustry Sponsor
14 Previous Clinical Trials
1,649 Total Patients Enrolled
Indiana University Health Methodist HospitalOTHER
3 Previous Clinical Trials
5,271 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
12 Patients Enrolled for Cystic Fibrosis
James Whitcomb Riley Hospital for ChildrenOTHER
4 Previous Clinical Trials
2,346 Total Patients Enrolled
Joseph L. Kuti, PharmDPrincipal InvestigatorHartford Hospital
1 Previous Clinical Trials
8 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently using or planning to use any antibiotics that are inhaled.You have taken or plan to take imipenem or valproic acid within 7 days before receiving the study drug.You have a disease that is rapidly getting worse or a life-threatening illness that is expected to cause death within the next 48 hours, according to the doctor's opinion.You cannot receive any other intravenous antibiotic therapy, except aminoglycosides or fluoroquinolones. However, if you are taking azithromycin as a long-term treatment to reduce flare-ups, that is allowed. It is common to use a combination of antibiotics to treat certain infections in people with CF. This will not affect our main goal, but we will consider it when assessing our secondary goal.You have had a serious allergic reaction to certain antibiotics called β-lactam agents in the past, but a mild rash doesn't count.
Research Study Groups:
This trial has the following groups:- Group 1: Imipenem/cilastatin/relebactam
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.