Your session is about to expire
← Back to Search
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
Study Summary
This trial will study the effects of a new broad spectrum antibiotic, given to patients with Cystic Fibrosis who are experiencing an acute pulmonary exacerbation. The goal is to see if the new drug is safe and effective, and if it improves the patients' symptoms.
Eligible Conditions
- Cystic Fibrosis
- Bacterial Pneumonia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Imipenem
Imipenem Volume of Distribution
Relebactam Clearance
+1 moreSecondary outcome measures
Probability of Target Attainment at 2 mg/L
Other outcome measures
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%
Respiratory failure
2%
Diarrhea
2%
Infusion related reaction
2%
Anorectal Infection
2%
Hyperglycemia
2%
Allergic Reaction
2%
Genital edema
2%
Pleural effusion
2%
Bacteremia
2%
Rash Maculo-papular
2%
Fungemia
2%
Hypokalemia
2%
Hematuria
2%
Peripheral Sensory Neuropathy
2%
Arterial thromboembolism
2%
Urinary Tract Infection
2%
Confusion
2%
Appendicitis
2%
Nervous system disorders - Other: Ring-enhancing brain lesions
2%
Atrial fibrillation
2%
Soft Tissue Infection
2%
Colonic Obstruction
2%
Fall
2%
Heart Failure
2%
Ascites
2%
Edema limbs
2%
Sinusitis
2%
Jejunal perforation
2%
Aspartate Aminotransferase Increased
2%
Intracranial Hemorrhage
2%
Immune system disorders - Other: ICANS
2%
Skin and subcutaneous tissue disorders - Other red rash
2%
skin infection
2%
Soft Tissue Infection - Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imipenem-Relebactam Arm
Group II (Cefepime, Meropenem, Piperacillin/Tazobactam)
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
71 Previous Clinical Trials
31,498 Total Patients Enrolled
University of Texas Southwestern Medical CenterOTHER
1,047 Previous Clinical Trials
1,053,783 Total Patients Enrolled
10 Trials studying Cystic Fibrosis
389 Patients Enrolled for Cystic Fibrosis
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:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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 volunteers still being accepted for this clinical endeavor?
"As per information from clinicaltrials.gov, this medical trial is no longer recruiting patients - the initial posting date was December 1st 2022 and it had not been updated since September 29th 2022. However, 419 other trials are actively searching for participants at present."
Answered by AI
How widespread is the implementation of this trial?
"The current trial is being administered from 8 sites: IU Health University Hospital in Indianapolis, Indiana; Hartford Hospital in Philadelphia, Pennsylvania; St. Christopher's Hospital for Children in Pittsburgh, Texas and 5 other clinical centres."
Answered by AI
What implications does the use of Imipenem/cilastatin/relebactam have for patient safety?
"Data collected from our research team at Power provide evidence that Imipenem/cilastatin/relebactam is an approved treatment and therefore safe, thus granting it a score of 3."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger