Imipenem/Cilastatin/Relebactam for Cystic Fibrosis

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Joseph L. Kuti, PharmD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Hartford Hospital

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Joseph L. Kuti, PharmD

Principal Investigator

Hartford Hospital

Eligibility Criteria

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.

Inclusion Criteria

APE documented or suspected (based on prior surveillance cultures) to be caused by P. aeruginosa

Documented diagnosis of CF defined based on medical history of two or more clinical features of CF and a documented sweat chloride >60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations

Hospitalized with an acute pulmonary exacerbation (APE), defined as an exacerbation of respiratory symptoms that requires intravenous antibiotics for any 4 of the following signs or symptoms: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; malaise, fatigue, or lethargy; temperature above 38C; anorexia or weight loss; change in physical examination of the chest; decrease in pulmonary function by 10 percent or more from a previously recorded value; or radiographic changes indicative of pulmonary infection.

Exclusion Criteria

Unlikely to remain hospitalized for at least 4 days to ensure pharmacokinetic sampling

Inability to perform pulmonary function tests (PFT) at baseline or 2 weeks after end of therapy

For ADULT Participants (18 years or older): Renal dysfunction defined as a creatinine clearance < 60 mL/min (calculated by the Cockcroft-Gault equation)

Treatment Details

Interventions

• Imipenem/Cilastatin/Relebactam (Beta-lactam/beta-lactamase inhibitor combination antibiotic)

Trial Overview 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.

Participant Groups

Group I: Imipenem/cilastatin/relebactam Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Hartford Hospital

Lead Sponsor

Trials

140

Recruited

19,700+

Dr. Ajay Kumar

Hartford Hospital

Chief Medical Officer since 2016

MD, University of Connecticut School of Medicine

Jeffrey A. Flaks

Hartford Hospital

Chief Executive Officer since 2019

Master's in Health Administration, George Washington University

St. Christopher's Hospital for Children

Collaborator

Trials

10

Recruited

3,300+

Connecticut Children's Medical Center

Collaborator

Trials

76

Recruited

30,000+

James E. Shmerling

Connecticut Children's Medical Center

Chief Executive Officer since 2015

Bachelor of Science in Health Education from the University of Tennessee, Master of Science in Hospital and Health Administration from the University of Alabama at Birmingham, MBA from Samford University, Doctorate of Health Administration from the Medical University of South Carolina

Dorothy A. Levine

Connecticut Children's Medical Center

Chief Medical Officer since 2022

MD

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+

Leslie C. Davis

University of Pittsburgh Medical Center

Chief Executive Officer since 2021

BA in Economics from Wesleyan University, MBA in Health Administration from The Wharton School

Don Yealy

University of Pittsburgh Medical Center

Chief Medical Officer since 2023

MD from the Pritzker School of Medicine, University of Chicago

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Q2 Solutions

Industry Sponsor

Trials

15

Recruited

1,600+

Indiana University Health Methodist Hospital

Collaborator

Trials

4

Recruited

5,300+

James Whitcomb Riley Hospital for Children

Collaborator

Trials

5

Recruited

2,400+