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NCT05561764 · ClinicalTrials.gov registry record · Phase 4
Imipenem/Cilastatin/Relebactam Pharmacokinetics, Safety, and Outcomes in Adults and Adolescents With Cystic Fibrosis
A Phase 4 study, sponsored by Hartford Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT05561764 is a Phase 4 study that was terminated before completion, run by Hartford Hospital. The registered enrollment target is 4 participants.
The verdict
NCT05561764, a Phase 4 study, was terminated before completion, sponsored by Hartford Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
There is established evidence that patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Imipenem/cilastatin/relebactam is a novel broad spectrum intravenous beta-lactam/beta-lactamase inhibitor combination antibiotic with potent activity against multidrug resistant Gram-negative bacteria, including imipenem non-susceptible Pseudomonas aeruginosa. Relebactam has also been shown to restore imipenem activity in Burkholderia cepacia complex, a group of opportunistic multidrug resistant pathogens that commonly infect patients with CF. This study will determine the pharmacokinetics and tolerability of imipenem/cilastatin/relebactam in 16 adolescent and adult patients with CF acute pulmonary exacerbations at one of seven participating hospitals in the US, with exploratory aim of reporting relative percent increase in FEV1 from pre- to post-treatment and return to baseline FEV1 after treatment with imipenem/cilastatin/relebactam for acute pulmonary exacerbations due to P. aeruginosa in patients with CF. Patients will receive a 10-14 day course of imipenem/cilastatin/relebactam, dosed according to renal function every 6 hours over 30 mins, with or without adjunctive aminoglycoside or fluoroquinolone therapy per local hospital guidelines. Blood will be sampled during one dosing interval at steady-state (i.e. after at least 3 doses) to determine concentrations and pharmacokinetics of imipenem and relebactam. Relative change in pulmonary function will be assessed two weeks after end of therapy. Safety and tolerability will be assessed throughout the duration of the study.
Interventions
- DRUG Imipenem/Cilastatin/Relebactam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2023-01-03 |
| Est. Completion | 2024-12-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05561764
The ClinicalTrials.gov registry entry for NCT05561764 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hartford Hospital, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Imipenem/Cilastatin/Relebactam is the first listed.
NCT05561764 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05561764 about?
NCT05561764 is a clinical study titled "Imipenem/Cilastatin/Relebactam Pharmacokinetics, Safety, and Outcomes in Adults and Adolescents With Cystic Fibrosis". There is established evidence that patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Imipenem/cilastatin/relebactam is a novel broad spectrum intravenous beta-lactam/beta-lactamase inhibitor combination antibiotic with potent activity agai...
What is the current status of trial NCT05561764?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2023-01-03. Estimated completion is 2024-12-11.
What interventions are being tested in trial NCT05561764?
The interventions under investigation include: Imipenem/Cilastatin/Relebactam (DRUG).
Who is sponsoring clinical trial NCT05561764?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
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