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NCT04335370 · ClinicalTrials.gov registry record
Pharmacokinetics of Polymyxin B in Adult Patients With Cystic Fibrosis
A clinical trial, sponsored by University of Michigan.
- Completed
- Registry status
- 9
- Enrollment target
NCT04335370 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 9 participants.
The verdict
NCT04335370 has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 9 participants
- Enrollment target
Study Summary
Cystic fibrosis (CF) pulmonary disease is a major cause of morbidity and mortality in CF patients and is punctuated by episodes of acute exacerbation that require antibiotic treatment. Pseudomonas aeruginosa is the predominant bacterial pathogen isolated in patients with acute exacerbations, and practice guidelines recommend combination antibiotics directed against this pathogen as initial therapy. Such therapy traditionally consists of an antipseudomonal beta-lactam with either an antipseudomonal fluoroquinolone or an aminoglycoside. With growing P. aeruginosa multi-drug resistance, more adult patients present with isolates resistant to these traditional options. The polymyxins are a class of cyclic peptide antibiotics that exert bactericidal activity through binding to the lipopolysaccharide component of gram-negative bacterial membranes and include colistin and polymyxin B (PMB). In recent years, there is growing evidence of increased rates of acute kidney injury associated with colistin in critically ill patients. Additionally, population pharmacokinetic (PK) studies suggest that fixed drug dosing may yield an improved therapeutic index over the traditional weight-based dosing of this agent. Thus there is growing interest in use of PMB as an alternative in CF acute exacerbations but the optimal dosage regimen is not known. This is a single-center, open-label, non-interventional study to characterize the pharmacokinetics and safety of fixed-dose PMB in adult patients with CF by measuring serum concentrations in patients receiving IV therapy as a part of routine care. This study will help to validate existing population PK models and allow for adjustment of patient specific covariates (i.e. weight, renal function) unique to adult patients with CF. The study will also monitor for nephrotoxicity and neurotoxicity to determine if PMB has an acceptable margin of safety in this patient population. This investigation is the first to prospectively validate the pharmaco
Interventions
- OTHER Blood Draw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2019-01-09 |
| Est. Completion | 2021-07-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04335370
The ClinicalTrials.gov registry entry for NCT04335370 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Blood Draw is the first listed.
NCT04335370 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04335370 about?
NCT04335370 is a clinical study titled "Pharmacokinetics of Polymyxin B in Adult Patients With Cystic Fibrosis". Cystic fibrosis (CF) pulmonary disease is a major cause of morbidity and mortality in CF patients and is punctuated by episodes of acute exacerbation that require antibiotic treatment. Pseudomonas aeruginosa is the predominant bacterial pathogen isolated in patients with acute exacerbations, and pra...
What is the current status of trial NCT04335370?
This trial is currently completed. The enrollment target is 9 participants. The study started on 2019-01-09. Estimated completion is 2021-07-01.
What interventions are being tested in trial NCT04335370?
The interventions under investigation include: Blood Draw (OTHER).
Who is sponsoring clinical trial NCT04335370?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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