NCT04335370

Pharmacokinetics of Polymyxin B in Adult Patients With Cystic Fibrosis

Completed Last updated 25 July 2023

What this trial tests

trial testing Blood Draw in Cystic Fibrosis in 9 participants. Completed in 1 July 2021.

Timeline

9 January 2019

Primary endpoint
1 July 2021

1 July 2021

Quick facts

Lead sponsor	University of Michigan
Status	Completed
Study type	OBSERVATIONAL
Enrollment	9
Start date	9 January 2019
Primary completion	1 July 2021
Estimated completion	1 July 2021
Sites	1 location across United States

Drugs / interventions tested

• Blood Draw — full drug profile →

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →
• Polymyxin B — all drugs for Polymyxin B →

Sponsor

University of Michigan

Who can join

18 and older, any sex, with Cystic Fibrosis or Polymyxin B. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 pharmacokinetics and toxicities of fixed-dose PMB in CF and will guide optimal use of this compound in the management of acute pulmonary exacerbations.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.