Status:
COMPLETED
Pharmacokinetics of Polymyxin B in Adult Patients With Cystic Fibrosis
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Polymyxin B
Eligibility:
All Genders
18+ years
Brief 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 aer...
Detailed Description
This study initially planned to include "Change in forced expiratory volume in one second (FEV1)" and "Non-response to therapy" as secondary outcome measures. These outcome measures were removed, as t...
Eligibility Criteria
Inclusion
- Adults ≥ 18 years of age.
- Diagnosis of CF.
- Receiving polymyxin B in the course of routine care.
Exclusion
- Evidence of acute kidney injury during the 48 hours prior to and following initiation of PMB therapy.
- Extracorporeal organ support (including ECMO, iHD, and CRRT).
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
January 9 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04335370
Start Date
January 9 2019
End Date
July 1 2021
Last Update
July 25 2023
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109