Status:
COMPLETED
Pharmacokinetics of Omadacycline in Cystic Fibrosis
Lead Sponsor:
Paul Beringer
Collaborating Sponsors:
Paratek Pharmaceuticals Inc
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis.
Detailed Description
Omadacycline exhibits excellent activity against bacteria including methicillin-resistant Staphylococcus aureus (MRSA), Burkholderia cepacia, and Nontuberculous mycobacteria (NTM) that are a potential...
Eligibility Criteria
Inclusion
- Diagnosis of CF based on positive sweat chloride or known CF mutation
- Age \>=18 years
Exclusion
- Presence of an ongoing acute pulmonary exacerbation defined based on clinical signs \& symptoms and an acute decline in relative FEV1 of 10% or greater.
- Pregnancy or breastfeeding
- Serious past allergy to a tetracycline antibiotic
- No alcohol, nicotine, or caffeine-containing products during the study period
- Hemoglobin \< 8 g/dL
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04460586
Start Date
July 1 2021
End Date
December 31 2023
Last Update
February 22 2024
Active Locations (1)
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1
University of Southern California
Los Angeles, California, United States, 90089