NCT02444234

Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis

Steady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic Fibrosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with Cystic Fibrosis.

Detailed description

Recent epidemiological studies have demonstrated that the presence of methicillin-resistant Staphylococcus aureus (MRSA) in the airways of patients with CF is associated with more rapid lung function decline and a higher mortality. Tedizolid is a new antibiotic with potent activity against MRSA. Tedizolid is currently FDA approved for treatment of skin soft tissue infections with MRSA. The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with CF.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Tedizolid PO	Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.
DRUG	Tedizolid IV	Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2015-05-14
• Last updated: 2020-06-02
• Results posted: 2019-06-04

Locations

1 site across 1 country: United States