Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis

University of Southern California

Status and phase: Completed; Phase 4

Conditions: Cystic Fibrosis

Treatments: Drug: Tedizolid IV; Drug: Tedizolid PO

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02444234

HS-15-00182

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of CF based on positive sweat chloride or known CF mutation
• Age > 17 years
• Able to spontaneously expectorate sputum

Exclusion criteria

• Any clinically significant laboratory abnormalities
• Presence of an ongoing acute pulmonary exacerbation
• Pregnancy
• Serious past allergy to linezolid or tedizolid
• No alcohol, nicotine, or caffeine-containing products during the study period

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Tedizolid PO

Experimental group

Description:

Tedizolid phophate 200mg tablet

Treatment:

Drug: Tedizolid PO

Tedizolid IV

Experimental group

Description:

Tedizolid phophate 200mg IV

Treatment:

Drug: Tedizolid IV