Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-12-31

Brief Summary

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

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Detailed Description

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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

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Tedizolid PO

Tedizolid phophate 200mg tablet

Group Type EXPERIMENTAL

Tedizolid PO

Intervention Type DRUG

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

Tedizolid IV

Tedizolid phophate 200mg IV

Group Type EXPERIMENTAL

Tedizolid IV

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No