Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis

Phase 4

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: Tedizolid PO; Drug: Tedizolid IV

• Registration Number: NCT02444234
• Lead Sponsor: University of Southern California

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-11
• Study First Posted: 2015-05-14
• Study Start: 2015-07
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Results First Submitted: 2019-04-25
• Results First Submitted QC: 2019-05-15
• Results First Posted: 2019-06-04
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-21
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tedizolid PO	Tedizolid PO	Tedizolid phophate 200mg tablet
Tedizolid IV	Tedizolid IV	Tedizolid phophate 200mg IV

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax)	2 days	Cmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC)	2 days	Area under the curve was calculated using samples collected at baseline (0 h) , 0.5, 1, 2, 3, 4, 8, 24, and 48 hours post-dose and using the equation AUC=Dose\*F/CL
Time to Peak Plasma Concentration (Tmax)	2 days	Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
Peak Sputum Concentration	2 days	Peak sputum concentration was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose.
Area Under the Sputum Concentration Versus Time Curve (AUC)	2 days	AUC was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
Time to Peak Sputum Concentration (Tmax)	2 days	Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose. Tmax was derived from pooled sputum data due to sparse samples and therefore do not have standard deviations.

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States