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Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02444234
Recruitment Status : Completed
First Posted : May 14, 2015
Results First Posted : June 4, 2019
Last Update Posted : June 2, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Paul Beringer, University of Southern California

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

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Tedizolid PO Drug: Tedizolid IV Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Steady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic Fibrosis
Study Start Date : July 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tedizolid PO
Tedizolid phophate 200mg tablet
 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.
Experimental: Tedizolid IV
Tedizolid phophate 200mg IV
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: 2 days ]
    Cmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose

  2. Area Under the Plasma Concentration Versus Time Curve (AUC) [ Time Frame: 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

  3. Time to Peak Plasma Concentration (Tmax) [ Time Frame: 2 days ]
    Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose

  4. Peak Sputum Concentration [ Time Frame: 2 days ]
    Peak sputum concentration was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose.

  5. Area Under the Sputum Concentration Versus Time Curve (AUC) [ Time Frame: 2 days ]
    AUC was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose

  6. Time to Peak Sputum Concentration (Tmax) [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444234


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90089
Sponsors and Collaborators
University of Southern California
Merck Sharp & Dohme Corp.
  Study Documents (Full-Text)

Documents provided by Paul Beringer, University of Southern California:
Study Protocol and Statistical Analysis Plan  [PDF] July 26, 2016

More Information
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Responsible Party: Paul Beringer, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02444234    
Other Study ID Numbers: HS-15-00182
First Posted: May 14, 2015    Key Record Dates
Results First Posted: June 4, 2019
Last Update Posted: June 2, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
 Infant, Newborn, Diseases
Tedizolid
Oxazolidinones
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action