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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02444234 |
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Date of registration:
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06/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis
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Scientific title:
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Steady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic Fibrosis |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02444234 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Tedizolid IV
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Drug: Tedizolid PO
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Primary Outcome(s)
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Peak Sputum Concentration
[Time Frame: 2 days]
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Area Under the Plasma Concentration Versus Time Curve (AUC)
[Time Frame: 2 days]
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Time to Peak Plasma Concentration (Tmax)
[Time Frame: 2 days]
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Area Under the Sputum Concentration Versus Time Curve (AUC)
[Time Frame: 2 days]
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Peak Plasma Concentration (Cmax)
[Time Frame: 2 days]
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Time to Peak Sputum Concentration (Tmax)
[Time Frame: 2 days]
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Secondary ID(s)
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HS-15-00182
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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