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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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4 April 2022 |
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Main ID: |
NCT02534727 |
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Date of registration:
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26/08/2015 |
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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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Sputum Pharmacokinetics of TB Drugs and Bacterial Drug Resistance
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Scientific title:
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Sputum Pharmacokinetics of TB Drugs and Bacterial Drug Resistance |
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Date of first enrolment:
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January 27, 2016 |
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Target sample size:
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215 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02534727 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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China
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United States
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Contacts
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Name:
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Clifton E Barry, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Allergy and Infectious Diseases (NIAID) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
1. At least 18 years of age
2. Diagnosis of TB (and/or NTM for NIH clinical center subjects)
3. Ongoing signs and/or symptoms of pulmonary TB (and/or NTM at the NIH CC)
4. Suspected drug resistance (drug susceptible allowed at the NIH CC)
5. Available to provide at least 3 sputa over 2 or more days
6. Taking anti-tuberculosis medicines (or NTM meds at NIH CC) during the time sputa
are provided
7. Thought likely to be Mycobacterium culture positive (including NTM infected for
the NIH CC) by enrolling physician
8. GeneXpert MTB/RIF sputum TBpositive (China subjects only)
9. Likely able to produce sputum samples while on study
10. Willing to provide blood samples
11. Willing to have samples stored
EXCLUSION CRITERIA:
1. Acute liver or kidney disease
2. Conditions which compromise the subject s ability to take or absorb oral drugs
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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Tuberculosis
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Non-Tuberculosis Mycobacteria
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Primary Outcome(s)
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The primary endpoint is the AUC (0-24) in sputum and blood.
[Time Frame: 0-24 hrs]
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Secondary Outcome(s)
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drug-specific time-concentration curves, as well as drug exposure in sputum relative to that in cavity caseum
[Time Frame: Throughout]
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Secondary ID(s)
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150187
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15-I-0187
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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