Tuberculosis Clinical Trial
Official title:
Sputum Pharmacokinetics of TB Drugs and Bacterial Drug Resistance
Verified date | March 2022 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: Many people around the world get tuberculosis (TB) and non-tuberculous mycobacteria (NTM) infections. Sometimes medicine that treats these infections does not get to where the bacteria are in the lungs. Researchers want to find a way to tell if enough medicine is getting to where it is needed in the lungs. They will look at how much medicine is in your sputum (what you cough up) compared to how much is in your blood. They will also investigate a new test to quickly figure out what medicines are likely to treat TB effectively. Objective: To determine the relationship between the concentration of TB drugs in plasma and sputum over time. Eligibility: People ages 18 and older who have TB or NTM infection that is suspected to be drug resistant. They must be taking TB or NTM medicines. Design: Participants will be screened with medical history. Participants will be in the study for 2 8 days. Participants will give 3 or more sputum samples over at least 2 different days. They will cough sputum into a cup. Participants will have blood drawn 4 times a day on 2 different days.
Status | Completed |
Enrollment | 215 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | - 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 |
Country | Name | City | State |
---|---|---|---|
China | Henan Provincial Chest Hospital | Zhengzhou, | |
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States, China,
Dartois V. Drug forgiveness and interpatient pharmacokinetic variability in tuberculosis. J Infect Dis. 2011 Dec 15;204(12):1827-9. doi: 10.1093/infdis/jir662. Epub 2011 Oct 21. — View Citation
Peloquin C. Use of therapeutic drug monitoring in tuberculosis patients. Chest. 2004 Dec;126(6):1722-4. — View Citation
Wilkins JJ, Savic RM, Karlsson MO, Langdon G, McIlleron H, Pillai G, Smith PJ, Simonsson US. Population pharmacokinetics of rifampin in pulmonary tuberculosis patients, including a semimechanistic model to describe variable absorption. Antimicrob Agents Chemother. 2008 Jun;52(6):2138-48. doi: 10.1128/AAC.00461-07. Epub 2008 Apr 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint is the AUC (0-24) in sputum and blood. | drug-specific correlation coefficients of the AUCs for sputum and blood | 0-24 hrs | |
Secondary | drug-specific time-concentration curves, as well as drug exposure in sputum relative to that in cavity caseum | Estimation of time-concentration curves, as well as variance components of sputum PK parameters to better inform sputum PK sampling in future studies. Additionally, the relationship between drug-specific exposures in cavity caseum, from historical data, and that in sputum will be evaluated using correlation coefficients. | Throughout |
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