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Protocol Details

Sputum Pharmacokinetics of TB Drugs and Bacterial Drug Resistance

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-I-0187

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Pharmacokinetic-Moedeling;
Tuberculosis;
Therapeutic Drug Monitoring;
Drug-Levels;
Caseum;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Tuberculosis;
Non-Tuberculosis Mycobacteria

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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.

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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


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Citations:

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.

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.

Peloquin C. Use of therapeutic drug monitoring in tuberculosis patients. Chest. 2004 Dec;126(6):1722-4.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Clifton E. Barry III, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)



Joel P. Vincent
National Institute of Allergy and Infectious Diseases (NIAID)
BG 33 RM 2W20
33 NORTH DR
BETHESDA MD 20814
(301) 761-7577
joel.vincent@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT02534727

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