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Sputum Pharmacokinetics of TB Drugs and Bacterial Drug Resistance

NCT02534727 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 215

Last updated 2022-03-29

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-27
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United States
  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02534727 on ClinicalTrials.gov