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NCT02534727 · ClinicalTrials.gov registry record

Sputum Pharmacokinetics of TB Drugs and Bacterial Drug Resistance

A clinical trial of Tuberculosis and Non-Tuberculosis Mycobacteria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
215
Enrollment target
2
Study locations

NCT02534727 is a study of Tuberculosis and Non-Tuberculosis Mycobacteria that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 215 participants, below the 927-participant average among 29 other Tuberculosis trials with a reported enrollment target (77% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT02534727, a study of Tuberculosis and Non-Tuberculosis Mycobacteria, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
215 participants
Enrollment target
2
Study locations

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.

Study Locations (2)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Other

  • Henan Provincial Chest Hospital - Zhengzhou

Trial Details

FieldValue
Enrollment Target 215 participants
Start Date 2016-01-27
Est. Completion 2020-12-31

What the Registry Record Tells You About NCT02534727

The ClinicalTrials.gov registry entry for NCT02534727 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 927-participant average among 29 other Tuberculosis trials with a reported enrollment target (77% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Tuberculosis appearing as the primary indexed condition, and to 0 interventions.

NCT02534727 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Other.

Frequently Asked Questions

What is clinical trial NCT02534727 about?

NCT02534727 is a clinical study titled "Sputum Pharmacokinetics of TB Drugs and Bacterial Drug Resistance". 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 ...

What is the current status of trial NCT02534727?

This trial is currently completed. The enrollment target is 215 participants. The study started on 2016-01-27. Estimated completion is 2020-12-31.

What conditions does trial NCT02534727 study?

This clinical trial studies the following conditions: Tuberculosis, Non-Tuberculosis Mycobacteria.

Who is sponsoring clinical trial NCT02534727?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02534727 being conducted?

This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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