MedTrace Logo

Utility of MODS for Diagnosis of MDR-TB and Second-Line Antituberculous Drug Susceptibility Testing in Mali

NCT01381757 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2018-04-05

No results posted yet for this study

Summary

Background:

-Tuberculosis (TB) is an infection of the lungs caused by bacteria. In Mali, TB is diagnosed with a test that is fast and inexpensive but not always accurate. The purpose of this study is to test a new method for diagnosing TB, called the microscopic-observation drug-susceptibility (MODS) test. The MODS test takes 7 days to show results. The test also gives information on which drugs will work best in each case.

Objective:

-To test a new method for diagnosing tuberculosis called the microscopic observation drug susceptibility test.

Eligibility:

* Participants must be 12 years of age or older.
* They must have a diagnosis of TB from a sputum smear, or have symptoms of TB and an x-ray indicating that TB is present.

Design:

* Participants will take part in the study from 6 months to 21 months and be assigned to one of three groups, depending on what type of TB they have.
* At the first visit, researchers ask questions about general health and symptoms of TB. They check vital signs, draw blood, and ask for a sputum sample. The blood is used to check for HIV infection and for the number of CD4 cells, which measures the severity of the HIV infection.
* The 2-, 5-, and 6-month visits are similar to the first. Those who do not have multidrug-resistant (MDR) TB will end their participation after the 6-month visit. MDR TB is tuberculosis that has not responded to isoniazid and rifampicin. Participants with MDR TB will remain in the study for 21 months.
* No treatment is provided as part of this study.

Conditions

  • Tuberculosis, Pulmonary
  • Mycobacterium Tuberculous
  • Antitubercular Agents
  • Tuberculosis, Mulutidrug-Resistant
  • Extensively Drug-Resistant
  • Extensibely Drug-Resistant Tuberculosis

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Sophia B Siddiqui, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Completion
2013-03-05

Countries

  • United States
  • Mali

Study Locations

More Related Trials

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 NCT01381757 on ClinicalTrials.gov