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

Stopped early

Conditions studied: Tuberculosis, Pulmonary, Mycobacterium Tuberculous, Antitubercular Agents, Tuberculosis, Mulutidrug-Resistant, Extensively Drug-Resistant, Extensibely Drug-Resistant Tuberculosis

In brief

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.

Key facts

Study ID

NCT01381757

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

34

Starts

2011-05-31

Expected to finish

2013-03-05

Last updated by the study team

2018-04-05

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects who meet any of the following criteria are not eligible for enrollment in the study:
• Any condition that in the investigator s opinion places the subject at undue risk by participating in the study.
• Subjects younger than 12 years of age will be excluded from the study due to the difficulty of obtaining adequate sputum samples for the diagnosis of TB in this population and because there are no means for obtaining gastric aspirates at the reference centers.

Where it is running

• National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi — Bethesda, Maryland, United States
• University of Bamako — Bamako, Mali

Full record on ClinicalTrials.gov

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