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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational



Official Title: Uitlity of MODS for the Diagnosis of MDR-TB and Second-Line Antituberculous Drug Susceptibility Testing in Mali

Brief 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