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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Jun 23, 2011

Keywords

ClinConnect Summary

Approximately one-third of the world s population is infected with tuberculosis (TB), and over 1 million deaths occur annually worldwide because of it (1,2). Accurate diagnosis and TB drug susceptibility testing is necessary to treat the infection appropriately and bring this epidemic under control. Inappropriate treatment of TB, on the other hand, has led to the recent spread in multidrug-resistant TB (MDR-TB), estimated to affect over half of million people worldwide (2,4,5). Sputum smear microscopy, the diagnostic method commonly used in developing countries, is not as sensitive at detec...

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Eligibility criteria

• * INCLUSION CRITERIA:
• Individuals (12 years of age) who meet the following criteria are eligible for enrollment in the study:
• • Have a sputum smear that is positive for acid-fast bacilli by microscopy or have clinical symptoms and abnormal findings compatible with active TB on a previously performed chest radiograph.
• • Have either completed at least 5 months of treatment with antituberculous therapy within the past year or have not received any antituberculous treatment in the preceding 5 years.
• • Willingness to provide a sputum sample for the study.
• • Ability to follow verbal instructions for producing sputum.
• • Willingness to undergo testing for HIV.
• • Willingness to allow storage of samples for future research.
• EXCLUSION CRITERIA:
• 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.