Evaluation of alternative bacteriological measures of response to therapy during the initial 16-weeks of MDR-TB (drug resistant tuberculosis) treatment
Not Applicable
- Conditions
- Alternative measures of response to MDR-TB (drug-resistant tuberculosis) therapyInfections and Infestations
- Registration Number
- ISRCTN45714844
- Lead Sponsor
- Makerere University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 59
Inclusion Criteria
1. Adults >18 years of age
2. Have a productive cough
3. Sputum specimens that are positive for acid fast bacilli by microscopy (1+ to 3+, smear-positive)
4. Have been classified as MDR TB
Exclusion Criteria
1. Prisoners
2. Subjects <18 years of age
3. Patients who are unable to provide =3mL of sputum specimen for testing
4. Patients on anti-TB treatment
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sputum bacterial load burden, measured using Culture colony forming units (CFUs) as a reference standard, with MGIT time to positivity, Xpert PMA, FDA, Smear Microscopy, and TB-MBLA measured at weeks 0, 2, 4, 6, 8, 12 and 16
- Secondary Outcome Measures
Name Time Method <br> 1. Patient clinical characteristics will be collected using a detailed data collection tool at baseline (week 0)<br> 2. Baseline resistance profiles will be collected from the existing patient records at the clinic and tested using phenotypic drug susceptibility testing (DST) whenever possible<br> 3. Adherence measured using available clinical data and as collected by the study nurse during MDR-TB treatment<br> 4. HIV-status will be collected as documented in the clinic patient records at baseline<br>