Pilot Study of the Utility of New Surrogate Microbial Markers to Assess in vivo Antimicrobial Activity in HIV-infected and HIV-uninfected Adults with Pulmonary Tuberculosis Receiving Standard Drug Therapy
Information:
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Type of Study |
Prospective multi-center observational study |
|---|---|
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Design |
Case control study |
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Project Site |
Kampala, Uganda |
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Sample Size |
total 25 subjects at each site |
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Population |
Male or female, adults 18-60 years old
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Study Period |
1995-2001 |
Goal of Study:
The pilot surrogate microbial marker studies of the TB Research Unit has two goals: first, to evaluate the performance characteristics of new microbiologic and molecular biologic techniques and assays in a group of HIV-non-infected and HIV-infected adults with sputum smear positive tuberculosis and then, secondly, to validate the utility of promising techniques in prospective studies and clinical trials. The study is an ongoing study at multiple sites to facilitate the rapid evaluation of new methods of assessing microbial response to therapy in human TB.
Objectives of Study:
- To allow assessment of the ability of the microbial test under study to detect rapid early changes bacillary load during the early part of treatment
- To compare standard assays to new surrogate microbial marker investigational assays
The results of the completed study can be found in:
DesJardin L, Perkins M, Wolski K, Haun S, Teixeira L, Chen Y, Johnson JL, Ellner JJ, Dietze R, Bates J, Cave MD, Eisenach K. . Am J Respir Crit Care Med 1999; 160:203-210.
DesJardin LE, Perkins MD, Teixeira L, Cave MD, Eisenach KD. . J Clin Microbiol 1996; 34:2435-2439. PMCID: PMC229288.