Microbiology Pilot Study | Tuberculosis Research Unit

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:

Type of Study	Prospective multi-center observational study
Design	Case control study
Project Site	Kampala, Uganda Vitoria, Brazil New York, New York, USA Miami, Florida, USA
Sample Size	total 25 subjects at each site
Population	Male or female, adults 18-60 years old 10 adults HIV-infected and 10 adults HIV-non-infected with newly diagnosed initial episodes of smear positive/culture confirmed pulmonary tuberculosis 5 adults with suppurative respiratory diseases other than tuberculosis
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. Measurement of sputum Mycobacterium tuberculosis messenger RNA as a surrogate for response to chemotherapy. Am J Respir Crit Care Med 1999; 160:203-210.

DesJardin LE, Perkins MD, Teixeira L, Cave MD, Eisenach KD. Alkaline decontamination of sputum specimens adversely affects stability of mycobacterial mRNA. J Clin Microbiol 1996; 34:2435-2439. PMCID: PMC229288.