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A novel method for evaluating the antimicrobial activity of tuberculosis treatment regimens

Authors: Gillespie, S. H.; Charalambous, B. M.

Source: The International Journal of Tuberculosis and Lung Disease, Volume 7, Number 7, July 2003 , pp. 684-689(6)

Publisher: International Union Against Tuberculosis and Lung Disease

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Abstract:

OBJECTIVE: To evaluate the clinical response to anti-tuberculosis chemotherapy rapidly.

METHOD: Sputum viable counts from a previously published clinical trial comparing a standard regimen and one containing isoniazid, rifampicin and ciprofloxacin were re-evaluated using an exponential decay model. The results were fitted to a one or two phase exponential decline. The decline in viable counts followed a curve described by a single-phase exponential decay model. From these data the time taken to reduce the viable count by 50% (vt50) was calculated to estimate the bactericidal effect of the regimens.

RESULTS and CONCLUSION: This method shows promise as a means for early identification of patients who are responding poorly as a result of resistance or poor immune response and for comparing anti-tuberculosis regimens in clinical trials. The failure to show a two-phase exponential decay curve suggested that either the sputum does not contain bacteria upon which only drugs with a sterilising activity act or that they are not present in sufficient numbers to have a significant impact on the total viable count. Further studies are required to understand the physiological state of organisms being sampled in sputum.

Keywords: clinical trials; drug effects; mathematical model

Document Type: Regular Paper

Affiliations: Department of Medical Microbiology, University College London, London, UK

Publication date: July 1, 2003

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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