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OFLOTUB


Tuberculosis (INCO)

A Multicentre, Randomised, Control Trial of Ofloxacine-Containing, Short-Course Regimen for the Treatment of Pulmonary Tuberculosis
Framework programme:
5
Project number:
ICA4-CT-2002-10126
EC contribution:
€ 2 392 830
Duration:
48 months
Type:
RS
Starting date:
1 December 2001

Summary:

The present research proposal seeks to assess the bacteriological and clinical efficacy of an ofloxacin-containing, short-course regimen for the treatment of pulmonary TB in comparison with the standard six-month, short-course regimen. It is a multicentre, randomised, controlled trial that will be conducted jointly in five countries in Africa, with the collaboration of five European institutions, using a standardised methodology. Surrogate studies of the sterilising activity of the two regimens will be carried out in parallel. This study is expected to provide a relevant assessment of the possibility to reduce further and effectively the duration of treatment of pulmonary TB, with the aim of obtaining good adherence of the patients to treatment, and thus increase TB cure rates. In addition, it will contribute to the development of capacities to establish a network of centres aimed at conducting clinical trials in Africa based around sites of excellence for field research.

Objectives:

The overall objective of the project is to evaluate the efficacy of an ofloxacin-containing drug regimen for shortening the duration of treatment of pulmonary TB in developing countries. The specific scientific objectives are:

1) to evaluate the efficacy of an ofloxacin-containing, four-month combined regimen in the treatment of pulmonary TB in comparison with a standard six-month short-course regimen
2) to compare the sterilising activities of the two regimens during their intensive phase using the methods which correlate with ultimate relapse rates
3) to develop research capacities to conduct clinical trials in developing countries and provide the necessary infrastructure through appropriate training and technology transfer
4) to reinforce structures aimed at conducting clinical trials in developing countries with the aim of developing a clinical trial centres network based around sites of excellence for field research.

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