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

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.

Description:

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. It is a multicentre, randomised, controlled trial that will be conducted jointly in five countries in Africa, with the collaboration and support of five European institutions, using a standardised methodology.

Work Package 1: It is first proposed to assemble all collaborators in an initial coordination meeting during which the clear details of the trial will be worked out, tasks and responsibilities clearly defined. An independent trial steering committee will be nominated and a consortium agreement between partners concluded.

Work Package 2: A fully detailed field manual on the conduct of the trial will be written, including the development of standard operating procedures (SOPs). These SOPs will describe precisely the methods of the trial including the recruitment of patients, their eligibility and exclusion criteria, follow-up of patients, clinical and microbiological aspects, collection of clinical data, centralisation and management of data and checking procedures.

Work Package 3: Similarly, all bacteriology tests and measurements will be fully described and standardised (smear microscopy, culture and sensitivity testing) and quality assessment ensured through a reference laboratory.

Work Package 4: Surrogate studies of the sterilising ability of the two regimens will be carried out including early bactericidal activity (EBA), a study of serial sputum viable counts, mRNA and bacterial tolerance studies.

Work Package 5: The trial centres will be upgraded to provide GCP, including training of appropriate trial researchers.

Work Package 6: Multicentre Randomised Controlled Trial. The day-to-day activities of the trial will be supervised by a clinical research officer (CRO). In each collaborating centre, a clinical research associate (CRA) will be responsible for the organisation and conduct of the trial. The CRAs will be trained specifically on the trial methods, GCP and supervision of the trial prior to its commencement.

Work Package 7: Data management and analysis. This involves creating a master database for the management of data and setting up an Internet website for the exchange of information, circulation of reports, transfer of databases and dissemination of results and findings.

Milestones:

This study is expected to provide a relevant assessment of the possibility to reduce further and effectively the duration of treatment of pulmonary TB, through a four-month combined regimen including ofloxacin. If successful, this short-course regimen could contribute further to obtaining good adherence of the patients’ treatment and thus increase TB cure rates. In addition, through the participation of several centres in Africa, it will contribute to the development of capacities to establish a network of centres aiming at conducting clinical trials in Africa based around sites of excellence for field research.

Coordinator:

Christian Lienhardt
Institut de Recherche pour le Développement (IRD)
Département Sociétés et Sante
PO BOX 1386
Route des Pères Maristes
Dakar-Hann, Senegal
Tel: +221 849 3562
Fax: lienhardt@dakar.ird.sn

Partners:

  1. Service de Pneumo-Phtisiologie, CHU Ignace Deen, Conakry, Republic of Guinea
  2. Assistance Publique - Hôpitaux de Paris - Service de Maladies Infectieuses et Tropicales - Nutrition Hôpital Raymond Poincaré, FR-Garches, France
  3. Institute of Tropical Medicine - Department of Microbiology, BE-Antwerp, Belgium
  4. St George's Hospital Medical School - Medical Microbiology, UK-London, United Kingdom
  5. London School of Hygiene and Tropical Medicine - Department of Infectious and Tropical Diseases, UK-London, United Kingdom
  6. Programme National de Lutte contre la Tuberculose, Dakar, Senegal
  7. Programme National contre la Tuberculose - Laboratoire de Référence des Mycobactéries, Cotonou, Benin
  8. South African Medical Research Council - Tuberculosis Research Lead Programme, Pretoria, South Africa
  9. Kenya Medical Research Institute - The Centre for Respiratory Diseases Research (CRDR), Kemri, Kenya

 
 
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