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COCONUTKIT
TUBERCULOSIS (INCO)
Framework programme: 5
Project number:
ICA1-CT-2002-50002
EC contribution: € 90 000
Duration: 4 months
Type: AM
Starting date: 1 August 2002
Graphic element Project to coordinate the write up of a protocol for a clinical trial aimed at shortening treatment for tuberculosis

Summary:

The treatment of tuberculosis currently requires a minimum of six months of chemotherapy. Reducing this duration to four months would improve patient compliance and would consequently reduce transmission of tuberculosis in the community. This could be made possible if another drug, most probably a fluoroquinolone, was added to the current regimen. This proposal is about setting up a project for a clinical trial to test this hypothesis, with scientific teams from Europe and Africa working closely together.

Objectives:

  • Reduce the treatment time for tuberculosis to 4 months (it currently runs at 6 to 8 months) so as to facilitate the adherence of the sick to the treatment and thus lessen the transmission of the infection within the community.
  • Develop and reinforce  the international Europe
  • Africa network to make therapeutic trials in the field of tuberculosis.
  • Identify the health centres that participate in this clinical research in Africa.
  • Write up a complete protocol to undertake a clinical trial allowing the above mentioned objectives to be met.

Description:

The project consists of the writing of a protocol for a  clinical trial for treatment of tuberculosis. This write up will associate European and African teams. The clinical trial will include three legs: 2 to test the 4 month regimes, the third being a therapeutic protocol on known efficiency. It will be necessary to:

  1. Identify which molecule (most likely a fluoroquinolone) would be the most interesting to add to the actual treatment to shorten it from 6 to 4 months.
  2. Identify and contact the European teams that will participate in this clinical trial. The British Medical Council which is already a partner of UICTMR within the framework of a separate clinical trial will be solicited. Another European team will be contacted to cover the laboratory angle.
  3. Identify and contact the African teams that will participate in this clinical trial, identify the centres where the study will take place. The identification criteria are the following: have a national programme on the fight against tuberculosis which respects international directives, have a performing biological laboratory capable of realising cultures and sensibility tests, be able to recruit sufficient afflicted people to end the inclusion within one year, not to include more than 200 patients per centre so that the workload remains bearable, not to include too many countries so that supervision at national and international level remains profitable, have if possible already participated in this kind of work.
  4. Organise 2 meetings, one in Paris, the other in Africa so as to involve all the teams right from the start of the protocol write up and up to its completion.
  5. Write up the protocol complete with the budget and submit it to the Pilot Committee for UICTMR’s clinical trials.

 

Milestones:

Tuberculosis has been identified by the European Commission as a priority sickness linked to poverty. Reduction of the chemotherapy period is essential and necessary to improve the adherence  of the patient to the treatment and therefore lower the propogation of the illness in the community. The development of a platform to undertake clinical trials is one of the objectives flagshipped in the domain “Confirming the  international role of community research”

Coordinator:

Arnaud Trebucq
Union Internationale Contre la Tuberculose et les Maladies respiratoires
Bd. Saint Michel 68
75006 Paris, France
Tel: +33 1 44 32 03 71
Fax: +33 1 43 29 90 87
E-mail: atrebucq@compuserve.com

 
 
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