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.
- 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
- Write up a complete protocol to undertake a clinical trial allowing the
above mentioned objectives to be met.
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
- 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
- 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.
- 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.
- 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
- Write up the protocol complete with the budget and submit it to the Pilot
Committee for UICTMR’s clinical trials.
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
Union Internationale Contre la Tuberculose et les Maladies respiratoires
Bd. Saint Michel 68
75006 Paris, France
Tel: +33 1 44 32 03 71
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