WHO Drug Study for Buruli Ulcer - Comparison of SR8 and CR8
Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
Participant gender:
Summary
This is a WHO-sponsored trial.
Combination therapy with streptomycin and rifampicin has been the standard antibiotic
treatment for M. ulcerans infection since 2004. In March 2010, a WHO Technical Advisory Group
recommended that a trial be carried out to develop a fully oral treatment for the disease.
Although the current treatment is effective, injection with streptomycin is a problem.
Several small observational studies (published and unpublished) have shown that a fully oral
treatment is promising.
This WHO sponsored study will be a randomized, controlled open label non-inferiority phase
II/III, multi-centre trial (1 centre in Benin and 4 centres in Ghana), with two parallel
treatment groups. The ultimate goal is to search for an effective alternative treatment to
the current standard WHO-recommended therapy for all forms of Buruli ulcer, which includes
injections of streptomycin with inherent logistic, operational and safety disadvantages.
Financial and material support:
1. American Leprosy Missions, USA
2. Raoul Follereau Foundation, France
3. MAP International, USA
4. Sanofi, France
5. 7th Framework Programme of the European Union: BuruliVac project (241500)
6. Aranz Medical Limited, New Zealand
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University Medical Center Groningen
Collaborators:
Drugs for Neglected Diseases Faculté de Médecine P&M Curie, Paris-6 - Site Pitié-Salpêtrière, France Inserm U892/CNRS 699 & labo bactériologie, Université et CHU d'Angers- IRIS, Angers, France Inserm U892/CNRS 699 bactériologie, Université CHU;Angers- IRIS France Institute of Tropical Medicine, Antwerp, Belgium Komfo Anokye Teaching Hospital Korle-Bu Teaching Hospital, Accra, Ghana Kumasi Center for Collaborative Research into Tropical Medicine, Kumasi, Ghana Kwame Nkrumah University of Science and Technology Ministry of Health, Benin National Buruli ulcer Control Programme, Ghana Health Service, Accra, Ghana Noguchi Memorial Institute of Medical Research, Accra, Ghana Plastic Surgery and Burns Centre, Korle-Bu Teaching Hospital, Accra, Ghana Program Nat de Lutte contre la Lèpre et l'UB;Ulcère de Buruli, Cotonou, Benin School of Med Sciences, Kwame Nkrumah Univ of Sci & Techn, Kumasi, Ghana University of Ghana University of Groningen World Alliance for Wound and Lymphoedema Care, Switzerland