CompletedPhase 2/3

WHO Drug Study for Buruli Ulcer - Comparison of SR8 and CR8

Benin, Ghana310 participantsStarted 2012-12

Plain-language 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 Several small observational studies (published and unpublished) have shown that a fully oral treatment is promising.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

Who can participate

Age range5 Years

SexALL

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Exclusion criteria

✕. Patients with lesion sizes \>10cm in cross-sectional diameter
✕. Children \< 5 years, or \< 20 kilograms body weight
✕. Pregnancy (self-reported, clinically diagnosed, or urine test (beta-hCG) positive
✕. Patients with previous treatment of Buruli ulcer, tuberculosis or leprosy with at least one of the study drugs (rifampicin, streptomycin, clarithromycin)
✕. Patients with history of hypersensitivity to rifampicin and/or streptomycin and/or clarithromycin
✕. Patients with previous treatment with macrolide or quinolone antibiotics, or antituberculosis medication, or immuno-modulatory drugs including corticosteroids within one month
✕. Patients with current treatment with any drugs likely to interact with the study medication, e.g, anticoagulants, cyclosporin, phenytoin, and phenobarbitone. Users of oral contraceptives should be notified that such contraceptive is less reliable if taken with rifampicin; alternative (mechanical) contraceptive methods will be discussed with the study participant
✕. Patients with co-infection with HIV

What they're measuring

healing without recurrence and without excision surgery

Timeframe: 12 months after start of treatment

Trial details

NCT IDNCT01659437

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12

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