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

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 Several small observational studies (published and unpublished) have shown that a fully oral treatment is promising.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

Conditions

• Mycobacterium Ulcerans Infection

Interventions

DRUG

Clarithromycin Extended Release

oral administration of Clarithromycin extended release

DRUG

Streptomycin intramuscular injection

daily intramuscular drug injection

Sponsors & Collaborators

• University of Groningen

  collaborator OTHER

• Faculté de Médecine P&M Curie, Paris-6 - Site Pitié-Salpêtrière, France

  collaborator UNKNOWN

• Drugs for Neglected Diseases

  collaborator OTHER

• World Alliance for Wound and Lymphoedema Care, Switzerland

  collaborator UNKNOWN

• Inserm U892/CNRS 699 bactériologie, Université CHU;Angers- IRIS France

  collaborator UNKNOWN

• Institute of Tropical Medicine, Antwerp, Belgium

  collaborator UNKNOWN

• National Buruli ulcer Control Programme, Ghana Health Service, Accra, Ghana

  collaborator UNKNOWN

• School of Med Sciences, Kwame Nkrumah Univ of Sci & Techn, Kumasi, Ghana

  collaborator UNKNOWN

• Komfo Anokye Teaching Hospital

  collaborator OTHER

• Kumasi Center for Collaborative Research into Tropical Medicine, Kumasi, Ghana

  collaborator UNKNOWN

• Plastic Surgery and Burns Centre, Korle-Bu Teaching Hospital, Accra, Ghana

  collaborator UNKNOWN

• University of Ghana

  collaborator OTHER

• Noguchi Memorial Institute of Medical Research, Accra, Ghana

  collaborator UNKNOWN

• Program Nat de Lutte contre la Lèpre et l'UB;Ulcère de Buruli, Cotonou, Benin

  collaborator UNKNOWN

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• Tjip S van der Werf, MD, PhD · University of Groningen, University Medical Centre Groningen

• Richard O Phillips, MD, PhD · Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science & Technology, Kumasi, Ghana

• Annick Chauty, MD · Pobè Health Centre, Pobè, Bénin

• Kingsley B Asiedu, MD, MPH · WHO, GBUI, Geneva, Switserland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2017-12-31

Completion

2018-01-31

Countries

• Benin
• Ghana

Study Locations