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Sponsored by: |
University Medical Centre Groningen |
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Information provided by: | University Medical Centre Groningen |
ClinicalTrials.gov Identifier: | NCT00321178 |
The standard for treatment Buruli ulcer disease (BUD) used to be surgery but the WHO now advises streptomycin (S, 15 mg/kg daily, intramuscularly) and rifampicin (R,10 mg/kg daily) along with surgery. This preliminary advice was based on observations in 21 patients with pre-ulcerative lesions of BUD, who were given daily SR treatment for varying periods of time. In patients treated with SR for at least 4 weeks, M. ulcerans could no longer be cultured from excised lesions. SR has been introduced without a formal evaluation or comparison with other treatments have been conducted or published, but the impression is that this treatment is beneficial and may cure BUD without additional surgical management.
This study protocol evaluates the hypothesis that early, limited lesions of BUD(pre-ulcerative or ulcerated lesions, ≤ 10 cm maximum diameter), can be healed without recurrence using antimycobacterial drug therapy, without the need for debridement surgery.
In endemic regions in Ghana, patients will be actively recruited and followed if ≥ 5 years of age, and with early (i.e., onset < 6 months) BUD.
Biopsies will be processed for histopathology, DRB-PCR-, microscopy, culture, genomic, and sensitivity tests. Lesions will be assessed regularly for progression or healing during treatment. Drug toxicity monitoring includes blood cell counts, liver enzymes and renal tests; and ECG and audiographic tests. Primary endpoint: healing without recurrence at 12 months follow-up after start of treatment Secondary endpoint: reduction in lesion surface area and/or clinically assessed improvement on completion of treatment, averting the need for debridement surgery.
Recurrences will be biopsied for confirmation, using PCR, histopathology, and culture. Sample size: 200 patients, with 2x74 evaluable patients to be randomized; 80% power to detect a difference of 20 % in recurrence-free cure 12 months after start of treatment between the two groups (60 versus 80%). A Data Safety and Monitoring Board will make interim analyses.
Condition | Intervention | Phase |
---|---|---|
Buruli Ulcer Mycobacterium Ulcerans |
Drug: SR4 - switch to CR4 |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomised Trial for Early Lesions Caused by M. Ulcerans - Comparison Between 8 Weeks Streptomycin and Rifampicin (SR), or 4 Weeks SR Followed by 4 Weeks R Plus Clarithromycin |
Enrollment: | 151 |
Study Start Date: | May 2006 |
Study Completion Date: | February 2009 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SR4/CR4: Experimental
after 4 weeks of standard treatment with streptomycin and rifampicin, patients in the experimental arm switch to oral treatment consisting of rifampicin and clarithromycin
|
Drug: SR4 - switch to CR4
switch to oral treatment after 4 weeks SR 'standard' therapy
|
SR8: Active Comparator
standard treatment consisting of 8 weeks of streptomycin and rifampicin
|
Drug: SR4 - switch to CR4
switch to oral treatment after 4 weeks SR 'standard' therapy
|
Ages Eligible for Study: | 5 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A clinical diagnosis of early M. ulcerans disease including:
Exclusion Criteria:
Ghana, Ashanti Region | |
Nkawie-Toaso Hospital | |
Nkawie, Ashanti Region, Ghana | |
Agogo Hospital | |
Agogo, Ashanti Region, Ghana |
Principal Investigator: | Tjip S van der Werf, MD PhD | University Medical Centre Groningen, University of Groningen, the Netherlands |
Responsible Party: | UMCG, University of Groningen, the Netherlands ( Prof TS van der Werf ) |
Study ID Numbers: | BURULICODRUGTRIAL, EU FP6 2003-INCO-Dev2-015476 |
Study First Received: | May 2, 2006 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00321178 History of Changes |
Health Authority: | Ghana: Ministry of Health |
Mycobacterium ulcerans Buruli ulcer Ghana randomized comparison |
streptomycin rifampicin clarithromycin |
Bacterial Infections Anti-Bacterial Agents Rifampin Clarithromycin Gram-Positive Bacterial Infections Skin Diseases |
Buruli Ulcer Ulcer Mycobacterium Infections Streptomycin Skin Ulcer Mycobacterium Infections, Atypical |
Bacterial Infections Anti-Infective Agents Skin Diseases Molecular Mechanisms of Pharmacological Action Buruli Ulcer Enzyme Inhibitors Streptomycin Pharmacologic Actions Actinomycetales Infections |
Mycobacterium Infections, Atypical Anti-Bacterial Agents Clarithromycin Protein Synthesis Inhibitors Gram-Positive Bacterial Infections Therapeutic Uses Mycobacterium Infections Skin Ulcer |