Status:
COMPLETED
BURULICO Drug Trial Study Protocol: RCT SR8/SR4+CR4, GHANA
Lead Sponsor:
University Medical Center Groningen
Conditions:
Buruli Ulcer
Mycobacterium Ulcerans
Eligibility:
All Genders
5+ years
Phase:
PHASE2
PHASE3
Brief Summary
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....
Detailed Description
Buruli ulcer disease (BUD) is caused by infection with Mycobacterium ulcerans. It usually starts as a small nodule under the skin but may progress to an ulcerative lesion; and eventually large, usuall...
Eligibility Criteria
Inclusion
- Male or female patients
- At least 5 years of age
- A clinical diagnosis of early M. ulcerans disease including:
- Nodules
- Plaques and small ulcers with or without oedema and less than or equal to 10cm in maximum diameter
- Disease duration no longer than six months
- DRB-PCR positive for M. ulcerans
Exclusion
- Treatment with macrolide or quinolone antibiotics, or antituberculous medication, or immunomodulatory drugs including corticosteroids within the previous one month.
- Current treatment with any drugs likely to interact with the study medication, e.g, anticoagulants, cyclosporin, phenytoin, oral contraceptive, and phenobarbitone.
- History of hypersensitivity to rifampicin, streptomycin and or clarithromycin.
- History or having current clinical signs of ascites, jaundice, partial or complete deafness, myasthenia gravis, renal dysfunction (known or suspected), diabetes mellitus, and immune compromise; or evidence for past or present tuberculosis.
- Pregnancy
- Inability to take oral medication or having gastrointestinal disease likely to interfere with drug absorption.
- Excessive alcohol intake.
- Any situation or condition which may compromise ability to comply with the trial procedures.
- Lack of willingness to give informed consent (and/or assent by parent/legal representative).
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00321178
Start Date
May 1 2006
End Date
February 1 2009
Last Update
June 30 2010
Active Locations (2)
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1
Agogo Hospital
Agogo, Ashanti Region, Ghana
2
Nkawie-Toaso Hospital
Nkawie, Ashanti Region, Ghana