Skin and Connective Tissue Diseases
Conditions
Interventions
Sponsors
Kumasi Centre for Collaborative Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i. Male or female patients aged between 5 years and 80 years inclusive. ii. Buruli lesion (ulcer, nodule or plaque) </=15cm diameter, with or without associated oedema. iii. The lesion must have been tested positive for M. ulcerans by PCR for IS2404 iv. Able to give informed consent/assent for minors. v. Able and willing (or have parents/carers able and willing) to follow the protocol requirements
Exclusion criteria
Exclusion criteria: i. Female patients who are pregnant or breast-feeding. ii. Any other serious disease likely to compromise the outcome of the trial. iii. Participation in any interventional study during the 2 weeks (or 5 half-lives of the investigational product, if longer) preceding the intervention period of the study. iv. Currently taking antibiotics that could interact with the trial medication. v. Known allergy to any of the oral antibiotics or components of EDX dressing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Time to healing of Buruli lesions within 16 weeks (EDX-RC versus VG-RC) using Kaplan–Meier analysis. •Comparison of Percentage Area Reduction of Buruli lesions at various time points during the 16 weeks (8, 12 and 16 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Proportion of patients in each arm who express desirable markers of the immune profile e.g. TNF?-CD40L-IFN?-CD4+ • Time to no viable organisms detectable within 16 weeks (EDX-RC versus VG-RC) using Kaplan–Meier analysis. • Proportion of patients who are tolerant to the dressing materials throughout treatment • Comparison of the number of adverse events and serious adverse events. | — |
Countries
Ghana
Contacts
Public ContactBernadette Agbavor
KCCR
Outcome results
None listed