Evaluation of a nitric oxide generating dressing (EDX110) to improve management of Buruli ulcer disease (BURULINOX)
- Conditions
- Skin and Connective Tissue Diseases
- Registration Number
- PACTR201812819039144
- Lead Sponsor
- Kumasi Centre for Collaborative Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 142
i.Male or female patients aged between 5 years and 80 years inclusive.
ii.Buruli lesion (ulcer, nodule or plaque) 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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Time to healing of Buruli lesions within 16 weeks (EDX-RC versus VG-RC) using Kaplan–Meier analysis.<br>•Comparison of Percentage Area Reduction of Buruli lesions at various time points during the 16 weeks (8, 12 and 16 weeks)<br>
- Secondary Outcome Measures
Name Time Method •Proportion of patients in each arm who express desirable markers of the immune profile e.g. TNF?-CD40L-IFN?-CD4+ <br>•Time to no viable organisms detectable within 16 weeks (EDX-RC versus VG-RC) using Kaplan–Meier analysis. <br>•Proportion of patients who are tolerant to the dressing materials throughout treatment<br>•Comparison of the number of adverse events and serious adverse events.