Antibiotic targeting of wolbachia endosymbiotic bacteria as a new approach to the treatment of filarial (Onchocerca Volvulus) infection and disease
- Conditions
- Onchocerciasis (river blindness)Infections and InfestationsOnchocerciasis
- Registration Number
- ISRCTN71141922
- Lead Sponsor
- European Commission (Belgium)
- Brief Summary
2008 results in: https://www.ncbi.nlm.nih.gov/pubmed/17999080 (added 09/05/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 67
All male or female subjects, aged 18-50 years, who have given informed consent (written or thumb print) were evaluated. Minimum body weight criteria is >40 kg. Participants were then included only if they met the following criteria:
1. Normal renal and hepatic laboratory profiles for aspartate aminotransferase (AST) (0-40 IU/l), alanine aminotransferase (ALT) (0-45 IU/l)
2. Creatinine 53-126 µmol/l as measured by dipstick chemistry
3. More than two palpable onchocercomas
4. Microfilarial (Mf) counts >10 Mf/mg (skin biopsies)
1. Pregnancy (pregnancy test)
2. Lactation
3. Intolerance to ivermectin or doxycycline
4. Chronic diseases
5. Alcohol or drug abuse
6. Anti-filarial therapy within the last two years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Sustained amicrofilaraemia in doxycycline- and ivermectin-treated patients compared with ivermectin-treated patients as assessed by levels of microfilaridermia in skin biopsies at 5,15 and 21 months<br> 2. Macrofilaricidal (curative) effects of doxycycline treatment as assessed by immunohistology, polymerase chain reaction (PCR) and ultrasonography at 5, 15 and 21 months<br>
- Secondary Outcome Measures
Name Time Method Reduction in adverse reaction to ivermectin treatment