Onchocerciasis (river blindness) Infections and Infestations Onchocerciasis
Conditions
Interventions
200 mg/day Oral doxycycline or matching placebo for six weeks versus four weeks
150 mg/kg oral single dose ivermectin or matching placebo four months post-commencement of doxycycline treatment.
Added as of 13/04/2007:
200 was an erroneous copy-pas
Sponsors
European Commission (Belgium)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 2. Macrofilaricidal (curative) effects of doxycycline treatment as assessed by immunohistology, polymerase chain reaction (PCR) and ultrasonography at 5, 15 and 21 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in adverse reaction to ivermectin treatment | — |
Countries
Ghana
Outcome results
None listed