Onchocerciasis (river blindness) Infections and Infestations Onchocerciasis
Conditions
Interventions
100 mg/day oral doxycycline or matching placebo for 6 weeks.
Volunteers for this study are recruited, based on the inclusion and exclusion criteria, and treated directly in their villages (along the
Sponsors
European Commission (Belgium)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females between 18 - 50 years 2. Good general health without any clinical condition requiring long-term medication 3. Clinical manifestation of onchocerciasis assessed by skin biopsies and palpation (at least one onchocercoma) 4. Minimum body weight 40 kg
Exclusion criteria
Exclusion criteria: 1. Pregnancy (if not obvious all women are tested by dipstick chemistry: beta-human chorionic gonadotropin [BhCG]) 2. Currently breast-feeding 3. Evidence of clinically significant neurological, cardiac, pulmonary, hepatic, rheumatological, or renal disease by history, physical examination, and/or laboratory tests 4. Behavioural, cognitive or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study protocol 5. Laboratory evidence of liver disease (aspartate aminotransferase [AST], alanine aminotransferase [ALT] and/or gamma-glutamyl transferase (GGT) greater than 1.25 times the upper limit of normal of the testing laboratory) 6. Laboratory evidence of renal disease (serum creatinine greater than 1.25 times the upper limit of normal of the testing laboratory) 7. Other condition that, in the opinion of the investigator, would jeopardise the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol 8. Volunteer has abused alcohol or illicit drugs during the past 6 months by history 9. History of severe allergic reaction or anaphylaxis 10. Intolerance to doxycycline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of sterile or dead female O. volvulus worms in nodules from doxycycline-treated onchocerciasis patients, measured 20 months after the start of drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction or absence of microfilariae in the skin, measured 20 months after the start of drug administration | — |
Countries
Ghana
Outcome results
None listed