Lymphatic filariasis (Wuchereria bancrofti) Infections and Infestations Filariasis
Conditions
Interventions
Study drugs and treatment regimens:
1. 200 mg/day doxycycline for 6 weeks
2. 1000 mg/day amoxicillin for 6 weeks
3. Placebo for 6 weeks
Contact details for Joint Principal Investigators:
Professor O
Sponsors
Volkswagen Foundation (VolkswagenStiftung) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged between 18 - 60 years 2. Resident in the village for five years or more 3. Clinical stage of lymphoedema (1 - 5) of at least one extremity 4. Good general health without any clinical condition requiring long-term medication 5. Minimum body weight 40 kg
Exclusion criteria
Exclusion criteria: 1. Pregnancy (if not obvious all women are tested by dipstick chemistry: beta-human chorionic gonadotrophin [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 or amoxicillin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of the stage of lymphoedema and number of acute attacks, measured pre-treatment as well as 3 months, 12 months and 24 months after the start of drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction in circulating filarial antigen levels as a measure of a macrofilaricidal effect of doxycycline 2. Change in systemic immune responses All measured pre-treatment as well as 3 months, 12 months and 24 months after the start of drug administration. | — |
Countries
Ghana
Outcome results
None listed