Wuchereria bancrofti lymphoedema stage I - V Infections and Infestations Filariasis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age range 18 - 68 years 2. Males and females 3. Diagnosed clinically to have lymphoedema stages I - V 4. Permanent residents in the study area 5. May be microfilaraemia positive or negative
Exclusion criteria
Exclusion criteria: 1. Children and pregnant women 2. Chronic liver, kidney, cardiac, central nervous system disease 3. Allergy to the trial drugs 4. Previous history of using anti-filarial drugs, e.g. ivermectin, albendazole, diethylcarbamazine 5. Past history of taking anti-geohelminthics, e.g. mebendazole, and antibiotics such as tetracycline or rifampicin in the last six months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients whose lymphoedema is reduced in size or cured 2. Proportion of acute filarial fevers and acute dermatoadenolymphangitis episodes or subclinical episodes prevented or reduced or halted during the trial period 3. Levels of CFA reduced or cleared 4. Levels of vascular endothelial growth factors (VEGFs) and pro-inflammatory immunological responses in plasma pre-post treatment in different stages of LE individuals | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The length of time taken for LE to change in size or cured or reappear again 2. The levels of anti-Wolbachia surface protein antibodies response at pre-post treatment 3. Tolerability of the anti-Wolbachia agent (antibiotic-doxycycline) (drug adverse events) | — |
Countries
Tanzania