Onchocerciasis
Conditions
Interventions
Sponsors
University of Buea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 60 years inclusive at the time of screening 2. Body weight: = 50 kg at screening 3. Confirmed infection: Presence of skin microfilariae confirmed by skin snip/biopsy (indicator of live female O. volvulus worms). At least one palpable subcutaneous Onchocerca nodule confirmed by clinical examination. 4. General health: Considered to be in good general health as determined by medical history, physical examination, and clinical judgment of the investigator. 5. Laboratory parameters: Screening laboratory results within acceptable ranges (see appendix 3), including: AST, ALT, and ?-GT = upper limit of normal (ULN). Serum creatinine = ULN. Haemoglobin (Hb) = 8 g/dL. 6. No ongoing clinical condition requiring regular medication that may interact with the trial interventions. 7. Able and willing to provide written informed consent and to comply with all trial procedures and follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women (confirmed by pregnancy test at screening). 2. Presence of Loa loa microfilaremia (confirmed by capillary blood smear), due to increased risk of severe adverse events with standard treatment. 3. Any severe or uncontrolled chronic medical condition that, in the opinion of the investigator, could interfere with trial participation or safety (e.g., significant cardiovascular, neurological, or metabolic disease). 4. Current use of medications known to interact with fusidic acid or doxycycline, or that could confound safety assessments – see section 7.8.1 for prohibited concomitant therapies. 5. Known hypersensitivity to fusidic acid, doxycycline, or any excipients of the trial interventions. 6. Participation in another clinical trial of an investigational product within 30 days prior to screening or during the study period. 7. Inability or unwillingness to comply with the contraceptive requirements of the trial (see Appendix 3 for the requirements). 8. Inability or unwillingness to provide written informed consent, or inability to understand the nature, scope, and potential consequences of the trial. 9. Any other condition or circumstance that, in the opinion of the investigator, may compromise the participant’s safety, the validity of the trial results, or their ability to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy (difference in percentage of live female adult worms without Wolbachia at 6 months) of each of four different fusidic acid (FA) regimens, compared to no treatment, in participants with confirmed Onchocerca volvulus infection who are alive and have at least one live female adult worm at 6 months follow-up.;To evaluate the efficacy of combination of 14 days FA (0.75 g twice daily) plus 3 days Albendazole (D1-3, 400mg once daily) compared to no treatment in participants with confirmed Onchocerca volvulus infection who are alive and have at least one female adult worm at 6 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of a combination of 14 days FA (0.75g twice daily) plus 3 days Albendazole (D1-3, 400mg once daily) compared to Albendazole in participants with confirmed Onchocerca volvulus infection who are alive and have at least one female adult worm at 6 months follow-up. ;To compare Wolbachia depletion in nodules at 6 months using PCR for each of four different fusidic acid (FA) regimens, to no treatment, in participants with confirmed Onchocerca volvulus infection who are alive and have at least one evaluable nodule at 6 months follow-up ;To compare embryogenesis based on immunohistology at 6 months, for each of four different fusidic acid (FA) regimens, to no treatment, in evaluable live adult female worms. ;To compare free microfilariae in nodules based on immunohistology at 6 months, for each of four different fusidic acid (FA) regimens, to no treatment. ;To summarise Onchocerca mf in the skin 3 and 6 months, within each arm. ;To summarise worm mortality at 6 months, in each study arm;To summarise Wolbachia clearance, in participants in each arm ;To summarise Wolbachia in the skin Onchocerca mf using PCR at baseline, 3 and 6 months, within each arm. ;To analyse the safety profile of study treatment regimens. ;Exploratory - To understand the acceptability of alternative treatment regimens from the perspective of patients and providers.;Exploratory Outcome - To explore broader health and wellbeing outcomes of alternative treatment regimens. ;To evaluate the efficacy of Albendazole compared to no treatment in participants with confirmed Onchocerca volvulus infection who are alive and have at least one female adult worm at 6 months follow-up ;To evaluate the efficacy of Doxycycline compared to no treatment in participants with confirmed Onchocerca volvulus infection who are alive and have at least one female adult worm at 6 months follow-up | — |
Countries
Cameroon
Contacts
Public ContactRavi Lad
Trial Manager
Outcome results
None listed