Onchocerciasis Infections and Infestations
Conditions
Interventions
The anti-Wolbachia strategy is a clinically validated disease-modifying approach in onchocerciasis, with doxycycline providing established proof of concept through consistent Wolbachia depletion (>90%
Sponsors
University of Buea
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
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: 3.1. Presence of skin microfilariae confirmed by skin snip/biopsy (indicator of live female O. volvulus worms) 3.2. 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: 5.1. AST, ALT, and ?-GT =upper limit of normal (ULN) 5.2. Serum creatinine =ULN 5.3. 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.
Countries
Cameroon
Contacts
Public ContactRavi Lad
Outcome results
None listed