Onchocerciasis (river blindness) Infections and Infestations
Conditions
Interventions
The study is a prospective, stratified randomized, controlled, open-label, parallel-group, interventional phase III trial with blinded endpoint evaluation as the histologists and the persons responsib
Sponsors
University of Buea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General inclusion criteria for prevalence assessment and compliance monitoring (incl. skin biopsies, nodule palpation): 1. Age 2-3 years for prevalence assessment using antibody test otherwise age: = 5 years for all other assessments 2. Willingness to participate in the study by signing the Informed Consent Form (ICF) Participants will only be included in the study (incl. nodulectomies) if they meet all of the following criteria: 1. Age: 15-70 years 2. Presence of at least one Onchocerca nodule detected by palpation and/or OV MF-positive 3. No previous history of adverse drug reaction with tetracyclines 4. Participants with the ability to follow study instructions and are likely to attend and complete all required visits
Exclusion criteria
Exclusion criteria: General exclusion criteria: 1. Participants not able to give consent 2. Participants who are unable to understand the nature, scope, significance, and consequences of this trial 3. Simultaneous participation in any clinical trial 4. Any significant medical condition other than filarial infections, including but not limited to autoimmune disorders, chronic respiratory conditions, and any diagnosed psychological or psychiatric disorders (e.g., schizophrenia, depression, epilepsy, Parkinson’s disease, autism), which in the opinion of the study investigator or trial clinician might interfere with the conduct of the study Exclusion from DOX treatment study (treatment arm A and B): 5. Body weight 2× upper limit of normal (ULN) 16. AST (GOT) > 2× ULN 17. ALT (GPT) > 2× ULN 18. ?-GT > 2× ULN 19. Platelet count 8,000 MF/mL 23. History of serious adverse events (SAEs) to ivermectin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and percentage of participants without live female worms with normal embryogenesis (participants with dead or sterile worms only by histology plus patients who no longer have palpable nodules) 20 (-2/+4) months after treatment onset/study start. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number (%) of participants without palpable nodules 20 (-2/+4) months after study start. 2. Measurement of treatment effects on worm vitality, fertility and Wolbachia by immunohistology and qPCR after 20 (-2/+4) months. 3. Reduction/Absence of MF in the skin compared to baseline at 6, 12 and 20 (-2/+4) months after treatment onset. 4. Assessment of treatment effects on Wolbachia/MF (qPCR) at different time points; 6, 12 and 20 (-2/+4) months compared to baseline. 5. Nodule and MF prevalence in children (5-14 years) at baseline and 20 months after treatment. 6. OV16 prevalence in children (2-3 years) at baseline and in the same age group (children born after treatment start) 36 months after treatment onset. 7. Number (%) of infective vectors at baseline, 12 and 20 months after study start. 8. Monitoring the CDTi compliance before and during the study period. 9. Assessment of the perception of DOX +/- ground larviciding in a community-based approach. 10. Adverse events (AEs) as well as Serious Adverse Events (SAEs) in response to the different treatments will be assessed and described (DOX within the scope of daily observed treatment and ground larviciding in the scope of inventory of non-target fauna within the rivers diversity and abundance of non-target species in rivers before and after larviciding). | — |
Countries
Cameroon
Contacts
Public ContactSamuel Wanji
Outcome results
None listed