Lymphatic filariasis (LF) Infections and Infestations
Conditions
Interventions
Current interventions as of 14/03/2025:
The study involves treatment according to the area the participant is living in:
1. DOX 100: doxycycline 100 mg/d for 5 weeks (100 mg tablet/day orally), on top
ivermectin 200 mcg/kg plus albendazole 400 mg single dose
Participants in this group will receive IVM + ALB (“IA”) at baseline in parallel to the treatments in groups A and B and again after 12 month
Sponsors
Kumasi Centre for Collaborative Research in Tropical Medicine
National Institute for Medical Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =5 years 2. LF-infected person (CFA positive) 3. Able and willing to give informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 14/03/2025: Specific exclusion criteria for DOX 100 participants: 1. Age 70 years 2. Body weight 70 years 2. Body weight 70 years 2. Pregnant or breastfeeding wome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of CFA-negative individuals, measured by Filariasis Test Strip (FTS) test, among the eligible participants at 24 months after treatment onset | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 14/03/2025: 1. Endpoints on an individual level (eligible participants): 1.1. Proportion of participants with FTS score reduction compared to baseline at 12 and 24 months after treatment onset. 1.2. Proportion of FTS-negative individuals at 12 months after treatment onset. 1.3. Change of quantitative CFA measured by Og4C3 ELISA in all eligible participants at 12 and 24 months after treatment onset 1.4. Proportion of MF-negative individuals, determined by microscopy in night blood, at 12 and 24 months after treatment onset (Participants who are MF-positive at 12 months and receive an additional round of IA or MoxA will be analyzed as treatment failures at 24 months even if they become negative after the second treatment) 1.5. Change in MF loads, determined by microscopy in night blood, at 12 and 24 months after treatment onset 1.6. Proportions of eligible men with or without live W. bancrofti in the scrotum (filarial dance sign), determined by ultrasound examination at 24 months after treatment onset 1.7. Changes in levels of biomarkers, e.g., VEGF, CEACAM, MMPs, miRNA, NATOG or metabolites in blood and/or urine that could be responsible for differences in disease development and/or drug responsiveness, measured using flow-cytometry or PCR at V2, V5 and V6 1.8. Adverse events (AE) will be assessed for “MoxA”, “DOX” and “IA” as described below: 1.8.1. Occurrence of AE 1.8.2. Intensity of AE (Grade 0 (none), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) 1.8.3. Serious Adverse Events 1.8.4. Relation to treatment (definite, probable, possible, remote, not related) 1.8.5. Outcome of AE (restored, improved, unchanged, deteriorated, death, unknown, overcome with sequelae) 1.8.6. Intervention 1.9. In Ghana only: Changes in the microbiome from stool analysis before and after treatment and between people with differences in disease development and/ or drug responsiveness. 2. Endpoints on community level: 2.1. Proportion of FTS- | — |
Countries
Ghana, Tanzania
Contacts
Public ContactAlexander Yaw;Akili Debrah;Kalinga
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Outcome results
None listed