lymphatic filariasis
Conditions
Interventions
Treatment Dox
Treatment MoxA
Treatment MDA only
Sponsors
Kumasi Centre for Collaborative Research in Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General inclusion criteria for community screening • Age = 5 years • Able and willing to give informed consent/assent Additional inclusion criteria for treatment and control groups • Age 14 – 70 years (inclusive) • LF infected person (FTS-positive)
Exclusion criteria
Exclusion criteria: Exclusion criteria for treatment and control groups • Simultaneous participation in any clinical trial • Any significant condition other than filariasis (including medical and psychological/psychiatric disorder) which in the opinion of the study investigator might interfere with the conduct of the study. Specific exclusion criteria for Group A “DOX” participants • Body weight 2 times upper limit of normal o AST (GOT) > 2 times upper limit of normal o ALT (GPT) > 2 times upper limit of normal o ?-GT > 2 times upper limit of normal o Hb < 7 g/dL o Positive urine pregnancy test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of FTS-negative individuals of all eligible participants 24 months after treatment onset. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of FTS-negative volunteers in the whole community 24 months after treatment onset 2. Proportion of FTS-negative individuals of all eligible participants 12 months post-treatment 3. Proportion of MF-negative individuals, determined by microscopy in night blood, of all eligible participants at 12 and 24 months after treatment onset 4. Change in MF loads, determined by microscopy in night blood, at 12 and 24 months in all eligible participants after treatment onset 5. Proportion of MF-negative individuals, determined by microscopy in night blood, from the FTS+ participants in the community 24 months after treatment onset 6. Change of quantitative CFA measured by Og4C3 ELISA in all eligible participants at 12 and 24 months after treatment onset 7. Proportion of eligible men without live W. bancrofti in the scrotum, determined by ultrasound examination at 12 and 24 months after treatment onset 8. Proportions of people compliant with DOX or MoxA treatment in the respective community assessed using direct CRF entries and diary cards filled by the nurses at every contact after first treatment to end of treatment 9. Proportion of community members taking MDA as reported by participating community members 24 months after treatment onset and random cross-checking of approximately 5% of the population with the MDA documentation of the national program. 10. Modelling of saved MDA rounds by administration of one-time treatment with DOX or MoxA using the collected data at V1, V2, V5, V6 11. Costs for DOX, MoxA and MDA treatment calculated for all time- points based on: a. Medication costs b. Expenses for the training of involved personnel/ health workers c. Travel and shipment costs to deliver medications to the villages d. Number of needed treatment rounds 12. 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 responsi | — |
Countries
Ghana, Tanzania
Contacts
Public ContactJubin OseiMensah
Lecturer Kwame Nkrumah University of Science and Technology
Outcome results
None listed