Randomized, Double-blind Trial Evaluating the Safety and Efficacy of a 3- or 5- Day Course of Levamisole 2.5 mg/kg in Subjects With Loa Loa Microfilaremia
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The aim of the study is to evaluate the safety and efficacy of a 3- and 5-day course of levamisole (2.5 mg/kg) in management of loiasis microfilaremia.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Consent informed, written, signed and dated
• Women or men aged 18 to 65 years inclusive
• Carrier of L. loa microfilaremia
• Body weight ≥ 40 kg in women and ≥ 45 kg in men; and less than 90 kg
• In good health, as determined by medical questionnaire and general clinical examination
• Absence of acute or chronic infection :
Locations
Other Locations
Republic of the Congo
General Supervisor
RECRUITING
Sibiti
Supervisor
RECRUITING
Sibiti
Contact Information
Primary
Jéremy CAMPILLO, PharmD PhD
jeremy.campillo@ird.fr
+33 4 67 41 61 52
Backup
Bachiratou SAHM
bachiratou.sahm@ird.fr
Time Frame
Start Date: 2024-06-21
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 99
Treatments
Experimental: Levamisole 3 days
Participants randomized in this arm will receive 3 days of levamisole 2.5mg/kg, followed by 2 days of placebo
Experimental: Levamisole 5 days
Participants randomized in this arm will receive a 5-day course of levamisole 2.5mg/kg
Placebo_comparator: Placebo
Participants randomized in this arm will receive 5 days of placebo
Related Therapeutic Areas
Sponsors
Leads: Programme National de Lutte contre l'Onchocercose, Republic of the Congo
Collaborators: Institut de Recherche pour le Developpement