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.
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
Participation in any study other than a purely observational study, within the 4 weeks preceding this study (determined by the theoretical date of the first administration of levamisole or placebo)
Any vaccination within 4 weeks previous to this study
Infection requiring treatment in the 10 days previous to this study, as determined by the anamnesis during the medical interview (e.g. pulmonary infection , digestive or skin infection; with or without antibiotic treatment)
Treatment with clozapine, phenothiazines, sulfasalazine, carbamazepine, synthetic antithyroid drugs, ticlopidine, cimetidine, and gold salts: whether it was long-term treatment, or treatment given as a single dose 10 days before the start of treatment for the clinical trial (precaution with regard to the risk of agranulocytosis of immuno-allergic or toxic origin)
Parallel
Levamisole 3 days
DrugLevamisole for 3 days (2,5 mg/kg) then placebo for 2 days
Levamisole 5 days
DrugLevamisole for 5 days (2,5 mg/kg)
Placebo
DrugPlacebo for 5 days
Tolerance of multiple doses of levamisole 2.5 mg/kg in individuals with Loa loa microfilaremia
The proportions of adverse reactions and severe adverse reactions between the three arms of study will be compared, as well as between each interventional arm versus placebo, using appropriate comparative tests A multivariate analysis may be envisaged to assess the influence of age, gender and the presence or absence of M. perstans on the proportion of AEs
Efficacy of multiple doses of levamisole 2.5 mg/kg on Loa loa microfilaremia
Microfilaremia reduction rates will be compared between arms at Day 3, Day 5, Day 7, Day 15 and Day 30. The proportions of subjects who had reduced their microfiflaremia by at least 80% at D3, D5, D7, D15 and D30 will be compared Finally, a multivariate analysis could be carried out to assess the influence of age, gender and the presence or absence of M. perstans on the reduction of the microfilaremia.
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Programme National de Lutte contre l'Onchocercose, Republic of the Congo
Lead sponsor
Institut de Recherche pour le Developpement
Collaborator
