This study aims at evaluating the safety and efficacy of levamisole in patients with loiasis infection.
This clinical trial will be conducted in Republic of Congo. This is a pragmatic and adaptative randomized, double-blind clinical trial. Levamisole will be tested at 1 and 1,5 mg/kg, and compared to placebo (36:36:36); or 2,5 mg/kg compared to placebo (36:36) in case of adaptation of the dose for cohorts II and III. We will perform three cohorts of patients according to the microfilarial density : 1-1,999 mf/ml, 1-14,999 mf/ml, and all microfilaremic individuals; in order to respect the safety potentially related to loiasis. The first cohort was to evaluate the most appropriate dose of levamisole, with a possibility to increase (to 2.5 mg/kg) the dose of levamisole for the cohorts II and III in case of lack of efficacy and in case of good safety profil.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
255
A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.
A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.
A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.
Secteur opérationnelle de la Santé, Ministère de la Santé et de la Population
Sibiti, Republic of the Congo
Safety and tolerability of levamisole
Absence of severe adverse events during the first week
Time frame: 1 week
Incidence of adverse events with levamisole
Proportion of adverse events during the first week
Time frame: 1 week
Efficacy of levamisole
Proportion of reduction of the microfilarial density of Loa loa at Day 2, Day 7, and Month 1
Time frame: Day 2, Day 7, and Month 1
Proportion of individuals without microfilariae of Loa loa
Proportion of individuals with a diminution of 40% and 80% and more of the microfilarial density at Day 7 and Month 1
Time frame: Day 7 and 1 Month
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5 tablets of placebo will be administrated to the participants.