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- Title
Safety and Efficacy of Levamisole in Loiasis: A Randomized, Placebo-controlled, Double-blind Clinical Trial.
- Authors
Campillo, Jérémy T; Bikita, Paul; Hemilembolo, Marlhand; Louya, Frédéric; Missamou, François; Pion, Sébastien D S; Boussinesq, Michel; Chesnais, CédricB
- Abstract
Background Individuals with high microfilarial densities (MFDs) of Loa loa are at risk of developing serious adverse events (SAEs) after ivermectin treatment. Pretreatment with drugs progressively reducing Loa MFDs below the risk threshold might help prevent these SAEs. We assessed the safety and efficacy of levamisole for this purpose. Methods A double-blind, randomized, placebo-controlled, MFD-ascending trial was conducted in the Republic of the Congo. Participants were treated in 3 cohorts defined by pretreatment MFD and levamisole dose (cohort 1: 1.0kg and 1.5mg/kg; cohorts 2 and 3: 2.5mg/kg). Safety outcomes were occurrence of SAE and adverse event frequency during the first week. The efficacy outcomes were MFD reduction from baseline and proportions of individuals with at least 40% and 80% MFD reduction at day 2 (D2), D7, and D30. Results The 2 lowest doses (1.0mg/kg and 1.5mg/kg) caused no SAEs but were ineffective. Compared with placebo, 2.5mg/kg levamisole caused more mild adverse events (10/85 vs. 3/85, P =.018), a higher median reduction from baseline to D2 (-12.9% vs. +15.5%, P <.001), D7 (-4.9% vs. +18.7%, P <.001), and D30 (-0.5% vs. +13.5%, P =.036) and a higher percentage of participants with >40% MFD reduction at D2 (17.5% vs. 1.2%, P <.001), D7 (11.8% vs. 6.3%, P =.269), and D30 (18.5% vs. 9.6%, P =.107). Conclusions A single 2.5mg/kg levamisole dose induces a promising transient reduction in Loa loa MFDs and should encourage testing different regimens.
- Subjects
CONGO (Brazzaville); ANTIPARASITIC agents; DRUG efficacy; IMIDAZOLES; PLACEBOS; RANDOMIZED controlled trials; COMPARATIVE studies; FILARIASIS; BLIND experiment; DESCRIPTIVE statistics; DRUG side effects; PATIENT safety; LONGITUDINAL method; EVALUATION
- Publication
Clinical Infectious Diseases, 2022, Vol 75, Issue 1, p19
- ISSN
1058-4838
- Publication type
Article
- DOI
10.1093/cid/ciab906