@article{fdi:010084754,
  title = {{S}afety and efficacy of levamisole in loiasis : a randomized, placebo-controlled, double-blind clinical trial},
  author = {{C}ampillo, {J}. {T}. and {B}ikita, {P}. and {H}emilembolo, {M}. and {L}ouya, {F}. and {M}issamou, {F}. and {P}ion, {S}{\'e}bastien and {B}oussinesq, {M}ichel and {C}hesnais, {C}.},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground {I}ndividuals with high microfilarial densities ({MFD}s) of {L}oa loa are at risk of developing serious adverse events ({SAE}s) after ivermectin treatment. {P}retreatment with drugs progressively reducing {L}oa {MFD}s below the risk threshold might help prevent these {SAE}s. {W}e assessed the safety and efficacy of levamisole for this purpose. {M}ethods {A} double-blind, randomized, placebo-controlled, {MFD}-ascending trial was conducted in the {R}epublic of the {C}ongo. {P}articipants 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). {S}afety outcomes were occurrence of {SAE} and adverse event frequency during the first week. {T}he efficacy outcomes were {MFD} reduction from baseline and proportions of individuals with at least 40% and 80% {MFD} reduction at day 2 ({D}2), {D}7, and {D}30. {R}esults {T}he 2 lowest doses (1.0mg/kg and 1.5mg/kg) caused no {SAE}s but were ineffective. {C}ompared 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 {D}2 (-12.9% vs. +15.5%, {P}<.001), {D}7 (-4.9% vs. +18.7%, {P}<.001), and {D}30 (-0.5% vs. +13.5%, {P}=.036) and a higher percentage of participants with >40% {MFD} reduction at {D}2 (17.5% vs. 1.2%, {P}<.001), {D}7 (11.8% vs. 6.3%, {P}=.269), and {D}30 (18.5% vs. 9.6%, {P}=.107). {C}onclusions {A} single 2.5mg/kg levamisole dose induces a promising transient reduction in {L}oa loa {MFD}s and should encourage testing different regimens. {S}ingle dose of levamisole (2.5mg/kg) is safe in {L}oa loa-infected subjects and reduces microfilaremia temporarily. {H}igher doses or longer regimens should be tested to evaluate whether levamisole can be used as a pretreatment to prevent post-ivermectin {L}oa-related encephalopathy.},
  keywords = {loiasis ; clinical trial ; levamisole ; filariasis ; {A}frica ; {CONGO}},
  booktitle = {},
  journal = {{C}linical {I}nfectious {D}iseases},
  volume = {[{E}arly access]},
  numero = {},
  pages = {[9 ]},
  ISSN = {1058-4838},
  year = {2022},
  DOI = {10.1093/cid/ciab906},
  URL = {https://www.documentation.ird.fr/hor/fdi:010084754},
}