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<p>Individuals with high <i>Loa loa</i> microfilarial densities (MFD) risk serious adverse events (SAEs) following ivermectin treatment. A single dose of levamisole (LEV) induces a temporary, progressive MFD decrease. This double-blind, randomized, placebo-controlled trial evaluated the safety and efficacy of 3-day and 5-day LEV regimens for the treatment of loiasis in the Republic of the Congo. Participants were randomly assigned to receive placebo (PLA), LEV-3, or LEV-5. Safety was assessed by the occurrence of SAEs and the frequency and severity of AEs. Efficacy was measured by changes in <i>Loa loa</i> MFD. No SAEs were reported, and AE severity was comparable across treatment arms. On day 5, MFD reductions were greater in the LEV-3 and LEV-5 groups compared to PLA ( −1.6%, 29.3%, and 51.4%, respectively; <i>P</i> &lt; 0.001). By day 7, a higher proportion of participants achieved ≥40% MFD reduction in the LEV-5 group (44.4%) compared to LEV-3 (34.6%) and PLA (8.3%) (<i>P</i> = 0.051). Post hoc contrasts confirmed significantly greater MFD reduction with LEV-5 versus LEV-3. These findings suggest that a 5-day LEV regimen is safe and moderately effective for reducing <i>L. loa</i> MFD and may represent a promising alternative for individualised management in loiasis-endemic areas, particularly where onchocerciasis is hypoendemic and coendemic with loiasis. Trial registration: NCT06252961.</p>

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Safety and efficacy of 3- and 5-day regimens of levamisole in loiasis: a randomized, placebo-controlled, double-blind clinical trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月4日

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  • Cédric B. Chesnais,
  • Marlhand C. Hemilembolo,
  • Bachiratou A. Sahm,
  • Florentin Toutin,
  • Ericson Djeutassong,
  • Nadia Nga-Elomo,
  • Benjamin Cuer,
  • Mas A. Ntsiba-N’Goulou,
  • Miveck Pakat,
  • Sébastien D. S. Pion,
  • François Missamou,
  • Michel Boussinesq,
  • Jérémy T. Campillo

摘要

Individuals with high Loa loa microfilarial densities (MFD) risk serious adverse events (SAEs) following ivermectin treatment. A single dose of levamisole (LEV) induces a temporary, progressive MFD decrease. This double-blind, randomized, placebo-controlled trial evaluated the safety and efficacy of 3-day and 5-day LEV regimens for the treatment of loiasis in the Republic of the Congo. Participants were randomly assigned to receive placebo (PLA), LEV-3, or LEV-5. Safety was assessed by the occurrence of SAEs and the frequency and severity of AEs. Efficacy was measured by changes in Loa loa MFD. No SAEs were reported, and AE severity was comparable across treatment arms. On day 5, MFD reductions were greater in the LEV-3 and LEV-5 groups compared to PLA ( −1.6%, 29.3%, and 51.4%, respectively; P < 0.001). By day 7, a higher proportion of participants achieved ≥40% MFD reduction in the LEV-5 group (44.4%) compared to LEV-3 (34.6%) and PLA (8.3%) (P = 0.051). Post hoc contrasts confirmed significantly greater MFD reduction with LEV-5 versus LEV-3. These findings suggest that a 5-day LEV regimen is safe and moderately effective for reducing L. loa MFD and may represent a promising alternative for individualised management in loiasis-endemic areas, particularly where onchocerciasis is hypoendemic and coendemic with loiasis. Trial registration: NCT06252961.