Beatrice Barda1,2, Somphou Sayasone3, Khampheng Phongluxa3, Syda Xayavong3, Khonsavanh Keoduangsy3, Peter Odermatt2,4, Maxim Puchkov5, Jörg Huwyler5, Jan Hattendorf2,4, Jennifer Keiser1,2. 1. Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute. 2. University of Basel, Switzerland. 3. National Institute of Public Health, Ministry of Health, Vientiane, Lao People's Democratic Republic. 4. Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute. 5. Department of Pharmaceutical Technology, University of Basel, Switzerland.
Abstract
BACKGROUND: Infections with Strongyloides stercoralis are of considerable public health relevance. Moxidectin, a well-established drug in veterinary medicine under consideration for regulatory submission for the treatment of onchocerciasis, might serve as an alternative to the widely used ivermectin. METHODS: We conducted an exploratory, randomized, single-blind trial to evaluate the efficacy and safety of moxidectin (8 mg) vs ivermectin (200 μg/kg) against S. stercoralis infections. Cure rate (CR) against S. stercoralis was the primary outcome. Safety and efficacy against coinfections with soil-transmitted helminths and Opisthorchis viverrini were secondary outcomes. Noninferiority required the lower limit of the 95% confidence interval (CI) of the differences in CRs not exceed 7 percentage points. RESULTS: A total of 127 participants were enrolled and randomly assigned to the 2 treatments whereby 1 participant per arm was lost to follow-up. We observed a CR of 93.7% (59/63) for moxidectin compared to 95.2% (59/62) for ivermectin. Differences between CRs were estimated as -1.5% percentage points (95% CI, -9.6 to 6.5), thus the lower limit of the CI exceeds the noninferiority margin of 7 percentage points. No side effects were observed. CRs against hookworm infection were 57% (moxidectin) and 56% (ivermectin). Low efficacy for both drugs against O. viverrini was observed. CONCLUSIONS: Moxidectin might be a safe and efficacious alternative to ivermectin for the treatment of S. stercoralis infection, given that only slight differences in CRs were observed. However, noninferiority could not be demonstrated. Larger clinical trials should be conducted once the drug is marketed. CLINICAL TRIALS REGISTRATION: Current Controlled Trials: ISRCTN11983645.
BACKGROUND: Infections with Strongyloides stercoralis are of considerable public health relevance. Moxidectin, a well-established drug in veterinary medicine under consideration for regulatory submission for the treatment of onchocerciasis, might serve as an alternative to the widely used ivermectin. METHODS: We conducted an exploratory, randomized, single-blind trial to evaluate the efficacy and safety of moxidectin (8 mg) vs ivermectin (200 μg/kg) against S. stercoralis infections. Cure rate (CR) against S. stercoralis was the primary outcome. Safety and efficacy against coinfections with soil-transmitted helminths and Opisthorchis viverrini were secondary outcomes. Noninferiority required the lower limit of the 95% confidence interval (CI) of the differences in CRs not exceed 7 percentage points. RESULTS: A total of 127 participants were enrolled and randomly assigned to the 2 treatments whereby 1 participant per arm was lost to follow-up. We observed a CR of 93.7% (59/63) for moxidectin compared to 95.2% (59/62) for ivermectin. Differences between CRs were estimated as -1.5% percentage points (95% CI, -9.6 to 6.5), thus the lower limit of the CI exceeds the noninferiority margin of 7 percentage points. No side effects were observed. CRs against hookworm infection were 57% (moxidectin) and 56% (ivermectin). Low efficacy for both drugs against O. viverrini was observed. CONCLUSIONS: Moxidectin might be a safe and efficacious alternative to ivermectin for the treatment of S. stercoralis infection, given that only slight differences in CRs were observed. However, noninferiority could not be demonstrated. Larger clinical trials should be conducted once the drug is marketed. CLINICAL TRIALS REGISTRATION: Current Controlled Trials: ISRCTN11983645.
Authors: Walter Basso; Barbara Hinney; Maria Sophia Unterköfler; Iris Eipeldauer; Sophie Merz; Nikola Pantchev; Josef Hermann; René Brunthaler Journal: Parasit Vectors Date: 2022-05-15 Impact factor: 4.047
Authors: Michael Marks; Sarah Gwyn; Hilary Toloka; Christian Kositz; James Asugeni; Rowena Asugeni; Jason Diau; John M Kaldor; Lucia Romani; Michelle Redman-MacLaren; David MacLaren; Anthony W Solomon; David C W Mabey; Andrew C Steer; Diana Martin Journal: Clin Infect Dis Date: 2020-12-15 Impact factor: 9.079
Authors: Didier Bakajika; Eric M Kanza; Nicholas O Opoku; Hayford M Howard; Germain L Mambandu; Amos Nyathirombo; Maurice M Nigo; Kambale Kasonia Kennedy; Safari L Masembe; Mupenzi Mumbere; Kambale Kataliko; Kpehe M Bolay; Simon K Attah; George Olipoh; Sampson Asare; Michel Vaillant; Christine M Halleux; Annette C Kuesel Journal: PLoS Negl Trop Dis Date: 2022-04-27