title: Efficacy of Moxidectin Versus Ivermectin Against Strongyloides stercoralis Infections: A Randomized, Controlled Noninferiority Trial.
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.
  
  
  BACKGROUND
  Current Controlled Trials: ISRCTN11983645.
authors.affiliation: Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute.|University of Basel, Switzerland.
authors.forename: Beatrice
authors.initials: B
authors.lastname: Barda
authors.affiliation: National Institute of Public Health, Ministry of Health, Vientiane, Lao People's Democratic Republic.
authors.forename: Somphou
authors.initials: S
authors.lastname: Sayasone
authors.affiliation: National Institute of Public Health, Ministry of Health, Vientiane, Lao People's Democratic Republic.
authors.forename: Khampheng
authors.initials: K
authors.lastname: Phongluxa
authors.affiliation: National Institute of Public Health, Ministry of Health, Vientiane, Lao People's Democratic Republic.
authors.forename: Syda
authors.initials: S
authors.lastname: Xayavong
authors.affiliation: National Institute of Public Health, Ministry of Health, Vientiane, Lao People's Democratic Republic.
authors.forename: Khonsavanh
authors.initials: K
authors.lastname: Keoduangsy
authors.affiliation: University of Basel, Switzerland.|Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute.
authors.forename: Peter
authors.initials: P
authors.lastname: Odermatt
authors.affiliation: Department of Pharmaceutical Technology, University of Basel, Switzerland.
authors.forename: Maxim
authors.initials: M
authors.lastname: Puchkov
authors.affiliation: Department of Pharmaceutical Technology, University of Basel, Switzerland.
authors.forename: Jörg
authors.initials: J
authors.lastname: Huwyler
authors.affiliation: University of Basel, Switzerland.|Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute.
authors.forename: Jan
authors.initials: J
authors.lastname: Hattendorf
authors.affiliation: Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute.|University of Basel, Switzerland.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Keiser
mesh_terms: D000328:Adult; D000818:Animals; D000969:Antinematodal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D060085:Coinfection / Q000188:drug therapy / Q000469:parasitology; D000074099:Equivalence Trials as Topic; D005260:Female; D006801:Humans; D007559:Ivermectin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D059012:Lost to Follow-Up; D018942:Macrolides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D009855:Onchocerciasis / Q000150:complications / Q000188:drug therapy; D009891:Opisthorchis / Q000187:drug effects; D016037:Single-Blind Method; D017171:Strongyloides stercoralis / Q000187:drug effects*; D013322:Strongyloidiasis / Q000150:complications / Q000188:drug therapy*
chemical_list: D000969:Antinematodal Agents; D018942:Macrolides; D007559:Ivermectin; C027837:moxidectin
keywords: Opisthorchis viverrini; Strongyloides stercoralis; ivermectin; moxidectin