Randomized non-inferiority clinical trial to evaluate the efficacy of a single fixed dose of 18 mg ivermectin for the treatment of uncomplicated strongyloidiasis

INTERVENTION: Product Name: Ivermectin Pharmaceutical Form: Tablet CONDITION: Strongyloidiasis is caused by a parasite that is globally distributed in tropical and sub‐tropical areas. Most patients with strongyloidiasis are asymptomatic or have mild symptoms with gastrointestinal disturbances, respiratory symptoms, and skin lesions. In situations of low defenses (patients under treatment with corticosteroids, organ transplant recipients or other situations) they can present serious complications with high mortality. ; MedDRA version: 20.0 Level: PT Classification code 10042254 Term: Strongyloidiasis System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Parasitic Diseases [C03] PRIMARY OUTCOME: Main Objective: To assess the efficacy in terms of microbiological cure and safety of 18 mg single fixed dose ivermectin for the treatment of uncomplicated strongyloidiasis in immunocompetent adults compared to weight‐adjusted single dose ivermectin. Primary end point(s): Proportion of patients with microbiological cure at 6 months of treatment Secondary Objective: ‐To assess the safety, tolerability and acceptability of the two dosages of ivermectin in adult patients with uncomplicated strongyloidiasis.; ‐To evaluate the usefulness of the LAMP of S. stercoralis in stool and urine samples as a tool in the diagnosis and follow‐up after treatment of uncomplicated strongyloidiasis.; ‐To know the population pharmacokinetics of ivermectin in a single and fixed dose of 18 mg for the treatment of uncomplicated strongyloidiasis in adult patients. Timepoint(s) of evaluation of this end point: At 6 months of treatment SECONDARY OUTCOME: Secondary end point(s): ‐Evaluate the safety, tolerability of the treatment; ‐Evaluate the diagnostic tests for the detection of uncomplicated strongyloidiasis.; ‐To know the population pharmacokinetics of ivermectin Timepoint(s) of evaluation of this end point: At 6 months of treatment INCLUSION CRITERIA: ‐Age equal to or greater than 18 years. ‐Signature of the informed consent. ‐Diagnosis of strongyloidiasis either by direct parasitological methods (detection of larvae in coproparasitology or in the specific Strongyloides culture) or by positivity of a serological technique (ELISA) with an optical density inde X(OD) greater than or equal to 2. ‐Current residence in an area with no evidence of active transmission of strongyloidiasis. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 221 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 55