NCT01570504.

Trial name or title	Multiple versus single dose of ivermectin for the treatment of strongyloidiasis (STRONGTREAT) Trial registration number (EudraCT number): 2011‐002784‐24
Methods	Randomized, open‐label, multi centre Phase III clinical trial on multiple versus single dose of ivermectin for the treatment of strongyloidiasis
Participants	Inclusion criteria: male and female patients older than 5 years and weighting > 15 kg. Current residence in non‐endemic areas. Either direct diagnosis of S. stercoralis infection and positive serology at any titre or positive serology at "high" titre, irrespective of results of direct tests. Exclusion criteria: pregnant or lactating women; subjects suffering from CNS diseases; disseminated strongyloidiasis; immunocompromised patients; lack of informed consent; previous treatment with ivermectin (in the last year).
Interventions	Experimental: ivermectin multiple doses (a dose of 200 μg/kg of ivermectin given on days 1,2, 15 and 16). Active comparator: 1 dose ivermectin (a single 200 μg/kg dose of ivermectin).
Outcomes	Primary outcome: clearance of strongyloides infection (clearance of infection is defined by negative stool agar/charcoal culture ‐ direct examination of three faecal samples for S. stercoralis and negative serology or decrease in titre below a defined cutoff. Secondary outcome: all‐cause mortality during the 12 months of follow‐up. Patients with partial response to treatment at T2. Patients with adverse reactions. Time Frame: from 1st to 5th day of treatment and from 15th to 19th day (or 72 hours from treatment completion). Patients with increase in blood ALT over cutoff value. Patients with decrease in WBC count below cutoff value. Average difference in blood ALT and WBC count at day 17, compared with baseline. Average difference in blood eosinophil count at T2, compared with baseline.
Starting date	March 2013
Contact information	Dora Buonfrate, MD (dora.buonfrate@sacrocuore.it) +39 601 3563
Notes	Funders: European Comission‐Framework VII