Trial | NCT01570504  Report issue

Title

Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis
Randomized, Open-label, Multi Centre Phase III Clinical Trial on Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ivermectin ...

  • Study Participants

    312
Ivermectin is currently the best drug to cure strongyloidiasis, but the "standard" single dose of 200 mcg/kg is probably not enough to guarantee cure. As strongyloidiasis can be fatal in immunosuppressed patients, it is mandatory to define the optimal dosage to eradicate the parasite.

Aim of this study is to define the most effective dose schedule of ivermectin to cure strongyloidiasis.
Study Started
Mar 31
2013
Primary Completion
Jun 08
2018
Study Completion
Jun 08
2018
Last Update
Jun 14
2018

Drug Ivermectin

oral formulation

  • Other names: Stromectol

ivermectin multiple doses Experimental

A dose of 200 mcg/kg of ivermectin given on days 1,2, 15 and 16

1 dose ivermectin Active Comparator

A single 200 mcg/kg dose of ivermectin

Criteria 

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 titer OR positive serology at "high" titer, 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)
No Results Posted