Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis (STRONGTREAT)

Centro per le Malattie Tropicali

Status and phase: Completed; Phase 3

Conditions: Strongyloidiasis

Treatments: Drug: Ivermectin

Study type: Interventional

Funder types: Other

Identifiers

NCT01570504

2011-002784-24 (EudraCT Number)

CTD1-2012

Details and patient eligibility

About

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.

Enrollment: 312 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

312 participants in 2 patient groups

ivermectin multiple doses

Experimental group

Description:

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

Treatment:

Drug: Ivermectin

1 dose ivermectin

Active Comparator group

Description:

A single 200 mcg/kg dose of ivermectin

Treatment:

Drug: Ivermectin