Skip to main content
OpenTrials
Completed

NCT Number: NCT01570504

Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Strongyloidiasis Helminthiasis Infections Nematode Infections Parasitic Diseases Rhabditida Infections Secernentea Infections

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro per le Malattie Tropicali, Ospedale Sacro Cuore, Negrar, Verona, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ivermectin

Drug

oral formulation

Other names: Stromectol

Primary outcomes

  1. clearance of strongyloides infection

    Time frame: 12 months

    Clearance of infection is defined by: negative stool agar/charcoal culture/RT-PCR - direct examination of three faecal samples for S. stercoralis AND negative serology or decrease in titer below a defined cutoff

Secondary outcomes

  1. All-cause mortality during the 12 months of follow-up.

    Time frame: 12 months

  2. Patients with partial response to treatment at T 2

    Time frame: 12 months

  3. Patients with adverse reactions

    Time frame: From Day 1st to Day 5th of treatment and from Day 15th to Day 19th (or 72 hours from treatment completion)

    grade 1 to 5 as defined in detailed protocol

  4. Patients with increase in blood ALT over cutoff value

    Time frame: Day 17

  5. Patients with decrease in WBC count below cutoff value

    Time frame: Day 17

  6. Average difference in blood ALT and WBC count at day 17, compared with baseline

    Time frame: Day 17

  7. Average difference in blood eosinophil count at T2, compared with baseline

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Centro per le Malattie Tropicali

Other

Collaborators

  • European Commission

Registry information

Official study title

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

Acronym: STRONGTREAT

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2012
Registry last updated
Jun 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.