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

This study is ongoing, but not recruiting participants.
European Commission
Information provided by (Responsible Party):
Centro per le Malattie Tropicali Identifier:
First received: March 27, 2012
Last updated: May 24, 2017
Last verified: May 2017

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.

Condition Intervention Phase
Strongyloidiasis Drug: Ivermectin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open-label, Multi Centre Phase III Clinical Trial on Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis

Resource links provided by NLM:

Further study details as provided by Centro per le Malattie Tropicali:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • All-cause mortality during the 12 months of follow-up. [ Time Frame: 12 months ]
  • Patients with partial response to treatment at T 2 [ Time Frame: 12 months ]
  • 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

  • Patients with increase in blood ALT over cutoff value [ Time Frame: Day 17 ]
  • Patients with decrease in WBC count below cutoff value [ Time Frame: Day 17 ]
  • Average difference in blood ALT and WBC count at day 17, compared with baseline [ Time Frame: Day 17 ]
  • Average difference in blood eosinophil count at T2, compared with baseline [ Time Frame: 12 months ]

Enrollment: 312
Actual Study Start Date: March 2013
Estimated Study Completion Date: May 30, 2018
Estimated Primary Completion Date: May 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ivermectin multiple doses
A dose of 200 mcg/kg of ivermectin given on days 1,2, 15 and 16
Drug: Ivermectin
oral formulation
Other Name: Stromectol
Active Comparator: 1 dose ivermectin
A single 200 mcg/kg dose of ivermectin
Drug: Ivermectin
oral formulation
Other Name: Stromectol


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01570504

Centro per le Malattie Tropicali, Ospedale Sacro Cuore
Negrar, Verona, Italy, 37024
Clinica di Malattie Infettive e Tropicali
Brescia, Italy
UFDID, Azienda Ospedaliero-universitaria Careggi
Florence, Italy
Unità di Malattie Infettive, Anna Meyer Children's Universisty Hospital
Florence, Italy
Unidad de Medicina, Hospital de Poniente-El Ejido
El Ejido, Almeria, Spain
FCRB, Hospital Clinic de Barcelona
Barcelona, Spain
Unitat Medicina Tropical i Salut Internacional Drassanes
Barcelona, Spain
United Kingdom
Addenbrookes Hospital, Cambridge University Hospital
Cambridge, United Kingdom
London, United Kingdom
Sponsors and Collaborators
Centro per le Malattie Tropicali
European Commission
Principal Investigator: Zeno Bisoffi, MD, PhD Centre for Tropical Diseases, Negrar (Verona), Italy
  More Information

Responsible Party: Centro per le Malattie Tropicali Identifier: NCT01570504     History of Changes
Other Study ID Numbers: CTD1-2012
2011-002784-24 ( EudraCT Number )
Study First Received: March 27, 2012
Last Updated: May 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centro per le Malattie Tropicali:
Strongyloides stercoralis

Additional relevant MeSH terms:
Rhabditida Infections
Secernentea Infections
Nematode Infections
Parasitic Diseases
Antiparasitic Agents
Anti-Infective Agents processed this record on August 18, 2017