Clincosm LogoSign in Get a demo

STRONGTREAT: Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis

Sponsor
Centro per le Malattie Tropicali (Other)
Overall Status
Completed
CT.gov ID
NCT01570504
Collaborator
European Commission (Other)
312
Enrollment
9
Locations
2
Arms
63.2
Actual Duration (Months)
34.7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
312 participants
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
Actual Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Jun 8, 2018
Actual Study Completion Date :
Jun 8, 2018

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Stromectol

    		•
    Active Comparator: 1 dose ivermectin

    A single 200 mcg/kg dose of ivermectin

    Drug: Ivermectin
    oral formulation
    Other Names:
  • Stromectol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. clearance of strongyloides infection [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

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

    2. Patients with partial response to treatment at T 2 [12 months]

    3. Patients with adverse reactions [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 [Day 17]

    5. Patients with decrease in WBC count below cutoff value [Day 17]

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

    7. Average difference in blood eosinophil count at T2, compared with baseline [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 Centro per le Malattie Tropicali, Ospedale Sacro Cuore Negrar Verona Italy 37024
    2 Clinica di Malattie Infettive e Tropicali Brescia Italy
    3 UFDID, Azienda Ospedaliero-universitaria Careggi Florence Italy
    4 Unità di Malattie Infettive, Anna Meyer Children's Universisty Hospital Florence Italy
    5 Unidad de Medicina, Hospital de Poniente-El Ejido El Ejido Almeria Spain
    6 FCRB, Hospital Clinic de Barcelona Barcelona Spain
    7 Unitat Medicina Tropical i Salut Internacional Drassanes Barcelona Spain
    8 Addenbrookes Hospital, Cambridge University Hospital Cambridge United Kingdom
    9 UCLH London United Kingdom

    Sponsors and Collaborators

    • Centro per le Malattie Tropicali
    • European Commission

    Investigators

    • Principal Investigator: Zeno Bisoffi, MD, PhD, Centre for Tropical Diseases, Negrar (Verona), Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centro per le Malattie Tropicali
    ClinicalTrials.gov Identifier:
    NCT01570504
    Other Study ID Numbers:
    • CTD1-2012
    • 2011-002784-24
    First Posted:
    Apr 4, 2012
    Last Update Posted:
    Jun 14, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Centro per le Malattie Tropicali
    Strongyloidiasis
    Strongyloides stercoralis
    Ivermectin
    Additional relevant MeSH terms:
    Strongyloidiasis
    Ivermectin

    Study Results

    No Results Posted as of Jun 14, 2018