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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Centro per le Malattie Tropicali
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Centro per le Malattie Tropicali
ClinicalTrials.gov Identifier:
NCT01570504
First received: March 27, 2012
Last updated: August 5, 2016
Last verified: August 2016
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Patients with partial response to treatment at T 2 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]
    grade 1 to 5 as defined in detailed protocol

  • Patients with increase in blood ALT over cutoff value [ Time Frame: Day 17 ] [ Designated as safety issue: Yes ]
  • Patients with decrease in WBC count below cutoff value [ Time Frame: Day 17 ] [ Designated as safety issue: Yes ]
  • Average difference in blood ALT and WBC count at day 17, compared with baseline [ Time Frame: Day 17 ] [ Designated as safety issue: Yes ]
  • Average difference in blood eosinophil count at T2, compared with baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: March 2013
Primary Completion Date: August 2016 (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

  Eligibility

Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  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 ClinicalTrials.gov identifier: NCT01570504

Contacts
Contact: Dora Buonfrate, MD +39 045 601 3563 dora.buonfrate@sacrocuore.it

Locations
Belgium
IMTA Not yet recruiting
Antwerp, Belgium
Italy
Centro per le Malattie Tropicali, Ospedale Sacro Cuore Recruiting
Negrar, Verona, Italy, 37024
Clinica di Malattie Infettive e Tropicali Recruiting
Brescia, Italy
UFDID, Azienda Ospedaliero-universitaria Careggi Recruiting
Florence, Italy
Unità di Malattie Infettive, Anna Meyer Children's Universisty Hospital Recruiting
Florence, Italy
Reparto Malattie Infettive, Ospedale Ca' Foncello Active, not recruiting
Treviso, Italy
Peru
UPCH, Hospital Cayetano Heredia Not yet recruiting
Lima, Peru
Spain
Unidad de Medicina, Hospital de Poniente-El Ejido Recruiting
El Ejido, Almeria, Spain
Principal Investigator: Joaquin Salas Coronas         
FCRB, Hospital Clinic de Barcelona Recruiting
Barcelona, Spain
Unitat Medicina Tropical i Salut Internacional Drassanes Recruiting
Barcelona, Spain
United Kingdom
Addenbrookes Hospital, Cambridge University Hospital Active, not recruiting
Cambridge, United Kingdom
UCLH Recruiting
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
  More Information

Responsible Party: Centro per le Malattie Tropicali
ClinicalTrials.gov Identifier: NCT01570504     History of Changes
Other Study ID Numbers: CTD1-2012  2011-002784-24 
Study First Received: March 27, 2012
Last Updated: August 5, 2016
Health Authority: Italy: Ethics Committee

Keywords provided by Centro per le Malattie Tropicali:
Strongyloidiasis
Strongyloides stercoralis
Ivermectin

Additional relevant MeSH terms:
Strongyloidiasis
Rhabditida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 23, 2016