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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01570504
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : June 14, 2018
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Centro per le Malattie Tropicali

Study Description
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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
Strongyloidiasis Drug: Ivermectin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : March 2013
Actual Primary Completion Date : June 8, 2018
Actual Study Completion Date : June 8, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arms and Interventions
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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 Name: Stromectol
Active Comparator: 1 dose ivermectin
A single 200 mcg/kg dose of ivermectin
 Drug: Ivermectin
oral formulation
Other Name: Stromectol


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570504


Locations
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Italy
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
Spain
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
UCLH
London, United Kingdom
Sponsors and Collaborators
Centro per le Malattie Tropicali
European Commission
Investigators
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Principal Investigator: Zeno Bisoffi, MD, PhD Centre for Tropical Diseases, Negrar (Verona), Italy
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centro per le Malattie Tropicali
ClinicalTrials.gov Identifier: NCT01570504    
Other Study ID Numbers: CTD1-2012
2011-002784-24 ( EudraCT Number )
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centro per le Malattie Tropicali:
Strongyloidiasis
Strongyloides stercoralis
Ivermectin
Additional relevant MeSH terms:
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Strongyloidiasis
Rhabditida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
 Parasitic Diseases
Infections
Ivermectin
Antiparasitic Agents
Anti-Infective Agents