Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis
NCT ID: NCT01570504
Last Updated: 2018-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
312 participants
INTERVENTIONAL
2013-03-31
2018-06-08
Brief Summary
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Aim of this study is to define the most effective dose schedule of ivermectin to cure strongyloidiasis.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ivermectin multiple doses
A dose of 200 mcg/kg of ivermectin given on days 1,2, 15 and 16
Ivermectin
oral formulation
1 dose ivermectin
A single 200 mcg/kg dose of ivermectin
Ivermectin
oral formulation
Interventions
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Ivermectin
oral formulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Subjects suffering from CNS diseases
* Disseminated strongyloidiasis
* Immunocompromised patients.
* Lack of informed consent
* Previous treatment with ivermectin (in the last year)
6 Years
ALL
No
Sponsors
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European Commission
OTHER
Centro per le Malattie Tropicali
OTHER
Responsible Party
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Principal Investigators
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Zeno Bisoffi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Tropical Diseases, Negrar (Verona), Italy
Locations
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Centro per le Malattie Tropicali, Ospedale Sacro Cuore
Negrar, Verona, Italy
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
Addenbrookes Hospital, Cambridge University Hospital
Cambridge, , United Kingdom
UCLH
London, , United Kingdom
Countries
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References
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Buonfrate D, Salas-Coronas J, Munoz J, Maruri BT, Rodari P, Castelli F, Zammarchi L, Bianchi L, Gobbi F, Cabezas-Fernandez T, Requena-Mendez A, Godbole G, Silva R, Romero M, Chiodini PL, Bisoffi Z. Multiple-dose versus single-dose ivermectin for Strongyloides stercoralis infection (Strong Treat 1 to 4): a multicentre, open-label, phase 3, randomised controlled superiority trial. Lancet Infect Dis. 2019 Nov;19(11):1181-1190. doi: 10.1016/S1473-3099(19)30289-0. Epub 2019 Sep 23.
Other Identifiers
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2011-002784-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTD1-2012
Identifier Type: -
Identifier Source: org_study_id
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