Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis (STRONGTREAT)
Primary Purpose
Strongyloidiasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ivermectin
Sponsored by
About this trial
This is an interventional treatment trial for Strongyloidiasis focused on measuring Strongyloidiasis, Strongyloides stercoralis, Ivermectin
Eligibility 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)
Sites / Locations
- Centro per le Malattie Tropicali, Ospedale Sacro Cuore
- Clinica di Malattie Infettive e Tropicali
- UFDID, Azienda Ospedaliero-universitaria Careggi
- Unità di Malattie Infettive, Anna Meyer Children's Universisty Hospital
- Unidad de Medicina, Hospital de Poniente-El Ejido
- FCRB, Hospital Clinic de Barcelona
- Unitat Medicina Tropical i Salut Internacional Drassanes
- Addenbrookes Hospital, Cambridge University Hospital
- UCLH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ivermectin multiple doses
1 dose ivermectin
Arm Description
A dose of 200 mcg/kg of ivermectin given on days 1,2, 15 and 16
A single 200 mcg/kg dose of ivermectin
Outcomes
Primary Outcome Measures
clearance of strongyloides infection
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.
Patients with partial response to treatment at T 2
Patients with adverse reactions
grade 1 to 5 as defined in detailed protocol
Patients with increase in blood ALT over cutoff value
Patients with decrease in WBC count below cutoff value
Average difference in blood ALT and WBC count at day 17, compared with baseline
Average difference in blood eosinophil count at T2, compared with baseline
Full Information
NCT ID
NCT01570504
First Posted
March 27, 2012
Last Updated
June 13, 2018
Sponsor
Centro per le Malattie Tropicali
Collaborators
European Commission
1. Study Identification
Unique Protocol Identification Number
NCT01570504
Brief Title
Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis
Acronym
STRONGTREAT
Official Title
Randomized, Open-label, Multi Centre Phase III Clinical Trial on Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
June 8, 2018 (Actual)
Study Completion Date
June 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro per le Malattie Tropicali
Collaborators
European Commission
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strongyloidiasis
Keywords
Strongyloidiasis, Strongyloides stercoralis, Ivermectin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
312 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ivermectin multiple doses
Arm Type
Experimental
Arm Description
A dose of 200 mcg/kg of ivermectin given on days 1,2, 15 and 16
Arm Title
1 dose ivermectin
Arm Type
Active Comparator
Arm Description
A single 200 mcg/kg dose of ivermectin
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Other Intervention Name(s)
Stromectol
Intervention Description
oral formulation
Primary Outcome Measure Information:
Title
clearance of strongyloides infection
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
All-cause mortality during the 12 months of follow-up.
Time Frame
12 months
Title
Patients with partial response to treatment at T 2
Time Frame
12 months
Title
Patients with adverse reactions
Description
grade 1 to 5 as defined in detailed protocol
Time Frame
From Day 1st to Day 5th of treatment and from Day 15th to Day 19th (or 72 hours from treatment completion)
Title
Patients with increase in blood ALT over cutoff value
Time Frame
Day 17
Title
Patients with decrease in WBC count below cutoff value
Time Frame
Day 17
Title
Average difference in blood ALT and WBC count at day 17, compared with baseline
Time Frame
Day 17
Title
Average difference in blood eosinophil count at T2, compared with baseline
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeno Bisoffi, MD, PhD
Organizational Affiliation
Centre for Tropical Diseases, Negrar (Verona), Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro per le Malattie Tropicali, Ospedale Sacro Cuore
City
Negrar
State/Province
Verona
ZIP/Postal Code
37024
Country
Italy
Facility Name
Clinica di Malattie Infettive e Tropicali
City
Brescia
Country
Italy
Facility Name
UFDID, Azienda Ospedaliero-universitaria Careggi
City
Florence
Country
Italy
Facility Name
Unità di Malattie Infettive, Anna Meyer Children's Universisty Hospital
City
Florence
Country
Italy
Facility Name
Unidad de Medicina, Hospital de Poniente-El Ejido
City
El Ejido
State/Province
Almeria
Country
Spain
Facility Name
FCRB, Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Facility Name
Unitat Medicina Tropical i Salut Internacional Drassanes
City
Barcelona
Country
Spain
Facility Name
Addenbrookes Hospital, Cambridge University Hospital
City
Cambridge
Country
United Kingdom
Facility Name
UCLH
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31558376
Citation
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.
Results Reference
derived
Learn more about this trial
Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis
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