NCT01570504

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_3

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2018

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

5.3 years

First QC Date

March 27, 2012

Last Update Submit

June 13, 2018

Conditions

Strongyloidiasis

Keywords

StrongyloidiasisStrongyloides stercoralisIvermectin

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (7)

  • All-cause mortality during the 12 months of follow-up.

    12 months

  • Patients with partial response to treatment at T 2

    12 months

  • 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)

  • Patients with increase in blood ALT over cutoff value

    Day 17

  • Patients with decrease in WBC count below cutoff value

    Day 17

  • +2 more secondary outcomes

Study Arms (2)

ivermectin multiple doses

EXPERIMENTAL

A dose of 200 mcg/kg of ivermectin given on days 1,2, 15 and 16

Drug: Ivermectin

1 dose ivermectin

ACTIVE COMPARATOR

A single 200 mcg/kg dose of ivermectin

Drug: Ivermectin

Interventions

IvermectinDRUG

oral formulation

Also known as: Stromectol
1 dose ivermectinivermectin multiple doses

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Centro per le Malattie Tropicali, Ospedale Sacro Cuore

Negrar, Verona, 37024, Italy

Location

Clinica di Malattie Infettive e Tropicali

Brescia, Italy

Location

UFDID, Azienda Ospedaliero-universitaria Careggi

Florence, Italy

Location

Unità di Malattie Infettive, Anna Meyer Children's Universisty Hospital

Florence, Italy

Location

Unidad de Medicina, Hospital de Poniente-El Ejido

El Ejido, Almeria, Spain

Location

FCRB, Hospital Clinic de Barcelona

Barcelona, Spain

Location

Unitat Medicina Tropical i Salut Internacional Drassanes

Barcelona, Spain

Location

Addenbrookes Hospital, Cambridge University Hospital

Cambridge, United Kingdom

Location

UCLH

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 31558376DERIVED

MeSH Terms

Conditions

Strongyloidiasis

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Rhabditida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Zeno Bisoffi, MD, PhD

    Centre for Tropical Diseases, Negrar (Verona), Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2012

First Posted

April 4, 2012

Study Start

March 1, 2013

Primary Completion

June 8, 2018

Study Completion

June 8, 2018

Last Updated

June 14, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)ES(3)IT(4)