Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis

Strongyloidiasis Clinical Trial

— STRONGTREAT  

Official title:

Randomized, Open-label, Multi Centre Phase III Clinical Trial on Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570504
• Other study ID #: CTD1-2012
• Secondary ID: 2011-002784-24
• Status: Completed
• Phase: Phase 3
• Start date: March 2013
• Est. completion date: June 8, 2018

Study information

• Verified date: June 2018
• Source: Centro per le Malattie Tropicali
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: June 8, 2018
• Est. primary completion date: June 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Strongyloidiasis

Intervention

Drug:
• Ivermectin
oral formulation

Locations

Country	Name	City	State
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	Centro per le Malattie Tropicali, Ospedale Sacro Cuore	Negrar	Verona
Spain	FCRB, Hospital Clinic de Barcelona	Barcelona
Spain	Unitat Medicina Tropical i Salut Internacional Drassanes	Barcelona
Spain	Unidad de Medicina, Hospital de Poniente-El Ejido	El Ejido	Almeria
United Kingdom	Addenbrookes Hospital, Cambridge University Hospital	Cambridge
United Kingdom	UCLH	London

Sponsors (2)

Lead Sponsor	Collaborator
Centro per le Malattie Tropicali	European Commission

Countries where clinical trial is conducted

Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause mortality during the 12 months of follow-up.		12 months
Secondary	Patients with partial response to treatment at T 2		12 months
Secondary	Patients with adverse reactions	grade 1 to 5 as defined in detailed protocol	From Day 1st to Day 5th of treatment and from Day 15th to Day 19th (or 72 hours from treatment completion)
Secondary	Patients with increase in blood ALT over cutoff value		Day 17
Secondary	Patients with decrease in WBC count below cutoff value		Day 17
Secondary	Average difference in blood ALT and WBC count at day 17, compared with baseline		Day 17
Secondary	Average difference in blood eosinophil count at T2, compared with baseline		12 months