Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis

Phase 3

Completed

• Conditions: Strongyloidiasis
• Interventions: Drug: Ivermectin

• Registration Number: NCT01570504
• Lead Sponsor: Centro per le Malattie Tropicali

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-04-02
• Study First Posted: 2012-04-04
• Study Start: 2013-03
• Status Verified: 2018-06
• Primary Completion: 2018-06-08
• Study Completion: 2018-06-08
• Last Update Submitted: 2018-06-13
• Last Update Posted: 2018-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 dose ivermectin	Ivermectin	A single 200 mcg/kg dose of ivermectin
ivermectin multiple doses	Ivermectin	A dose of 200 mcg/kg of ivermectin given on days 1,2, 15 and 16

Primary Outcome Measures

Name	Time	Method
clearance of strongyloides infection	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

Name	Time	Method
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)	grade 1 to 5 as defined in detailed protocol
Patients with increase in blood ALT over cutoff value	Day 17
Average difference in blood ALT and WBC count at day 17, compared with baseline	Day 17
Average difference in blood eosinophil count at T2, compared with baseline	12 months
Patients with decrease in WBC count below cutoff value	Day 17
All-cause mortality during the 12 months of follow-up.	12 months

Trial Locations

Locations (9)

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