Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis

Centro per le Malattie Tropicali312 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

312

Conditions

Strongyloidiasis

Interventions

IvermectinDRUG

oral formulation

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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)

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

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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

Time frame: 12 months

Patients with partial response to treatment at T 2

Time frame: 12 months

Patients with adverse reactions

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)

Patients with increase in blood ALT over cutoff value

Time frame: Day 17

Patients with decrease in WBC count below cutoff value

Time frame: Day 17

Average difference in blood ALT and WBC count at day 17, compared with baseline

Time frame: Day 17

Average difference in blood eosinophil count at T2, compared with baseline

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.