Clinical trial NCT01570504: Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Strongyloidiasis
Keywords: Strongyloidiasis
Strongyloides stercoralis
Ivermectin
Lead sponsor: Centro per le Malattie Tropicali
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2012-04-04
Enrollment: 312
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: clearance of strongyloides infection
timeFrame: 12 months
Secondary outcomes:
measure: All-cause mortality during the 12 months of follow-up.
timeFrame: 12 months
measure: Patients with partial response to treatment at T 2
timeFrame: 12 months
measure: Patients with adverse reactions
timeFrame: From Day 1st to Day 5th of treatment and from Day 15th to Day 19th (or 72 hours from treatment completion)
measure: Patients with increase in blood ALT over cutoff value
timeFrame: Day 17
measure: Patients with decrease in WBC count below cutoff value
timeFrame: Day 17
measure: Average difference in blood ALT and WBC count at day 17, compared with baseline
timeFrame: Day 17
measure: Average difference in blood eosinophil count at T2, compared with baseline
timeFrame: 12 months
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: Centro per le Malattie Tropicali, Ospedale Sacro Cuore
state: Verona
city: Brescia
country: Italy
facility: Clinica di Malattie Infettive e Tropicali
city: Florence
country: Italy
facility: UFDID, Azienda Ospedaliero-universitaria Careggi
city: Florence
country: Italy
facility: Unità di Malattie Infettive, Anna Meyer Children's Universisty Hospital
city: El Ejido
country: Spain
facility: Unidad de Medicina, Hospital de Poniente-El Ejido
state: Almeria
city: Barcelona
country: Spain
facility: FCRB, Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Unitat Medicina Tropical i Salut Internacional Drassanes
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital, Cambridge University Hospital
city: London
country: United Kingdom
facility: UCLH
Study officials:
affiliation: Centre for Tropical Diseases, Negrar (Verona), Italy
name: Zeno Bisoffi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.