Study comparing different doses of the drug ivermectin for the treatment of strongyloidiasis
- Conditions
- strongyloidiasisTherapeutic area: Diseases [C] - Parasitic Diseases [C03]
- Registration Number
- EUCTR2011-002784-24-ES
- Lead Sponsor
- Sacro Cuore - Don Calabria Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Male and female patients older than 5 years weighting > 15 kg. Current residence in non endemic areas. Diagnosis of strongyloidiasis by positive stool examination and/or stool culture AND positive serology at any titer OR positive serology at high titer. Informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Exclusion Criteria
Pregnant or lactating women. CNS diseases. Disseminated strongyloidiasis. Immunosuppressed patients. Lack of informed consent. Previous treatment (last year) with ivermectin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare different dose schedules of ivermectin for the treatment of strongyloidiasis;Secondary Objective: Safety and tolerability of ivermectin;Primary end point(s): Clearance of strongyloidiasis at T2 (time 2: 12 months after recruitment);Timepoint(s) of evaluation of this end point: 12 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): All-cause mortality during the 12 months of follow up. Patients with partial response to the treatment. Patients with adverse reactions. Patients with symptoms cleared/not cleared at T2. Patients with incread ALT at day 17. Patients with decreased WBC count at day 17. Average difference in ALT and WBC count at day 17, compared to baseline. Average difference in eosinophil count at T2, compared with baseline;Timepoint(s) of evaluation of this end point: 12 months