Strongyloidiasis
Conditions
Keywords
Strongyloidiasis, Strongyloides stercoralis, Ivermectin
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.
Interventions
DRUGIvermectin
oral formulation
Sponsors
European Commission
Centro per le Malattie Tropicali
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| All-cause mortality during the 12 months of follow-up. | 12 months | — |
| 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 | — |
Countries
Italy, Spain, United Kingdom
Outcome results
None listed