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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002784-24 | EudraCT Number |
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| Name | Class |
|---|---|
| European Commission | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ivermectin multiple doses | Experimental | A dose of 200 mcg/kg of ivermectin given on days 1,2, 15 and 16 |
|
| 1 dose ivermectin | Active Comparator | A single 200 mcg/kg dose of ivermectin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin | Drug | oral formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality during the 12 months of follow-up. | 12 months | |
| Patients with partial response to treatment at T 2 | 12 months | |
| Patients with adverse reactions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeno Bisoffi, MD, PhD | Centre for Tropical Diseases, Negrar (Verona), Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro per le Malattie Tropicali, Ospedale Sacro Cuore | Negrar | Verona | 37024 | Italy | ||
| Clinica di Malattie Infettive e Tropicali |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31558376 | Derived | 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. |
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| ID | Term |
|---|---|
| D013322 | Strongyloidiasis |
| ID | Term |
|---|---|
| D017196 | Rhabditida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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grade 1 to 5 as defined in detailed protocol |
| 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 | Day 17 |
| Patients with decrease in WBC count below 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 |
| 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 |
| D010272 |
| Parasitic Diseases |
| D007239 | Infections |