IVERMECTIN for Strongyloidiasis

Inclusion criteria

• {"criterion_text":"- Age equal to or greater than 18 years.\n- Signature of the informed consent.\n- Diagnosis of strongyloidiasis either by direct parasitological methods (detection of larvae in coproparasitology or in the specific Strongyloides culture) or by positivity of a serological technique (ELISA) with an optical density index (OD) greater than or equal to 2.\n- Current residence in an area with no evidence of active transmission of strongyloidiasis."}

Exclusion criteria

• {"criterion_text":"- Pregnancy or lactation\n- Intolerance or allergy to ivermectin.\n- Presence of any condition that implies immunosuppression (both due to drugs and underlying disease): treatment with corticosteroids at a dose greater than or equal to 20 mg/day for more than 14 days, treatment with cytotoxic or antimetabolites, bone marrow transplantation or Solid organ failure, biologic drugs, active solid or hematologic neoplasm, hypogammaglobulinemia, HIV infection with a CD4 count less than 200 cells/mm3.\n- Kidney failure (glomerular filtration rate equal to or less than 30 ml/min) or advanced liver disease (Medical history and liver function profile).\n- Loa loa co-infection (due to risk of encephalopathy when administering ivermectin).\n- Complicated strongyloidiasis: Hyperinfestation syndrome due to Strongyloides (disease limited to the lungs and intestinal tract, but with severe symptoms due to the high number of larvae) or disseminated strongyloidiasis (larvae found in organs outside the lungs and intestinal tract).\n- Planned travel to an area with evidence of active strongyloidiasis transmission in the next 6 months (to prevent possible reinfections).\n- Previous treatment with ivermectin (in the last year from the inclusion date)."}

Primary endpoints

• {"endpoint_text":"- Proportion of patients with microbiological cure at 6 months of treatment.","definition_or_measurement_approach":"Microbiological cure assessed at 6 months after treatment (endpoint statement provided; specific microbiological methods for primary endpoint not detailed here)."}

Spain

Earliest CTIS Part Ii Submission Date

28-06-2024

Latest Decision Or Authorization Date

05-12-2025

Processing Time Days

525

Number Of Sites

7

Number Of Participants

276

Primary sponsor

Full Name

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain