Clinical trial with ivermectin to treat strongyloidiasis with the aim of demonstrating that both the independent and weight-dependent dose of the patient have the same response.

Phase 1

• Conditions: Strongyloidiasis is caused by a parasite that is globally distributed in tropical and sub-tropical areas. Most patients with strongyloidiasis are asymptomatic or have mild symptoms with gastrointestinal disturbances, respiratory symptoms, and skin lesions. In situations of low defenses (patients under treatment with corticosteroids, organ transplant recipients or other situations) they can present serious complications with high mortality.; MedDRA version: 20.0Level: PTClassification code: 10042254Term: Strongyloidiasis Class: 100000004862; Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: CTIS2024-515968-32-00
• Lead Sponsor: Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-15
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

Age equal to or greater than 18 years., Signature of the informed consent., 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., Current residence in an area with no evidence of active transmission of strongyloidiasis.

Exclusion Criteria

Pregnancy or lactation, Intolerance or allergy to ivermectin., 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., Kidney failure (glomerular filtration rate equal to or less than 30 ml/min) or advanced liver disease (Child B or C)., Loa loa co-infection (due to risk of encephalopathy when administering ivermectin).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified