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: 20.0 Level: PT Classification code 1004
Conditions
Interventions
Product Name: Ivermectin
Pharmaceutical Form: Tablet
Sponsors
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 221 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy in terms of microbiological cure and safety of 18 mg single fixed dose ivermectin for the treatment of uncomplicated strongyloidiasis in immunocompetent adults compared to weight-adjusted single dose ivermectin.;Secondary Objective: -To assess the safety, tolerability and acceptability of the two dosages of ivermectin in adult patients with uncomplicated strongyloidiasis. -To evaluate the usefulness of the LAMP of S. stercoralis in stool and urine samples as a tool in the diagnosis and follow-up after treatment of uncomplicated strongyloidiasis. -To know the population pharmacokinetics of ivermectin in a single and fixed dose of 18 mg for the treatment of uncomplicated strongyloidiasis in adult patients.;Primary end point(s): Proportion of patients with microbiological cure at 6 months of treatment;Timepoint(s) of evaluation of this end point: At 6 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Evaluate the safety, tolerability of the treatment -Evaluate the diagnostic tests for the detection of uncomplicated strongyloidiasis. -To know the population pharmacokinetics of ivermectin;Timepoint(s) of evaluation of this end point: At 6 months of treatment | — |
Countries
Spain
Contacts
Public ContactFernando Salvador
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Outcome results
None listed