E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
La estrongiloidiasis está causada por un parásito que está globalmente distribuido por áreas tropicales y sub-tropicales. La mayoría de pacientes con estrongiloidiasis se encuentran asintomáticos o presentan síntomas leves con alteraciones gastrointestinales, síntomas respiratorios y lesiones cutáneas. En situaciones de defensas bajas (pacientes en tratamiento con corticoides, en trasplantados de órgano u otras situaciones) pueden presentar complicaciones graves con elevada mortalidad. |
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E.1.1.1 | Medical condition in easily understood language |
Strongyloidiasis is caused by a parasite that is distributed throughout tropical and subtropical areas. Most patients are asymptomatic or with mild symptoms. |
La estrongiloidiasis está causada por un parásito que está distribuido por áreas tropicales y sub-tropicales. La mayoría de pacientes se encuentran asintomáticos o con síntomas leves. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Parasitic Diseases [C03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042254 |
E.1.2 | Term | Strongyloidiasis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Evaluar la eficacia en términos de curación microbiológica y la seguridad de ivermectina en dosis única y fija de 18 mg para el tratamiento de la estrongiloidiasis no complicada en adultos inmunocompetentes en comparación con ivermectina en dosis única ajustada por peso. |
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E.2.2 | Secondary objectives of the trial |
-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. |
-Evaluar la seguridad, tolerabilidad y aceptabilidad de las dos dosificaciones de ivermectina en pacientes adultos con estrongiloidiasis no complicada. -Evaluar la utilidad del LAMP de S. stercoralis en muestras de heces y orina como herramienta en el diagnóstico y seguimiento tras el tratamiento de la estrongiloidiasis no complicada. -Conocer la farmacocinética poblacional de la ivermectina en dosis única y fija de 18 mg para el tratamiento de la estrongiloidiasis no complicada en pacientes adultos. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
-Edad igual o superior a 18 años. -Firma del consentimiento informado. -Diagnóstico de estrongiloidiasis ya sea por métodos parasitológicos directos (detección de larvas en el coproparasitológico o en el cultivo específico de Strongyloides) o por positividad de una técnica serológica (ELISA) con un índice de densidad óptica (DO) superior o igual a 2. -Residencia actual en una zona sin evidencia de transmisión activa de la estrongiloidiasis. |
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E.4 | Principal 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). |
-Embarazo o lactancia -Intolerancia o alergia a la ivermectina -Presencia de cualquier condición que suponga una inmunosupresión (tanto por fármacos como por enfermedad de base): tratamiento con corticosteroides a dosis superior o igual a 20 mg/día durante más de 14 días, tratamiento con citotóxicos o antimetabolitos, trasplante de médula ósea o de órgano sólido, fármacos biológicos, neoplasia sólida o hematológica activa, hipogammaglobulinemia, infección por el VIH con un recuento de CD4 inferior a 200 cel/mm3. -Insuficiencia renal (Filtrado glomerular igual o inferior a 30 ml/min) o enfermedad hepática avanzada (Child B o C). -Co-infección por Loa loa (por riesgo de presentar encefalopatía al administrar ivermectina). Estrongiloidiasis complicada: Síndrome de hiperinfestación por Strongyloides (enfermedad limitada a pulmones y tracto intestinal, pero con síntomas graves debido al elevado número de larvas) o estrongiloidiasis diseminada (se encuentran larvas en otros órganos fuera de pulmones y tracto intestinal). Viaje planeado a zona con evidencia de transmisión activa de la estrongiloidiasis durante los próximos 6 meses (para evitar posibles reinfecciones). Tratamiento previo con ivermectina (en el último año desde la fecha de inclusión). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients with microbiological cure at 6 months of treatment |
Proporción de pacientes con curación microbiológica a los 6 meses del tratamiento |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 6 months of treatment |
6 meses del tratamiento |
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E.5.2 | 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 |
-Evaluar la seguridad, tolerabilidad del tratamiento -Evaluar las pruebas diagnósticas para la detección de la estrongiloidiasis no complicada. -Conocer la farmacocinética poblacional de la ivermectina |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At 6 months of treatment |
6 meses del tratamiento |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Ivermectina peso dependiente |
Ivermectin dependent weight |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LPLV |
Última visita último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |