- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01052584
Ethiopia Malaria Therapeutic Efficacy Study
Ethiopia In-vivo Efficacy Study 2009: Evaluating the Efficacy of Artemether-lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Infection and Either Artemether-lumefantrine or Chloroquine for P. Vivax Infection
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Following the rapid development of significant drug resistance of Plasmodium falciparum (Pf) to chloroquine and then sulfadoxine-pyrimethamine (the first line therapy in Ethiopia 1998-2004), artemether- lumefantrine (Coartem or AL) was adopted as first line therapy in Ethiopia in 2004. According to the current national malaria diagnosis and treatment guidelines, first-line treatment for uncomplicated falciparum infection is AL. First-line treatment for Plasmodium vivax (Pv) is with chloroquine (CQ) alone without primaquine therapy in malarious areas. For all clinical infection without laboratory confirmation, AL which is effective against both Pf and Pv is the first-line treatment. Thus, in Ethiopia, where treatment for malaria without laboratory confirmation occurs frequently, Pv is often treated with AL as the standard of care. Furthermore, World Health Organization (WHO) recommends AL for the treatment of Pv, where AL has been adopted as first-line treatment for Pf. Now with wide-spread use of AL and CQ, we propose to conduct an antimalarial efficacy study to monitor the effectiveness of these therapies in Ethiopia and to determine how efficacious these drugs remain. This information will inform future policy changes with respect to appropriate antimalarial strategies.
The simplest and most universally accepted measure of testing for antimalarial drug treatment efficacy, the standardized procedures outlined in the World Health Organization Assessment and monitoring of antimalarial drug efficacy for the treatment of uncomplicated falciparum malaria and the WHO Monitoring antimalarial drug resistance, will be followed.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Oromia
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Debrezeit, Oromia, Etiopía
- DebreZeit Malaria Center
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Zeway, Oromia, Etiopía
- Bulbula Health Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Slide-confirmed infection with P. falciparum, with parasitemia of 1,000-100,000 asexual forms/ μl or slide confirmed infection with P. vivax with > 250 asexual forms/ μl
- Lives within 20 km of the enrolling health facility
- Weight ≥ 5.0 kg
- Axillary temperature ≥ 37.5º C or history of fever during the previous 24 or 48 hours for P. falciparum and P. vivax infection, respectively
- Patient or caregiver agrees to all blood draws and return visits.
Exclusion Criteria:
- General danger signs or symptoms of severe malaria
- Signs or symptoms of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean (NCHS/WHO normalized reference values;
- Slide confirmed infection with any other Plasmodium spp. besides falciparum/vivax or mixed plasmodium infection
- Severe anemia, defined as Hg < 5 g/dl
- Known hypersensitivity to any of the drugs being evaluated
- Presence of febrile conditions caused by diseases other than malaria
- Serious or chronic medical condition (cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)
- Pregnant or breastfeeding women.
- Children weighing less than 5 kilograms.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Chloroquine-P. vivax
P. vivax randomized to receive chloroquine 3-day regimen
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Total of 25mg base per kg over 3 days (10 mg base/kg on Days 1 and 2, and 5 mg base/kg on Day 3)
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Experimental: Artemether-Lumefantrine: P. vivax
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administered twice daily for three days as tablets containing 20 mg of artemether plus 120 mg of lumefantrine in a fixed dose combination at a dosage
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Experimental: Artemether-lumefantrine: P. falciparum
administered twice daily for three days as tablets containing 20 mg of artemether plus 120 mg of lumefantrine in a fixed dose combination at a dosage
|
administered twice daily for three days as tablets containing 20 mg of artemether plus 120 mg of lumefantrine in a fixed dose combination at a dosage
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Determine Early Treatment Failures, Late Clinical Failures, Late Parasitological Failures, or Adequate Clinical and Parasitological Response during 28 days of follow-up for P. falciparum. Measure the treatment failure of AL and CQ for P. vivax
Periodo de tiempo: 28 days
|
28 days
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Determine Early Treatment Failures, Late Clinical Failures, Late Parasitological Failures, or Adequate Clinical and Parasitological Response during 42 days of follow-up for P. falciparum. Measure the treatment failure of AL and CQ for P. vivax durin
Periodo de tiempo: 42 days
|
42 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jimee Hwang, MD, Centers for Disease Control and Prevention
Publicaciones y enlaces útiles
Publicaciones Generales
- Hwang J, Alemayehu BH, Reithinger R, Tekleyohannes SG, Takele Teshi, Birhanu SG, Demeke L, Hoos D, Melaku Z, Kassa M, Jima D, Malone JL, Nettey H, Green M, Poe A, Akinyi S, Udhayakumar V, Kachur SP, Filler S. In vivo efficacy of artemether-lumefantrine and chloroquine against Plasmodium vivax: a randomized open label trial in central Ethiopia. PLoS One. 2013 May 22;8(5):e63433. doi: 10.1371/journal.pone.0063433. Print 2013.
- Hwang J, Alemayehu BH, Hoos D, Melaku Z, Tekleyohannes SG, Teshi T, Birhanu SG, Demeke L, Gobena K, Kassa M, Jima D, Reithinger R, Nettey H, Green M, Malone JL, Kachur SP, Filler S. In vivo efficacy of artemether-lumefantrine against uncomplicated Plasmodium falciparum malaria in Central Ethiopia. Malar J. 2011 Jul 28;10:209. doi: 10.1186/1475-2875-10-209.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones
- Enfermedades transmitidas por vectores
- Enfermedades parasitarias
- Infecciones por protozoos
- Malaria
- Agentes antiinfecciosos
- Agentes antirreumáticos
- Agentes antiprotozoarios
- Agentes antiparasitarios
- Antipalúdicos
- Amebicidas
- Cloroquina
- Lumefantrina
- Arteméter
- Combinación de fármacos de arteméter y lumefantrina
Otros números de identificación del estudio
- CDC-NCZVED-5628
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