- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00372632
IPT of Malaria With SP in Different Zones of Drug Resistance in Rwanda
Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in Different Zones of Drug Resistance in Rwanda
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The present study will address the question whether the use of IPT using SP in pregnancy is efficacious in Rwanda, where it is going to be used for the first time, in areas with high levels of SP resistance. While the implementation of the new policy will take place in areas at low SP resistance level, where we expect pregnant women and newborns to benefit from it, it is of paramount importance to clarify which is the real impact of IPT/SPin areas of high SP drug resistance and at what level of SP resistance this strategy is still efficacious. As bed nets are a part of the actual control strategy of malaria in pregnancy all women will receive a bed net at enrolment.
This will be a randomized blinded placebo controlled trial: women in the 16-28th week of gestation will be offered enrolment into the study and randomized to receive IPT/SP regimen or placebo once during the second and once in the third trimesters.
The study will be conducted in Mashesha (estimated SP drug resistance 20%, 12% in 2000), Kicukiro (40% SP resistance) and Rukara (60% SP resistance). In each of these sites there are about 1000 deliveries per year. According to DHMT data, over 75% of pregnant women attend antenatal clinics, usually booking between 15 and 25 weeks of gestation. Based on this study we expect to find placental malaria prevalence over 50% in all sites.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Kigali, Ruanda
- Programme Nationale de Controle de Paludisms
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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:
- Pregnant women between 16-28 weeks of gestation;
- Residence within the catchment's area of the health facility;
- Willing to deliver at the health facility;
- Willing to ; adhere to all requirements of the study;
- Willing to provide written informed consent;
- Aged 21 years and above
Exclusion Criteria:
- Severe anemia (Hb < 6 g/dL)
- History of allergic reactions to sulfa drugs;
- Taking other sulfa drugs as CTX;
- History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section);
- History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis, prior to randomization;
- Any significant illness that requires hospitalization;
- Intent to move out of the study catchment's area before delivery or deliver at relative's home out of the catchment's area;
- Prior enrollment in the study or concurrent enrollment in another study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: placebo
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The control group receives placebo similar in taste and appearance to to the experimental arm
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Experimental: sulfadoxine-pyrimethamine
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The intervention group receives 1500mg of sulfadoxine and 75mg of pyrimethamine at enrollment and in the third trimester.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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malaria infection will be defined as the presence of asexual stage parasites on thick smears made with maternal side placental blood and Maternal peripheral blood
Periodo de tiempo: maternal placental blood at delivery; maternal peripheral blood at monthly visits between 16 weeks of gestation and delivery
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maternal placental blood at delivery; maternal peripheral blood at monthly visits between 16 weeks of gestation and delivery
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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LBW = birth weight <2,500 grams
Periodo de tiempo: at delivery
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at delivery
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Premature delivery = delivery prior to 37 weeks gestation
Periodo de tiempo: at delivery
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at delivery
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Spontaneous miscarriage = any spontaneous abortion before the end of gestation
Periodo de tiempo: at delivery
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at delivery
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Stillbirth
Periodo de tiempo: at delivery
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at delivery
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Cord blood parasitaemia = presence of asexual stage parasites in thick smears
Periodo de tiempo: at delivery
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at delivery
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Neonatal death = infant death within the first 28 days of life
Periodo de tiempo: 7days and 6 weeks after delivery
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7days and 6 weeks after delivery
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Maternal anemia = Hb <11.0 g/dL
Periodo de tiempo: at monthly visits between 16 weeks of gestation and delivery
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at monthly visits between 16 weeks of gestation and delivery
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Maternal severe anemia = Hb <6 g/dL
Periodo de tiempo: at monthly visits between 16 weeks of gestation and delivery
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at monthly visits between 16 weeks of gestation and delivery
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Symptomatic maternal malaria infection = axillary temperature 37.5°C and asexual parasitaemia
Periodo de tiempo: at monthly visits between 16 weeks of gestation and delivery
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at monthly visits between 16 weeks of gestation and delivery
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Severe maternal adverse reactions to SP = severe cutaneous reactions (e.g., erythema multiform, Stevens-Johnson syndrome, or toxic epidermal necrolysis)
Periodo de tiempo: at monthly visits between 16 weeks of gestation and delivery plus at day 7 and week 6 after delivery
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at monthly visits between 16 weeks of gestation and delivery plus at day 7 and week 6 after delivery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Umberto D'Alessandro, MD,MSc, PHD, Institute of Tropical Medicine Antwerp
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
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Inhibidores de enzimas
- Agentes antiprotozoarios
- Agentes antiparasitarios
- Antipalúdicos
- Antagonistas del ácido fólico
- Agentes Antiinfecciosos Urinarios
- Agentes renales
- Pirimetamina
- Sulfadoxina
- Fanasil, combinación de drogas de pirimetamina
Otros números de identificación del estudio
- 05 34 5 520
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