The Effect of Paracetamol in the Treatment of Non-severe Malaria in Children in Guinea-Bissau
acetaminophen (paracetamol)
+ Placebo
Enfermedades transmitidas por mosquitos+3
+ Enfermedades transmitidas por vectores
+ Infecciones
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 2004
Fecha en la que se inscribió al primer participante.A Cochrane Review was unable to show a superior antipyretic effect of paracetamol compared with placebo in febrile children. Recent research suggests that the time to parasite clearance in non-severe malaria is longer in children being given paracetamol. As the costs associated with the use of paracetamol is not trivial and the risk of adverse effects is not negligible, we want to evaluate the effects of paracetamol on: * the well-being of the child; * the parasite clearance time; and * the recrudescence rate. Children presenting at Bandim Health Centre with symptoms of malaria and a malaria film showing mono-infection with P.falciparum will, following consent to participate, randomly be allocated to treatment with chloroquine and paracetamol or with chloroquine and placebo. Blood samples will be obtained daily for the first 4 days. The children will be visited and a malaria film taken on day 7 and then weekly until day 35. On inclusion and whenever parasitaemia is detected a capillary blood sample will be taken for PCR analyses to be able to distinguish re-infection from recrudescence. During follow-up children are recommended to present at the health centre in case of persistent fever or any other symptoms. Examination and treatment will be free of charge. Whenever a child has re-infection sulfadoxine/pyrimethamine will be used for re-treatment following the recommendation of the National malaria Programme. After the inclusion of 80 children a preliminary analysis will be performed. If 50% or more of the children in any of the study arms have reappearing parasitaemia the study will be terminated. If the parasite clearance time and especially the recrudescence rate is higher for children being given paracetamol the current recommendation from the National Malaria Programme should be reconsidered. If children treated with paracetamol feel better during the acute illness making it more likely for them to have en adequate intake of food and liquid this benefit should be considered in the evaluation of the current recommendations.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Hasta 15 Años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
PlaceboObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación