PER-068-04已完成未知
EFFECTIVENESS OF THREE DIFFERENT PRIMAQUINE SCHEMES, FOR THE PREVENTION OF MALARIA BY PLASMODIUM VIVAX IN THE AMAZON REGION OF PER
INSTITUTO DE INVESTIGACION DE ENFERMEDADES TROPICALES DE LA MARINA DE LOS E.E.U.U (NMRCD), Instituto Nacional de Salud - INS (Peru),0 个研究点目标入组 0 人开始时间: 2004年10月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Age> 1 year.
- •Documented fever (axillary temperature> 37.5 ° C) or a history of fever during the past 72 hours in the absence of another obvious cause of fever (such as pneumonia, otitis media).
- •Monoinfection with P. vivax between 250 and 100,000 asexual parasites / pl determined by microscopic examination of thick drop, or thick drop and peripheral smears.
- •Informed consent of the patient or parent / guardian (in the case of children), assent of the child (including ages between 8 and 17 years);
- •Patient´s intention to return to the health center for regular check-ups during a 28-day follow-up period and stay in the locality for 6 months for home visits.
排除标准
- •Signs of danger: not being able to drink or breastfeed; vomiting (more than twice in the previous 24 hours); recent history of seizures (one or more in the previous 24 hours); affected conscience; unable to sit or stand
- •Signs of severe malaria (WHO criteria)
- •to. Brain malaria (irreversible coma)
- •b. Severe anemia (hematocrit <15% or clinical signs)
- •c. Renal failure (serum creatinine> 3 mg / dL or clinical signs)
- •d. Pulmonary edema
- •and. Hypoglycemia (blood glucose <40mg / dL or clinical signs)
- •F. Shock (systolic pressure <70 mm Hg in adults, 50 mm Hg in children)
- •g. Spontaneous bleeding / CID
- •h. Repeated generalized seizures
- •i. Acidemia / acidosis (clinical signs)
- •j. Macroscopic hemoglobinuria
- •k. Jaundice
- •Other underlying chronic or severe diseases (eg: heart, kidney, liver disease, HIV / AIDS, tuberculosis, malnutrition); which will be diagnosed through the evaluation of the clinical history or the physical examination.
- •History of hypersensitivity reactions to any of the drugs under evaluation or that are being used as an alternative treatment: quinine, tetracycline or clindamycin)
- •Pregnancy (both pregnancy antecedent and positive urine pregnancy test).
- •Breastfeeding
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