Comparative Efficacy, Safety And Tolerability Of Three Treatment Regiments For Uncomplicated Falciparum Malaria: Artesunate (3 Days) + Amodiaquine (3 Days) Vs. Artésunate (3 Days) + Sulfadoxine-Pyriméthamine (1day) Vs. Artésunate (5 Days)

SANOFI-SYNTHELABO0 个研究点目标入组 750 人开始时间: 2018年1月26日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•The following criteria needed to be met for intry into the study:
•- Adults or children aged 6 months or older and weighing more than 5Kg
•- Residents of Bougoula-Hameau during the entire follow up period
•- Oral treatment possible
•- Axiliary temperature >= 37.5oC .
•- Infection with Plasmodium specie with parasite density between 2000 and 200000
•trophozoites/mm3.
•- Informed consent or informed assent obtained from the patient or parent/guardian

•EXCLUSION CRITERIA
•- Presence of symptoms of severe or cerebral malaria: coma, unconsciousness, recent or
•repeated seizures, acute pulmonary edema, unable to drink, repeated vomiting,
•macroscopic hemoglobinueria, jaundice, hemorrhagic shock (systolic blood pressure <
•70 mm Hg in adults, <50 in children), spontaneous bleeding, hypoglycemia (<40mg/dl),
•renal failure (creatinine > 3mg/dL).
•- Concomitant severe illness,
•- Severe anemia: hemoglobine <= 5g/dL
•- Allergy to one of the study drugs
•- Pregnancy (disclosed or clinically patent pregnancy).
•- Documented consumption of one of the study drugs during the preceding 7 days.

发起方