Comparison Of The Efficacy Bioavailability, Safety Profile And Toxicity Of Artemisinin-Naphtoquinine-Primaquine (ArteGo) And Artemether ¿Lumefantrine In treatment of uncomplicated malaria in Lagos, Nigeria

KINGSGLAIVE CONSULTANTS,0 个研究点目标入组 120 人开始时间: 2017年10月4日最近更新: 2023年5月29日

适应症

试验速览

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•Clinical symptoms of malaria such as fever etc.
•age group: above 6 and below 60 years of age, male and female.
•Plasmodium falciparum asexual forms ¿ 500/¿L observed in peripheral blood smear;
•Have not been treated with any antimalarial
•Written informed consent, in accordance with local practice, provided by patient, for children it will provided by either parents or legal representative and in addition children will provide assent.
•Body weight between 20 kg and 90 kg (both inclusive)
•Presence of mono-infection with P. falciparum
•Ability to swallow oral medication
•Ability and willingness to adhere to all study procedures and access health facilities.
•Willing to undergo study related procedures including being hospitalized for minimum of 4 nights), and a follow up of up to 28 days.

•Age group below 6 or above 60 years
•Pregnant women
•Patients with signs and symptoms of severe/complicated malaria as described in the WHO guideline(Third Edition 2012) for management of severe malaria
•Mixed Plasmodial infection.
•Severe vomiting, defined as more than three times in the 24 hours prior to inclusion in the study or inability to tolerate oral treatment.
•Severe diarrhoea defined as 3 or more watery stools per day.
•Presence of other serious or chronic clinical condition requiring hospitalization.
•Known history or evidence of clinically significant disorders such as cardiovascular, respiratory (including active tuberculosis), history of jaundice, hepatic, renal, gastrointestinal, immunological, neurological (including auditory), endocrine, infectious, malignancy, psychiatric, history of convulsions or other abnormality (including head trauma).
•Family history of sudden death or of congenital prolongation of the QT interval or any other clinical condition known to prolong the QT interval.

发起方

KINGSGLAIVE CONSULTANTS,