In vivo study to monitor the sensitivity of Plasmodium falciparum and other species to Pyronaridineartesunate and Artemether-lumefantrine in Niger.

European and Developping Countries Clinical Trials partnership EDCTP0 个研究点目标入组 240 人开始时间: 2020年7月3日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Patients aged 6 months and over with P. falciparum and / or other species;
•Have an axillary temperature greater than or equal to 37.5 ° C or failing this, the onset of a fever in the last 24 hours must be found during questioning.
•Parasitaemia must be between 1000 and 200,000 / µL;
•Informed consent / assent must be obtained from the patient or, if it is a child, from the person responsible for it after receiving specific information from the protocol

•Non-inclusion criteria
•The presence of one or more general danger signs or any sign of severe or complicated malaria defined by WHO
•Refusal to sign or affix his fingerprint on the informed consent;
•Any contraindication to any of the molecules in a combination or the presence of a history of allergy;
•Pregnancy clinically evident or found on interrogation;
•Patients who have received antimalarial treatment for less than 14 days.
•Study discontinuation criteria for participants
•Withdrawal of informed consent;
•Protocol violation:
•Administration of an antimalarial treatment other than Pyr-AS or AL;
•Intercurrent pathology which may interfere with the classification of the therapeutic response;
•Detection of an infection by another plasmodial species during monitoring;
•Incorrect inclusion (non-compliance with inclusion criteria / non-inclusion)
•Patient lost to follow-up
•Appearance of a serious adverse event
•Death or event endangering the participant's survival
•Event resulting in a significant or lasting incapacity or handicap ...
•Inability to take treatment
•Repeated vomiting (= two)
•Absence = 1 follow-up visit during periods taken with AL or Pyr-AS
•Serious adverse event.

发起方

European and Developping Countries Clinical Trials partnership EDCTP