Comparing drug-regimens for clearing parasites in Phase IIb trial designs prior to PCR monitoring for Plasmodium falciparum infection

KEMRI Wellcome Trust Research Programme0 个研究点目标入组 90 人开始时间: 2013年8月22日最近更新: 2023年5月29日

适应症

试验速览

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•Consenting adults aged 18 ¿ 50 years in good health.
•Will remain resident in the study area for the study duration.
•Able and willing (in the Investigator¿s opinion) to comply with all study requirements
•Informed Consent

•Any significant medical disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
•Haemoglobin less than 11.3 g/dl for men and less than 10g/dl for in women, where judged to be clinically significant in the opinion of the investigator.
•Blood transfusion within the month preceding enrolment.
•Current participation in another clinical trial or recent participation within 12 weeks of this study.
•Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
•Pregnant or lactating women.
•Women unwilling to use contraception for the duration of drug treatment.
•Likelihood of travel away from the study area
•Withdrawal criteria
•By withdrawing consent
•On the decision of the investigator
•The investigator may withdraw the subject for the following reasons:
•Any adverse event which results in the inability to comply with study procedures
•Ineligibility either arising during the study or retrospectively
•Significant protocol deviation.
•Loss to follow up (applies to a subject who consistently does not return for protocol study visits, is not reachable by telephone or any other means of communication and/ is not able to be located).

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