Efficacy and safety of Ivermectin for the treatment of Plasmodium falciparum infections in asymptomatic Gabonese adults

Centre de Recherches Medicales de Lambarene0 个研究点目标入组 49 人开始时间: 2019年7月12日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Male or female, aged = 18 years and body weight = 45 kg
•-P. falciparum parasitaemia of 200 to 5000 parasites/µL
•-Asymptomatic malaria defined as: presence of P. falciparum mono-infection with absence of fever (axillary temperature <38.5 °C and absence of history of fever in the recent 24 hours and the week before inclusion) and other symptoms re-lated to malaria
•-Willingness to take part in the study and to sign the informed consent form

•-Active tuberculosis, or history of taking anti-tuberculosis medications within 12 months prior to screening
•-any Loa loa microfilaria infection detected by microscopy
•-AST/ALT > 2x the upper limit of normal range (ULN)
•-Taking an experimental drug in the last 4 weeks
•-Antimalarial treatment in the last 4 weeks
•-Use of systemic antibiotics with known antimalarial activity within 30 days of study enrolment (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones, or azithromycin)
•-Use of ivermectin within 30 days of study enrolment
•-Participants taking herbal medication within one week of screening
•-Known or suspected electrolyte imbalance, e.g. hypokalae-mia, hypocalcaemia or hypomagnesemia with clinical signif-icance
•-Moderate to severe anaemia (Haemoglobin level <8 g/dL)
•-Any known or suspected immunosuppressive or immunode-ficient condition, including human immunodeficiency virus (HIV) infection
•-Severe malnutrition (Body Mass Index (BMI) < 16.0)
•-Pregnant or nursing (lactating) women
•-Known chronic underlying disease such as sickle cell disease or severe cardiac impairment
•-Participants with serum creatinine = 2 X ULN in the absence of dehydration. In case of dehydration, Participants with se-rum creatinine = 2 X ULN after oral or parenteral rehydration
•-Participants with any psychiatric or neurological condition including substance abuse
•-Allergy to ivermectin

发起方

Centre de Recherches Medicales de Lambarene