An Open-label, Randomised, Controlled, Non-inferiority Trial to Compare the Efficacy, Safety and Tolerability of a Fixed Dose Triple Artemisinin-based Combination Therapy (TACT) Artemether-lumefantrine-amodiaquine Versus First-line Artemisinin-based Combination Therapies (ACTs) for the Treatment of Uncomplicated Plasmodium Falciparum Malaria

The goal of this open-label randomised, controlled, non-inferiority trial is to assess and compare the efficacy, tolerability and safety of a fixed dose TACT artemether-lumefantrine-amodiaquine (ALAQ) to the ACTs artemether-lumefantrine (AL), artesunate-amodiaquine (ASAQ) (with single low-dose primaquine in some sites) for the treatment of uncomplicated Plasmodium falciparum malaria in patient. The main question it aims to answer is whether ALAQ, a fixed dose TACT, is as efficacious, safe and tolerable in comparison with AL and ASAQ.
Participants will be enrolled, admitted and randomised to receive the study drug (ALAQ, AL or ASAQ). Patients will receive directly observed treatments and will be followed up at least once daily for the first 3 days after enrolment followed by weekly visits from D7 up to D42. Patients will be asked to report to the clinics between scheduled visits in case of any illness or other symptoms or complaints.

开始日期2024-01-01

申办/合作机构

University of Oxford

100 项与蒿甲醚/本芴醇/盐酸阿莫地喹相关的临床结果

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100 项与蒿甲醚/本芴醇/盐酸阿莫地喹相关的转化医学

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100 项与蒿甲醚/本芴醇/盐酸阿莫地喹相关的专利（医药）

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项与蒿甲醚/本芴醇/盐酸阿莫地喹相关的文献（医药）

2024-06-02·Food Additives & Contaminants: Part A

The occurrence of aflatoxins and labelling compliance of locally produced za’atar mix products

Article

作者: Mudalal, Samer

Za'atar mix products are mainly composed of the dried and ground leaves and/or blossoms of wild and cultivated plant species (Origanum, Thymbra, Thymus, and Satureja) with the addition of condiments. The aim of this study was to evaluate the occurrence of aflatoxins, chemical composition (carbohydrates, fibre, fat, protein, moisture, ash, and acid contents), mineral content (Na, Ca, and K), and colour traits (L*a*b*) in relation to food label and food standards compliance. Measured and labelled fat content did not agree for approximately 91% of the samples. There was also no agreement between the measured and labelled fibre contents. The total content of aflatoxins in the tested samples ranged from 2 to 63.7 ng g^-1. Eleven (69%) of the 16 analysed products had total aflatoxins higher than the maximum permitted limit of the European Commission. The KAS and LAZ products had significantly lighter colour (the highest L* values), while the ALAQ product had the darkest colour (lowest L* value). The range of sodium content in the tested products was 105.1-1425.3 mg/100 g. In conclusion, za'atar mix products that are available in local markets do not have accurate nutritional labelling information, and the occurrence of aflatoxins was very high. Further studies are needed to evaluate the reasons for these quality defects.

100 项与蒿甲醚/本芴醇/盐酸阿莫地喹相关的药物交易

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