Assessing the safety and tolerability of artemether-lumefantrine+atovaquone-proguanil tri-therapy for malaria treatment in adults and adolescents in Gabon: a two-arm randomized, placebo-controlled, participant, observer and analyser blinded mono-centre, Phase IIb clinical pilot trial

Kwame Nkrumah University of Science and Technology0 个研究点目标入组 60 人开始时间: 2020年10月6日最近更新: 2021年1月5日

适应症

试验速览

暂无简介。

•1. Adults and adolescents aged 15 years and older
•2. Body weight =40 kg
•3. Fever (=37.5°C axillary body temperature) or history of fever in the preceding 24 hours
•4. Uncomplicated P. falciparum monoinfection with equal or more than 1,000 and less than 200,000 asexual P. falciparum parasites per µl of blood
•5. Signed written informed consent
•6. Ability to comply with study procedures and follow-up schedules
•7. Ability to take oral medication

•1. Reported intake of any antimalarial drug including halofantrine within the previous month
•2. Intake of drugs with some antimalarial activity or that interference with tolerability assessment (including cotrimoxazole/bactrim, tetracyclines, quinolones and fluoroquinolones, and azithromycin) within the previous month
•3. Presence of severe malaria following WHO definition (see Annex 2: WHO definitions for severe malaria)
•4. Known history or evidence of clinically significant medical disorders
•5. Severe malnutrition assessed by BMI
•6. Previous participation in a malaria vaccine study
•7. Screening haemoglobin level <7 g/dL
•8. Known hypersensitivity or contraindications to any AL+AP components
•9. Administration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, millepertuis/St John’s wort (hypericum perforatum)
•10. Known QT prolongation (e.g. hypokalaemia, hypomagnesemia)
•11. Pregnant or lactating women
•12. Participation in other interventional studies

发起方