The anti-infectivity efficacy and pharmacokinetics of WHO-recommended single low dose primaquine in children with acute Plasmodium falciparum

niversity of Oxford0 个研究点目标入组 56 人开始时间: 2021年7月26日最近更新: 2024年9月9日

适应症

试验速览

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39227956/ (added 04/09/2024)

•1. Participant parent/legal guardian is willing and able to give informed consent for participation in the study
•2. Aged =6 months and <5 years
•3. Weight =5 kg
•4. Presentation with fever (axillary =37.5°C, tympanic =38°C) or fever history =24 h and clinically uncomplicated disease
•5. P. falciparum parasitaemia 1,000 – 250,000/µl (mono-/mixed Plasmodium species) detected by light microscopy
•6. Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule

•1. General danger signs in children under 5 years or signs of severe falciparum malaria according to the definitions of WHO (2000) e.g. prostration, respiratory distress, reduced consciousness
•2. Persistent vomiting as given in the history of the current illness
•3. P. falciparum (Pf) parasitaemia >250,000/µl (>5% parasitaemia)
•4. Haemoglobin (Hb) <5 g/dl
•5. Patients on treatment for a significant illness e.g. HIV/AIDS, TB, leprosy or currently taking a drug known to cause haemolysis in G6PDd
•6. Known to be allergic to PQ or ASPYR
•7. On regular medication, which might interfere with antimalarial pharmacokinetics
•8. Antimalarials taken within the last 2 weeks
•9. Having taken a herbal medicine within the last 4 weeks
•10. Previous participation in a malaria vaccine trial
•11. Previous enrolment in the current trial or current enrolment in another trial
•12. Severe malnutrition – defined as a mid-upper arm circumference (MUAC) <115 mm
•13. Febrile condition due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal or hepatic diseases, HIV/AIDS)

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