Assessing the tolerability and safety of single low dose primaquine in African children with acute uncomplicated falciparum malaria and glucose 6 phosphate dehydrogenase deficiency in Africa

The University of Oxford0 个研究点目标入组 1,137 人开始时间: 2017年5月9日最近更新: 2023年10月30日

试验速览

2018 Other publications in https://pubmed.ncbi.nlm.nih.gov/29347975/ Age-based dosing regimen development (added 21/10/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36462528/ (added 05/12/2022) 2023 Results article in https://doi.org/10.1186/s12916-023-03105-0 (added 20/10/2023)

•1. Aged six months to 11 years old
•2. Clinically uncomplicated disease
•3. Fever (= 37.5°C aural) or history of fever within the previous 72 hours
•4. Positive malaria RDT (Uganda only)
•5. Positive malaria slide for P. falciparum (mono or mixed infection) of any parasitaemia (Kinshasa only)
•6. Informed consent provided by patient or relative/legal guardian

•1. Malaria danger signs, sign(s) of severe malaria, or decompensated anaemia, including: an inability to take or retain fluids or oral medications, confusion, prostration, convulsions, respiratory distress, passing of red or cola-coloured urine (putative blackwater fever”)
•2. Severe anaemia (Hb <6 g/dL)
•3. Comorbid illness that requires treatment in hospital (physician’s judgement)
•4. Patients on drugs known to cause haemolysis in G6PDd e.g. dapsone, nalidixic acid
•5. Known to be allergic to PQ, AL, or DHAPP
•6. Previous enrolment in the current trial or current enrolment in another trial

发起方