ISRCTN49726849已完成1 期
Pharmacokinetics and Pharmacodynamics of azithromycin in severe malaria bacterial co-infection in African children
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37519413/ (added 31/07/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Children aged 6 months to 12 years at admission to hospital with Plasmodium falciparum malaria (on either blood film or ParacheckTM rapid diagnostic test)
- •2. Axillary temperature >380C or <360C
- •3. ‘Teule’ severity criteria: any one of the following: prostration; respiratory distress; severe anaemia (haemoglobin<5g/dL) or HIV infection
- •4. Parents willing/able to provide consent
排除标准
- •1. Major contraindications to azithromycin, eg strong existing clinical diagnosis of QT-prolongation
- •2. Concomitant use of interacting drugs: drugs that may cause QT-prolongation or drugs that may cause a pharmacokinetic interaction with azithromycin, like strong CYP3A/P-GP inducers and concomitantly administered antacids
研究者
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