ISRCTN18065452进行中（未招募）4 期
Azithromycin and cefixime combination versus azithromycin alone for the out-patient treatment of clinically suspected or confirmed uncomplicated typhoid fever in South Asia; a randomized controlled trial (ACT-South Asia Trial)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35097222/ (added 03/07/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. A history of fever at presentation for >48 hours and a documented fever(=37.5oC (axillary))
- •2. Aged =2 years (and =10 kg) to 65 years old
- •3. No clear focus of infection on initial clinical evaluation
- •4. Malaria RDT negative; dengue NS1 RDT negative; scrub typhus RDT negative; CRP rapid test =10 mg/L. Able to take oral treatment ( Exception case if any Of RDT is positive or CRP< 10, but blood/stool culture positive case).
- •5. Able to attend for follow-up and can be contacted by telephone
- •6. Written fully informed consent to participate in the study including assent for children in addition to parental/legal guardian consent
排除标准
- •1. History of fever for >14 days
- •2. Pregnant or positive pregnancy test or breast-feeding
- •3. Presence of clinical symptoms or signs indicating a focal infection such as pneumonia; urinary infection, meningitis, eschar
- •4. Obtundation, haemodynamic shock, visible jaundice, gastrointestinal bleeding or any signs of severe disease that may require immediate hospitalization
- •5. Being treated for TB or HIV or severe acute malnutrition
- •6. Patients with cardiac disease
- •7. Patient requiring intravenous antibiotics for any reason
- •8. Previous history of hypersensitivity to any of the treatment options
- •9. Either of the trial drugs are contraindicated for any reason (e.g. drug interactions)
- •10. Has received azithromycin or cefixime in the last 5 days
- •11. Receiving another antimicrobial and responding clinically to the treatment as judged by the attending clinician.
- •12. Being on another drug (for example certain kinds of anti-depressants, or anticonvulsants) that may also cause prolonged QT interval
- •13. COVID-19 PCR/antigen positive
研究者
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