CTRI/2021/10/037047尚未招募4 期
A comparison of concomitant administration of Azithromycin and Cefixime to Azithromycin alone in the treatment of Typhoid - ACT South Asia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. A history of fever at presentation for 72 hours or more and a documented fever (37.5 degrees Celsius or more(axillary) or 38degree Celsius or more(oral))
- •2. Age 2 years or more (and weight 10kg and more) to 65 years
- •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 or more
- •5. Able to take oral treatment
- •6. Able to attend for follow-up and can be contacted by telephone
- •7. 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, hemodynamic 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 five 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 antidepressants, or anticonvulsants) that may also cause prolonged QT interval
- •13. PCR positive for Co-Vid 19 before or after randomization
研究者
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