Clinical and Microbiologic Outcomes in Patients Treated for Multidrug-resistant Shigella Infections in Dhaka, Bangladesh
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Clinical outcome: resolution of diarrhea
研究概览
简要总结
The purpose of this project is to systematically collect clinical and nutritional outcomes information on patients treated for Shigella infection so that physicians and clinical laboratories can better define which Shigella infections are "resistant" to antibiotics and which are "susceptible", focusing on azithromycin a last-line drug to treat drug resistant Shigella
详细描述
2000 suspected Shigella cases will be recruited from International Centre for Diarrhoeal Disease Research hospital, Dhaka who are presenting with diarrhea at the hospital. A stool sample will be collected from the participants after consenting by the study staff. Stool microscopy will be performed to see the white blood cells(WBC) and red blood cells (RBC). If WBC > 10 HPF (4) with any RBC present, culture will be performed from this stool to identify Shigella. Such patients with invasive diarrhea are treated with azithromycin per local standard of care. Enrolled participant will be invited for further follow up when culture from the stool is Shigella positive. Minimal inhibitory concentration (MIC) testing of Shigella isolates and Molecular testing of Shigella isolates will be performed from Shigella cultures. This is an observational study. This study does not provide any treatment to the study participants; they will receive treatment as per International Centre for Diarrhoeal Disease Research Dhaka hospital guidelines. We will then examine the effect of the azithromycin minimal inhibitory concentration on clinical outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diarrheal illness less than 96 hours duration
- •microscopic evidence of inflammatory diarrhea
- •plus mucus in stool
- •plus abdominal pain/cramps
- •Subject or parents or legal guardian willing to come for follow up at hospital or allow study staff for home visit
- •residence in Dhaka region
- •presentation during daytime hours
排除标准
- •Not receiving treatment with azithromycin at enrolment
结局指标
主要结局
Clinical outcome: resolution of diarrhea
时间窗: Day 5
resolution of diarrhea as measured by the participant through a memory aid
次要结局
- Proportion of patients that have complications(day 5)
- Microbiologic outcome: Shigella negative cultures(Day 5)
研究者
Eric R. Houpt, MD
Jack Gwaltney Professor of Infectious Diseases
University of Virginia