Multidrug Resistant Shigella Infection in Bangladesh
关键词
抽象
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.
日期
最后验证: | 12/31/2018 |
首次提交: | 12/11/2018 |
提交的预估入学人数: | 12/12/2018 |
首次发布: | 12/18/2018 |
上次提交的更新: | 01/24/2019 |
最近更新发布: | 01/28/2019 |
实际学习开始日期: | 12/12/2018 |
预计主要完成日期: | 12/30/2019 |
预计完成日期: | 01/30/2020 |
状况或疾病
相
资格标准
有资格学习的性别 | All |
取样方式 | Probability Sample |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - 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 Exclusion Criteria: • Not receiving treatment with azithromycin at enrolment |
结果
主要结果指标
1. Clinical outcome: resolution of diarrhea [Day 5]
次要成果指标
1. Microbiologic outcome: Shigella negative cultures [Day 5]
2. Proportion of patients that have complications [day 5]
其他成果措施
1. time to last unformed stool [Day 5]
2. fever [Day 5]
3. bloody stool [Day 5]
4. difference in invasion plasmid antigen H (ipaH) [Day 5]