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Multidrug Resistant Shigella Infection in Bangladesh

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状态
赞助商
University of Virginia
合作者
Centers for Disease Control and Prevention
International Centre for Diarrhoeal Disease Research, Bangladesh

关键词

抽象

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

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

Diarrhea
Shigella

-

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
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]

resolution of diarrhea as measured by the participant through a memory aid

次要成果指标

1. Microbiologic outcome: Shigella negative cultures [Day 5]

Proportion shigella culture negative isolates

2. Proportion of patients that have complications [day 5]

required hospitalization or have extraintestinal complications

其他成果措施

1. time to last unformed stool [Day 5]

duration of diarrhea in days

2. fever [Day 5]

duration of fever in days

3. bloody stool [Day 5]

duration of bloody stool in days

4. difference in invasion plasmid antigen H (ipaH) [Day 5]

molecular detection of Shigella quantity

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