Multidrug Resistant Shigella Infection in Bangladesh

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Clinical and Microbiologic Outcomes in Patients Treated for Multidrug-resistant Shigella Infections in Dhaka, Bangladesh

Conditions
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Diarrhea, Shigella

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome: resolution of diarrhea | resolution of diarrhea as measured by the participant through a memory aid | Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiologic outcome: Shigella negative cultures | Proportion shigella culture negative isolates | Day 5 | 
| Proportion of patients that have complications | required hospitalization or have extraintestinal complications | day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multidrug resistant