Multidrug Resistant Shigella Infection in Bangladesh

• Conditions: Shigella; Diarrhea

• Registration Number: NCT03778125
• Lead Sponsor: University of Virginia

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-12-12
• Study Start: 2018-12-13
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-19
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-29
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical outcome: resolution of diarrhea	Day 5	resolution of diarrhea as measured by the participant through a memory aid

Secondary Outcome Measures

Name	Time	Method
Proportion of patients that have complications	day 5	required hospitalization or have extraintestinal complications
Microbiologic outcome: Shigella negative cultures	Day 5	Proportion shigella culture negative isolates

Trial Locations

Locations (1)

International Centre for Diarrhoeal Disease Research; 🇧🇩 Dhaka, Bangladesh