NCT03778125

Multidrug Resistant Shigella Infection in Bangladesh

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Diarrhea
• Shigella

Timeline

• Start date: 2018-12-13
• Primary completion: 2019-12-31
• Completion: 2020-01-31
• First posted: 2018-12-19
• Last updated: 2019-01-29

Locations

1 site across 1 country: Bangladesh