Multidrug Resistant Shigella Infection in Bangladesh

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03778125
• Other study ID #: 21166
• Secondary ID: PR-18078
• Status: Enrolling by invitation
• Start date: December 13, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: January 2019
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Dysentery, Bacillary
• Shigella

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research	Dhaka

Sponsors (3)

Lead Sponsor	Collaborator
University of Virginia	Centers for Disease Control and Prevention, International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time to last unformed stool	duration of diarrhea in days	Day 5
Other	fever	duration of fever in days	Day 5
Other	bloody stool	duration of bloody stool in days	Day 5
Other	difference in invasion plasmid antigen H (ipaH)	molecular detection of Shigella quantity	Day 5
Primary	Clinical outcome: resolution of diarrhea	resolution of diarrhea as measured by the participant through a memory aid	Day 5
Secondary	Microbiologic outcome: Shigella negative cultures	Proportion shigella culture negative isolates	Day 5
Secondary	Proportion of patients that have complications	required hospitalization or have extraintestinal complications	day 5