Multidrug Resistant Shigella Infection in Bangladesh | NCT03778125

Studies
Multidrug Resistant Shigella Infection in Bangladesh

NCT03778125

Sponsor

University of Virginia

Status

Unknown status

Last Update Posted

Jan 29, 2019Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Diarrhea
Shigella

Interventions

Not provided

Countries

Bangladesh

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PR-18078	Other Identifier	International Centre for Diarrhoeal Disease Research

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 13, 2018Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Jan 31, 2020Estimated

First Submitted Date

Dec 12, 2018

First Submission Date that Met QC Criteria

Dec 13, 2018

First Posted Date

Dec 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2019

Last Update Posted Date

Jan 29, 2019Actual

Name	Class
Centers for Disease Control and Prevention	FED
International Centre for Diarrhoeal Disease Research, Bangladesh	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
time to last unformed stool	duration of diarrhea in days	Day 5
fever	duration of fever in days	Day 5

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Sampling Method

Probability Sample

Name	Affiliation	Role
Eric R Houpt, MD	University of Virginia	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32239137	Derived	Houpt ER, Ferdous T, Ara R, Ibrahim M, Alam MM, Kabir M, Platts-Mills J, Ahmed T, Faruque ASG, Taniuchi M, Haque R. Clinical Outcomes of Drug-resistant Shigellosis Treated With Azithromycin in Bangladesh. Clin Infect Dis. 2021 May 18;72(10):1793-1798. doi: 10.1093/cid/ciaa363.

ID	Term
D003967	Diarrhea
D004405	Dysentery, Bacillary

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D004756	Enterobacteriaceae Infections