Multidrug Resistant Shigella Infection in Bangladesh

NCT03778125 | Unknown

• 2 other identifiers: 21166PR-18078
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Conditions

Diarrhea; Shigella

Keywords

multidrug resistant

Outcome Measures

Primary Outcomes (1)

• Clinical outcome: resolution of diarrhea

  resolution of diarrhea as measured by the participant through a memory aid

  Day 5

Secondary Outcomes (2)

• Microbiologic outcome: Shigella negative cultures

  Day 5

• Proportion of patients that have complications

  day 5

Other Outcomes (4)

• time to last unformed stool

  Day 5

• fever

  Day 5

• bloody stool

  Day 5

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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). If WBC \> 10 HPF (4) 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.

You may qualify if:

• 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

You may not qualify if:

• Not receiving treatment with azithromycin at enrolment

Sponsors & Collaborators

• University of Virginia: lead
• Centers for Disease Control and Prevention: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research

Dhaka, Bangladesh

Location

Related Publications (1)

• 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.

  PMID: 32239137 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Stool culture positive for Shigella

MeSH Terms

Conditions

Diarrhea; Dysentery, Bacillary

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Dysentery; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Eric R Houpt, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jack Gwaltney Professor of Infectious Diseases

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 19, 2018
• Study Start: December 13, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: January 29, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)