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Multidrug Resistant Shigella Infection in Bangladesh

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ClinicalTrials.gov Identifier: NCT03778125
Recruitment Status : Enrolling by invitation
First Posted : December 18, 2018
Last Update Posted : January 29, 2019
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Eric R. Houpt, MD, 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

Condition or disease
Diarrhea 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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical and Microbiologic Outcomes in Patients Treated for Multidrug-resistant Shigella Infections in Dhaka, Bangladesh
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea




Primary Outcome Measures :
  1. Clinical outcome: resolution of diarrhea [ Time Frame: Day 5 ]
    resolution of diarrhea as measured by the participant through a memory aid


Secondary Outcome Measures :
  1. Microbiologic outcome: Shigella negative cultures [ Time Frame: Day 5 ]
    Proportion shigella culture negative isolates

  2. Proportion of patients that have complications [ Time Frame: day 5 ]
    required hospitalization or have extraintestinal complications


Other Outcome Measures:
  1. time to last unformed stool [ Time Frame: Day 5 ]
    duration of diarrhea in days

  2. fever [ Time Frame: Day 5 ]
    duration of fever in days

  3. bloody stool [ Time Frame: Day 5 ]
    duration of bloody stool in days

  4. difference in invasion plasmid antigen H (ipaH) [ Time Frame: Day 5 ]
    molecular detection of Shigella quantity


Biospecimen Retention:   Samples With DNA
Stool culture positive for Shigella


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778125


Locations
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Bangladesh
International Centre for Diarrhoeal Disease Research
Dhaka, Bangladesh
Sponsors and Collaborators
University of Virginia
Centers for Disease Control and Prevention
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
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Principal Investigator: Eric R Houpt, MD University of Virginia

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Responsible Party: Eric R. Houpt, MD, Jack Gwaltney Professor of Infectious Diseases, University of Virginia
ClinicalTrials.gov Identifier: NCT03778125     History of Changes
Other Study ID Numbers: 21166
PR-18078 ( Other Identifier: International Centre for Diarrhoeal Disease Research )
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eric R. Houpt, MD, University of Virginia:
multidrug resistant

Additional relevant MeSH terms:
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Diarrhea
Dysentery, Bacillary
Signs and Symptoms, Digestive
Signs and Symptoms
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Dysentery
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases