Multidrug Resistant Shigella Infection in Bangladesh
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| ClinicalTrials.gov Identifier: NCT03778125 |
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Recruitment Status : Unknown
Verified January 2019 by Eric R. Houpt, MD, University of Virginia.
Recruitment status was: Enrolling by invitation
First Posted : December 19, 2018
Last Update Posted : January 29, 2019
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Sponsor:
University of Virginia
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
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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 |
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.
| 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 |
Primary Outcome Measures :
- Clinical outcome: resolution of diarrhea [ Time Frame: Day 5 ]resolution of diarrhea as measured by the participant through a memory aid
Secondary Outcome Measures :
- Microbiologic outcome: Shigella negative cultures [ Time Frame: Day 5 ]Proportion shigella culture negative isolates
- Proportion of patients that have complications [ Time Frame: day 5 ]required hospitalization or have extraintestinal complications
Other Outcome Measures:
- time to last unformed stool [ Time Frame: Day 5 ]duration of diarrhea in days
- fever [ Time Frame: Day 5 ]duration of fever in days
- bloody stool [ Time Frame: Day 5 ]duration of bloody stool in days
- 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
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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
| 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
| Principal Investigator: | Eric R Houpt, MD | University of Virginia |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eric R. Houpt, MD, Jack Gwaltney Professor of Infectious Diseases, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT03778125 |
| Other Study ID Numbers: |
21166 PR-18078 ( Other Identifier: International Centre for Diarrhoeal Disease Research ) |
| First Posted: | December 19, 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 |
| 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:
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multidrug resistant |
Additional relevant MeSH terms:
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Dysentery, Bacillary Diarrhea Infections Signs and Symptoms, Digestive Enterobacteriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
Bacterial Infections and Mycoses Dysentery Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |