DiarrheaNCT03778125
Multidrug Resistant Shigella Infection in Bangladesh
An observational study of Diarrhea and Shigella, run by University of Virginia at 1 site in Bangladesh.
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… Read more about this study
- Who is it for?
- Any age
- How many people
- 2,000 participants
- Where
- 1 siteBangladesh
- Study dates
- 13 Dec 2018to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Not receiving treatment with azithromycin at enrolment
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research
Dhaka
About this study
Official title: Clinical and Microbiologic Outcomes in Patients Treated for Multidrug-resistant Shigella Infections in Dhaka, Bangladesh
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
Read the 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.
- Keywords
- multidrug resistant
- Medical subject headings
- Diarrhea, Dysentery, Bacillary
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome: resolution of diarrhea
resolution of diarrhea as measured by the participant through a memory aid
Measured: Day 5
Secondary outcomes (2)
Microbiologic outcome: Shigella negative cultures
Proportion shigella culture negative isolates
Measured: Day 5
Proportion of patients that have complications
required hospitalization or have extraintestinal complications
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start13 Dec 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Principal investigator, Eric R. Houpt, MD, University of Virginia
- Investigators
- Eric R Houpt, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778125
- Sponsor's protocol ID
- 21166
- Other IDs
- PR-18078
- Status last verified
- Jan 2019
- First submitted
- 12 Dec 2018
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32239137
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiologic Outcomes in Patients Treated for Multidrug-resistant Shigella Infections in Dhaka, Bangladesh
- ClinicalTrials.gov ID
- NCT03778125
- Acronym / sponsor ID
- 21166
- Keywords
- multidrug resistant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Not receiving treatment with azithromycin at enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical outcome: resolution of diarrhea
Time frame: Day 5
resolution of diarrhea as measured by the participant through a memory aid
2 secondary outcomes
Microbiologic outcome: Shigella negative cultures
Time frame: Day 5
Proportion of patients that have complications
Time frame: day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Derived from this study: PubMed 32239137Houpt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric R Houpt, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea and Shigella, run by University of Virginia at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome: resolution of diarrhea (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03778125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.