Clinical trial NCT03778125: Multidrug Resistant Shigella Infection in Bangladesh
Official title: Clinical and Microbiologic Outcomes in Patients Treated for Multidrug-resistant Shigella Infections in Dhaka, Bangladesh
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diarrhea
Shigella
Keywords: multidrug resistant
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2018-12-19
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Clinical outcome: resolution of diarrhea
timeFrame: Day 5
Secondary outcomes:
measure: Microbiologic outcome: Shigella negative cultures
timeFrame: Day 5
measure: Proportion of patients that have complications
timeFrame: day 5
Other outcomes:
measure: time to last unformed stool
timeFrame: Day 5
measure: fever
timeFrame: Day 5
measure: bloody stool
timeFrame: Day 5
measure: difference in invasion plasmid antigen H (ipaH)
timeFrame: Day 5
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research
Study officials:
affiliation: University of Virginia
name: Eric R Houpt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.