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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06148480
Other study ID # IRB 2020-3331
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 17, 2020
Est. completion date December 31, 2026

Study information

Verified date November 2023
Source Ann & Robert H Lurie Children's Hospital of Chicago
Contact Mehreen Arshad
Phone 3122274668
Email marshad@luriechildrens.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

We aim to conduct a prospective surveillance study of mothers and their infants born vaginally or by scheduled C-section and who are admitted to Northwestern Medicine Prentice Women's Hospital to determine the prevalence of ESBL-E carriage in healthy post-partum women and the transmission rate of these strains to their infants. Using whole genome sequencing and a comparative genomics approach we will determine the relatedness of strains among mother-infant dyads as well as identify genetic regions common to transmitted strains. We hypothesize that; 1) given the diverse population of Chicago there will be a significant rate of gut colonization with ESBL-E among mothers admitted to Prentice, 2) ESBL-E strains isolated from neonates will be identical to those from their mothers and 3) genetic determinants of transmission are conserved across ESBL E. coli strains that are perinatally transmitted. These hypotheses will be tested using the following Aims: Aim 1: Determine the prevalence of ESBL-E gut colonization and rate of perinatal transmission among mother-infant dyads Aim 2: Identify genetic determinants of transmission common to ESBL E. coli that are perinatally transmitted. Our long-term goal is to understand the unique features of persistent gut and vaginal ESBL-E colonizers and identify genetic and molecular elements that could be attractive therapeutic targets to decrease the burden of ESBL-E colonization and perinatal transmission.


Description:

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Study Design


Locations

Country Name City State
United States Prentice Women's Hospital Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary ESBL-E Prevalence Determine the proportion of women in the post-partum period that are colonized with ESBL-E Baseline
Primary Transmission Among Mother-Infant Dyads Determine the proportion of neonates that acquire ESBL-E strains perinatally Baseline
Primary Persistence of ESBL-E Colonization For determine colonization of ESBL-E organisms in neonates 7 days after birth. 7 days from baseline
Secondary Genetic Determinants of ESBL-E Identifying specific genes that are important for successful perinatal transmission of ESBL-E Baseline
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