RECRUITING

Perinatal Transmission of MDR Bacteria

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators 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 the investigators will determine the relatedness of strains among mother-infant dyads as well as identify genetic regions common to transmitted strains. It is 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. The 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.

Official Title

Perinatal Transmission of Multi-drug Resistant (MDR) Bacteria

Quick Facts

Study Start:2020-07-17
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06148480

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women that are admitted to Northwestern Medicine Women's Hospital that have delivered an infant vaginally or have had a scheduled C-section without preceding labor.
  2. * Infants that are born vaginally who are healthy and do not require transfer to the NICU for any reason.
  1. * Temperature \>38 Celsius in labor
  2. * Caesarean section after labor
  3. * Rupture of membranes or done emergently
  4. * Antibiotic use in last trimester including for GBS+
  5. * Delivery at \<35 weeks
  6. * Immunocompromised host including being HIV+
  7. * Infant requiring transfer to NICU for any reason and infants who are transferred to the NICU.

Contacts and Locations

Study Contact

Mehreen Arshad
CONTACT
3122274668
marshad@luriechildrens.org

Principal Investigator

Mehree Arshad, MD
PRINCIPAL_INVESTIGATOR
Lurie Children's Hospital

Study Locations (Sites)

Prentice Women's Hospital
Chicago, Illinois, 60611
United States

Collaborators and Investigators

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

  • Mehree Arshad, MD, PRINCIPAL_INVESTIGATOR, Lurie Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-17
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2020-07-17
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • E. Coli Infection
  • Multi-antibiotic Resistance