Perinatal Transmission of MDR Bacteria

NCT06148480 | Recruiting

• 1 other identifier: IRB 2020-3331
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

E. Coli Infection; Multi-antibiotic Resistance

Outcome Measures

Primary Outcomes (3)

• ESBL-E Prevalence

  Determine the proportion of women in the post-partum period that are colonized with ESBL-E

  Baseline

• Transmission Among Mother-Infant Dyads

  Determine the proportion of neonates that acquire ESBL-E strains perinatally

  Baseline

• Persistence of ESBL-E Colonization

  For determine colonization of ESBL-E organisms in neonates 7 days after birth.

  7 days from baseline

Secondary Outcomes (1)

• Genetic Determinants of ESBL-E

  Baseline

Study Arms (1)

Mother-Infant Dyads

Women and their neonates admitted to the postpartum floor will be enrolled after being screened for the exclusion criteria

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mothers and their infants born vaginally or by scheduled c-section and who are admitted to Northwestern Medicine Prentice Women's Hospital

You may qualify if:

• 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.
• Infants that are born vaginally who are healthy and do not require transfer to the NICU for any reason.

You may not qualify if:

• Temperature \>38 Celsius in labor
• Caesarean section after labor
• Rupture of membranes or done emergently
• Antibiotic use in last trimester including for GBS+
• Delivery at \<35 weeks
• Immunocompromised host including being HIV+
• Infant requiring transfer to NICU for any reason and infants who are transferred to the NICU.

Sponsors & Collaborators

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

Study Sites (1)

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Mothers will be asked to self-collect perineal (x2) and rectal swabs (x2) while they are admitted in the hospital. Infant stool samples will be collected between the first 24-48 hrs. of life. We will also be collecting infant stool samples at day 7 of life (+/- 2 days).

MeSH Terms

Conditions

Escherichia coli Infections

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Mehree Arshad, MD

  Lurie Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehreen Arshad

CONTACT

3122274668; marshad@luriechildrens.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: July 17, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

US (1)