Multi-antibiotic Resistance Clinical Trial
— ACQUIREOfficial title:
Perinatal Transmission of Multi-drug Resistant (MDR) Bacteria
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 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. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
United States | Prentice Women's Hospital | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Ann & Robert H Lurie Children's Hospital of Chicago |
United States,
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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