- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06148480
Perinatal Transmission of MDR Bacteria (ACQUIRE)
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.
Study Overview
Status
Conditions
Detailed Description
The rapid rise of multi-drug resistant Enterobacteriaceae (MDR-E) is severely threatening the way we treat common infectious diseases. A particularly vulnerable population are neonates where a delay in the treatment of MDR-E sepsis can be fatal. Additionally, highly drug resistant bacteria such as the pandemic E. coli ST131 strain are persistent gut and vaginal colonizers (1). In animal models of gut colonization, these strains out-compete drug-sensitive, commensal Escherichia coli. Early life exposure to MDR-E could, therefore, have long-lasting effects on the developing microbiome and overall child health (2).
Among extra-intestinal pathogenic Enterobacteriaceae, resistance against a number of antibiotics, especially the beta-lactams, has rapidly risen in the last decade. Since the gut is a major reservoir of these pathogens even in otherwise healthy individuals it is likely that there is a concomitant increase in gut colonization with extended spectrum beta-lactamase producing Enterobacteriaceae (ESBL-E) among the general population (3, 4). Even in regions with a low prevalence of community acquired ESBL-E infections, perinatal transmission occurs in 35% of infants born to mothers colonized with these strains (5). We and others have recently shown that healthy infants in South Asia, a region with a high use of antibiotics per capita, are carriers of ESBL-E (6). In vitro studies in our lab suggest that ESBL E. coli isolated from these infants have a higher growth potential than commensal E. coli. Using a murine model of perinatal transmission of E. coli, we have shown that some of the ESBL E. coli strains adept in human infant gut colonization can also readily colonize pregnant dams and be perinatally transmitted. The burden of ESBL-E colonization among pregnant women and their neonates in the US and the genetic determinants of perinatal transmission are unknown.
We aim to conduct a prospective surveillance study of mothers and their infants born vaginally 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mehreen Arshad
- Phone Number: 3122274668
- Email: marshad@luriechildrens.org
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Recruiting
- Prentice Women's Hospital
-
Contact:
- Sebastian Otero
- Phone Number: 312-227-4668
- Email: sotero@lureichildrens.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Mother-Infant Dyads
Women and their neonates admitted to the postpartum floor will be enrolled after being screened for the exclusion criteria
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ESBL-E Prevalence
Time Frame: Baseline
|
Determine the proportion of women in the post-partum period that are colonized with ESBL-E
|
Baseline
|
Transmission Among Mother-Infant Dyads
Time Frame: Baseline
|
Determine the proportion of neonates that acquire ESBL-E strains perinatally
|
Baseline
|
Persistence of ESBL-E Colonization
Time Frame: 7 days from baseline
|
For determine colonization of ESBL-E organisms in neonates 7 days after birth.
|
7 days from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Genetic Determinants of ESBL-E
Time Frame: Baseline
|
Identifying specific genes that are important for successful perinatal transmission of ESBL-E
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mehree Arshad, MD, Lurie Children's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 2020-3331
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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