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B for Staph Infection

N/A
Waitlist Available
Led By Tina Q Tan, M.D.
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up we will obtain vaginal and nasal samples at the 34-36 week gestation ob/gyn visit.
Awards & highlights

Study Summary

Background: Community acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) is an emerging pathogen of the 21st century whose incidence as a cause of local and invasive infections has significantly increased, especially in previously healthy term and near term newborns. The etiology of the increasing incidence of infection in previously healthy term and near-term newborns remains unclear. Hypothesis: The incidence of previously healthy newborns infected with CA-MRSA skin & soft tissue (SSTI) and invasive infections is higher in those born to mothers colonized with CA-MRSA. Pregnant women colonized with CA-MRSA are at higher risk for post-partum infection with this organism. Specific Aims: To determine the incidence of nasal and vaginal colonization with CA-MRSA in pregnant women and determine the genetic similarities of these strains. To study CA-MRSA transmission dynamics and evaluate the incidence of SSTI and invasive infections in newborns born to S. aureus colonized mothers. To study the efficacy of attempted decolonization in CA-MRSA colonized mothers in decreasing the incidence of transmission and development of SSTI and invasive infections in their infants during the first month of life. Potential Impact: Understanding the epidemiology of the transmission dynamics of CA-MRSA in previously healthy newborns will provide important information to support the development of strategies aimed at the interruption of transmission and prevention of infection caused by CA-MRSA in newborns, as well as in pregnant women. This will also allow for the development of infection control strategies to prevent the spread of this organism among post-partum units and nurseries.

Eligible Conditions
  • Staph Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~we will obtain vaginal and nasal samples at the 34-36 week gestation ob/gyn visit.
This trial's timeline: 3 weeks for screening, Varies for treatment, and we will obtain vaginal and nasal samples at the 34-36 week gestation ob/gyn visit. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CA-MRSA vaginal and nasal colonization rates in pregnant women at the time of routine Group B Streptococcus (GBS) Screening at 34-36 week gestation visit.
The incidence of CA-MRSA skin, soft tissue and invasive (SSTI) infections in healthy term and near-term infants born to CA-MRSA colonized mothers.
Secondary outcome measures
In later stages of the study, we will study the efficacy of attempted decolonization in CA-MRSA colonized mothers in decreasing the incidence of transmission and development of SSTI and invasive infections in their infants during the first month of life.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BExperimental Treatment1 Intervention
Pregnant women receiving CA-MRSA decolonization therapy.
Group II: AActive Control1 Intervention
Pregnant women not receiving CA-MRSA decolonization therapy.

Find a Location

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
258 Previous Clinical Trials
5,187,630 Total Patients Enrolled
Thrasher Research FundOTHER
132 Previous Clinical Trials
92,874 Total Patients Enrolled
Northwestern Memorial HospitalOTHER
40 Previous Clinical Trials
15,216 Total Patients Enrolled

Frequently Asked Questions

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~87 spots leftby Apr 2025