A Prospective Cohort Pilot Study of the Clinical and Molecular Epidemiology of Staphylococcus Aureus in Pregnant Women at the Time of Group B Streptococcal Screening in a Large Urban Medical Center in Chicago, IL USA

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:

1. 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.
2. Pregnant women colonized with CA-MRSA are at higher risk for post-partum infection with this organism.

Specific Aims:

1. To determine the incidence of nasal and vaginal colonization with CA-MRSA in pregnant women and determine the genetic similarities of these strains.
2. To study CA-MRSA transmission dynamics and evaluate the incidence of SSTI and invasive infections in newborns born to S. aureus colonized mothers.
3. 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.

Conditions

• Staphylococcus Aureus

Interventions

OTHER

CA-MRSA Decolonization

In later stages of this study, women found to be nasally and/or vaginally colonized with CA-MRSA will be randomized to receive postpartum, either: 1) attempted decolonization with intranasal mupirocin twice a day for one to two weeks with or without diluted chlorhexidine or Clorox baths two to three times a week for one to two weeks or, 2) no intervention. The primary study is observational only.

Sponsors & Collaborators

• Thrasher Research Fund

  collaborator OTHER

• Northwestern Memorial Hospital

  collaborator OTHER

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

  lead OTHER

Principal Investigators

• Tina Q Tan, M.D. · Children's Memorial Hospital/Northwestern University Feinberg School of Medicine

• Latania K Logan, M.D. · Children's Memorial Hospital/Northwestern University Feinberg School of Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-02-29

Primary Completion

2009-06-30

Completion

2013-10-31

Countries

• United States

Study Locations