Community-Acquired Methicillin Resistant Staphylococcus Aureus Colonization in Pregnant Women and Infections in Newborns

March 10, 2011 updated by: Ann & Robert H Lurie Children's Hospital of Chicago

Community-Acquired Methicillin Resistant Staphylococcus Aureus (CA-MRSA) Vaginal and Nasal Colonization in Pregnant Women and Frequency of CA-MRSA Infections in Previously Healthy Term and Near-Term Neonates

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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 neonates where it may be associated with high morbidity and mortality(1, 2, 3). The etiology for this increase remains unclear, but may be a consequence of perinatal or postnatal acquisition via maternal transmission through skin, breast milk, or vaginal colonization(4).

The major goals of our study are: to determine the incidence of pregnant women who are colonized with CA-MRSA, gain a better understanding of the transmission dynamics of this organism between the mother and the newborn infant, and to develop strategies for the prevention of transmission, spread and infection with this organism in both these populations.

This staged study is a collaborative effort between investigators from the Children's Memorial Hospital Division of Infectious Diseases, Northwestern Memorial Hospital Department of Obstetrics and Gynecology, and the Northwestern Memorial Hospital Division of Infectious Diseases. Collaboration across multiple specialties provides strength to the study by allowing the investigators to address multiple issues that are pertinent to both the care of pregnant mothers and newborn infants in the inpatient and outpatient setting.

Hypothesis:

1. The incidence of previously healthy term and near-term neonates infected with CA-MRSA skin & soft tissue (SSTI) and invasive infections is higher in those born to mothers vaginally and/or nasally colonized with CA-MRSA and, 2. Pregnant women vaginally and/or nasally 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 clonality of these strains.
  2. To study CA-MRSA transmission dynamics and evaluate the incidence of SSTI and invasive infections in term and near-term newborns born to S. aureus vaginal and/or nasal 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.

Methods:

  1. Vaginal and anterior nasal cultures will be obtained prospectively over several months from pregnant women who obtain their prenatal care through Obstetrical practices at Prentice Women's Hospital and Maternity Center of Northwestern Memorial Hospital during the time of GBS screening at 34-36 weeks gestation. Together, these practices account for 300-500 deliveries per month.
  2. Cultures will be plated on blood agar and incubated at 37oC for 48 hours. S. aureus strains will be identified by colony morphology and latex agglutination. MRSA isolates will be identified by PCR or latex agglutination for penicillin binding protein 2a by detecting the mecA gene and clonality by PFGE. PCR testing will then be used to identify strains carrying the Panton-Valentine Leukocidin gene as a marker of virulence.
  3. In a prospective case-control cohort study, newborns born to CA-MRSA colonized mothers will have anterior nares cultures for S. aureus obtained at birth and followed for the development of SSTI and invasive infections for one month. Samples positive for MRSA will be tested for similarities to maternal isolates through methods described above. The newborn incidence of MRSA infection will be compared between those born to non-colonized mothers and those born to colonized mothers.
  4. In further 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 with or without diluted chlorhexidine or Clorox baths or, 2) no intervention.

Potential Impact:

Understanding the epidemiology of the transmission dynamics of CA-MRSA in previously healthy neonates 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 this patient population, as well as in pregnant women. This will also allow for the development of infection control strategies in the hospital setting to prevent the spread of this organism among post-partum units and nurseries.

Study Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Prentice Women's Hospital and Maternity Center of Northwestern Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Tina Q Tan, M.D.
        • Sub-Investigator:
          • Ami Patel, B.S.
        • Sub-Investigator:
          • Alan Peaceman
        • Principal Investigator:
          • Latania K Logan, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy pregnant women who present for routine OB/GYN care during the of the 34-36 week gestation GBS screening visit.
  • Healthy term and near-term infants born to these mothers

Exclusion Criteria:

  • Pre-term infants
  • Infants who had significant illness after birth, i.e. transferred to neonatal intensive care unit for significant illness.

Age limits for infants will be 0-4 weeks of age and both genders will be included.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: A
Pregnant women not receiving CA-MRSA decolonization therapy.
Other: B
Pregnant women receiving CA-MRSA decolonization therapy.
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.
Other Names:
  • Mupirocin also known as Bactroban
  • Chlorhexidine also known as Phisohex, Clorox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: We will obtain vaginal and nasal samples at the 34-36 week gestation OB/Gyn visit.
We will obtain vaginal and nasal samples at the 34-36 week gestation OB/Gyn 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.
Time Frame: Infants born to CA-MRSA colonized mothers will be followed for CA-MRSA colonization and/or SSTIs for the first 4 weeks of life.
Infants born to CA-MRSA colonized mothers will be followed for CA-MRSA colonization and/or SSTIs for the first 4 weeks of life.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Infants born to CA-MRSA colonized moms will be followed for CA-MRSA colonization and/or SSTIs for the first 4 weeks of life.
Infants born to CA-MRSA colonized moms will be followed for CA-MRSA colonization and/or SSTIs for the first 4 weeks of life.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborators

Thrasher Research Fund
Northwestern Memorial Hospital

Investigators

  • Principal Investigator: Tina Q Tan, M.D., Children's Memorial Hospital/Northwestern University Feinberg School of Medicine
  • Principal Investigator: Latania K Logan, M.D., Children's Memorial Hospital/Northwestern University Feinberg School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

September 19, 2007

First Submitted That Met QC Criteria

September 19, 2007

First Posted (Estimate)

September 20, 2007

Study Record Updates

Last Update Posted (Estimate)

March 11, 2011

Last Update Submitted That Met QC Criteria

March 10, 2011

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-13145(CMH)/2623-001(NU)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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