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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Thrasher Research Fund
Northwestern Memorial Hospital
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00532324
First received: September 19, 2007
Last updated: March 10, 2011
Last verified: April 2009
  Purpose

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.


Condition Intervention
Staphylococcus Aureus Infection
Other: CA-MRSA Decolonization

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

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. [ Time Frame: We will obtain vaginal and nasal samples at the 34-36 week gestation OB/Gyn visit. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

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. [ 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: January 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A
Pregnant women not receiving CA-MRSA decolonization therapy.
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

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532324

Contacts
Contact: Tina Q Tan, M.D. 773-880-4187 titan@childrensmemorial.org

Locations
United States, Illinois
Prentice Women's Hospital and Maternity Center of Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Tina Q Tan, M.D.    773-880-4187    titan@childrensmemorial.org   
Principal Investigator: Tina Q Tan, M.D.         
Sub-Investigator: Ami Patel, B.S.         
Sub-Investigator: Alan Peaceman         
Principal Investigator: Latania K Logan, M.D.         
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
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
  More Information

Publications:
Responsible Party: Tina Tan, MD/Associate Professor of Pediatrics, Children's Memorial Hospital/McGaw Medical Center of Northwestern University
ClinicalTrials.gov Identifier: NCT00532324     History of Changes
Other Study ID Numbers: 2007-13145(CMH)/2623-001(NU)
Study First Received: September 19, 2007
Last Updated: March 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Methicillin resistant Staphylococcus aureus
Staphylococcus aureus
Healthy term and near term neonates
Prevention
Nasal and Vaginal Colonization rates
Pregnant women

Additional relevant MeSH terms:
Staphylococcal Infections
Communicable Diseases
Infection
Bacterial Infections
Gram-Positive Bacterial Infections
Chlorhexidine
Methicillin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014