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

Sponsor:	Children's Memorial Hospital
Collaborators:	Thrasher Research Fund Northwestern Memorial Hospital
Information provided by:	Children's Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00532324

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:

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.

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:

Drug Information available for: Chlorhexidine Mupirocin Chlorhexidine gluconate Staphylococcus aureus Hibiclens Mupirocin calcium

U.S. FDA Resources

Further study details as provided by Children's Memorial Hospital:

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

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

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

Children's Memorial Hospital

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:

Kollef MH, Micek ST. Methicillin-resistant Staphylococcus aureus: a new community-acquired pathogen? Curr Opin Infect Dis. 2006 Apr;19(2):161-8. Review.

Crawford SE, Daum RS. Epidemic community-associated methicillin-resistant Staphylococcus aureus: modern times for an ancient pathogen. Pediatr Infect Dis J. 2005 May;24(5):459-60. Review. No abstract available.

Deresinski S. Methicillin-resistant Staphylococcus aureus: an evolutionary, epidemiologic, and therapeutic odyssey. Clin Infect Dis. 2005 Feb 15;40(4):562-73. Epub 2005 Jan 24. Review.

Fortunov RM, Hulten KG, Hammerman WA, Mason EO Jr, Kaplan SL. Community-acquired Staphylococcus aureus infections in term and near-term previously healthy neonates. Pediatrics. 2006 Sep;118(3):874-81.

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 Children's Memorial Hospital:

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
Gram-Positive Bacterial Infections
Bacterial Infections
Chlorhexidine
Chlorhexidine gluconate
Methicillin
Mupirocin
Anti-Infective Agents, Local
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2012