Community-Acquired Methicillin Resistant Staphylococcus Aureus Colonization in Pregnant Women and Infections in Newborns
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|ClinicalTrials.gov Identifier: NCT00532324|
Recruitment Status : Unknown
Verified April 2009 by Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was: Recruiting
First Posted : September 20, 2007
Last Update Posted : March 11, 2011
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.
- 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.
- 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.
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 or disease||Intervention/treatment||Phase|
|Staphylococcus Aureus Infection||Other: CA-MRSA Decolonization||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2008|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||January 2010|
No Intervention: A
Pregnant women not receiving CA-MRSA decolonization therapy.
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.
- 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. ]
- 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. ]
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532324
|Contact: Tina Q Tan, M.D.||firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Tina Q Tan, M.D.|
|Sub-Investigator: Ami Patel, B.S.|
|Sub-Investigator: Alan Peaceman|
|Principal Investigator: Latania K Logan, M.D.|
|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|