Staphylococcus Aureus Infection Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | January 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Prentice Women's Hospital and Maternity Center of Northwestern Memorial Hospital | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Ann & Robert H Lurie Children's Hospital of Chicago | Northwestern Memorial Hospital, Thrasher Research Fund |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Kollef MH, Micek ST. Methicillin-resistant Staphylococcus aureus: a new community-acquired pathogen? Curr Opin Infect Dis. 2006 Apr;19(2):161-8. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | We will obtain vaginal and nasal samples at the 34-36 week gestation OB/Gyn visit. | No | |
Primary | 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. | Infants born to CA-MRSA colonized mothers will be followed for CA-MRSA colonization and/or SSTIs for the first 4 weeks of life. | No | |
Secondary | 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. | Infants born to CA-MRSA colonized moms will be followed for CA-MRSA colonization and/or SSTIs for the first 4 weeks of life. | No |
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