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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
| Northwestern Memorial Hospital | OTHER |
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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:
Specific Aims:
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.
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:
Methods:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | No Intervention | Pregnant women not receiving CA-MRSA decolonization therapy. | |
| B | Other | Pregnant women receiving CA-MRSA decolonization therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CA-MRSA Decolonization | Other | 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. |
| Measure | Description | 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. | 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. | Infants born to CA-MRSA colonized mothers will be followed for CA-MRSA colonization and/or SSTIs for the first 4 weeks of life. |
| Measure | Description | 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. | Infants born to CA-MRSA colonized moms will be followed for CA-MRSA colonization and/or SSTIs for the first 4 weeks of life. |
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Inclusion Criteria:
Exclusion Criteria:
Age limits for infants will be 0-4 weeks of age and both genders will be included.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prentice Women's Hospital and Maternity Center of Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16514341 | Background | Kollef MH, Micek ST. Methicillin-resistant Staphylococcus aureus: a new community-acquired pathogen? Curr Opin Infect Dis. 2006 Apr;19(2):161-8. doi: 10.1097/01.qco.0000216627.13445.e2. | |
| 15876949 | Background | 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. doi: 10.1097/01.inf.0000164170.67897.97. No abstract available. |
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| 15712079 | Background | Deresinski S. Methicillin-resistant Staphylococcus aureus: an evolutionary, epidemiologic, and therapeutic odyssey. Clin Infect Dis. 2005 Feb 15;40(4):562-73. doi: 10.1086/427701. Epub 2005 Jan 24. |
| 16950976 | Background | 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. doi: 10.1542/peds.2006-0884. |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D016712 | Mupirocin |
| D014260 | Triclosan |
| D012973 | Sodium Hypochlorite |
| ID | Term |
|---|---|
| D004852 | Epoxy Compounds |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D006997 | Hypochlorous Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D017670 | Sodium Compounds |
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