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Sponsors and Collaborators: |
Children's Memorial Hospital Thrasher Research Fund Northwestern Memorial Hospital Children's Memorial Research Foundation |
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Information provided by: | Children's Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00532324 |
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.
Condition | Intervention |
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Staphylococcus Aureus |
Other: CA-MRSA Decolonization |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Single Group Assignment |
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 |
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 |
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A: No Intervention
Pregnant women not receiving CA-MRSA decolonization therapy.
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B
Pregnant women receiving CA-MRSA decolonization therapy.
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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.
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Age limits for infants will be 0-4 weeks of age and both genders will be included.
Contact: Tina Q Tan, M.D. | 773-880-4187 | titan@childrensmemorial.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 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. |
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 |
Responsible Party: | Children's Memorial Hospital/McGaw Medical Center of Northwestern University ( Tina Tan, MD/Associate Professor of Pediatrics ) |
Study ID Numbers: | 2007-13145(CMH)/2623-001(NU) |
Study First Received: | September 19, 2007 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00532324 History of Changes |
Health Authority: | United States: Institutional Review Board |
Methicillin resistant Staphylococcus aureus Staphylococcus aureus Healthy term and near term neonates |
Prevention Nasal and Vaginal Colonization rates Pregnant women |
Bacterial Infections Chlorhexidine Mupirocin Healthy Anti-Bacterial Agents Staphylococcal Infections Anti-Infective Agents, Local Disinfectants |
Gram-Positive Bacterial Infections Methicillin Chlorhexidine gluconate Sodium Hypochlorite Hexachlorophene Eusol Triclosan |
Bacterial Infections Anti-Bacterial Agents Anti-Infective Agents Anti-Infective Agents, Local Staphylococcal Infections Disinfectants |
Gram-Positive Bacterial Infections Methicillin Chlorhexidine Therapeutic Uses Pharmacologic Actions |