Community-Acquired Methicillin Resistant Staphylococcus Aureus Colonization in Pregnant Women and Infections in Newborns
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators:
Thrasher Research Fund
Northwestern Memorial Hospital
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00532324
First received: September 19, 2007
Last updated: March 10, 2011
Last verified: April 2009
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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 Ann & Robert H Lurie Children's Hospital of Chicago:
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:
|
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
Ann & Robert H Lurie Children's Hospital of Chicago
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:
| 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 Ann & Robert H Lurie Children's Hospital of Chicago:
|
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 16, 2013