A Prospective Cohort Pilot Study of the Clinical and Molecular Epidemiology of Staphylococcus Aureus in Pregnant Women at the Time of Group B Streptococcal Screening in a Large Urban Medical Center in Chicago, IL USA

NCT00532324 | Completed

• 1 other identifier: 2007-13145(CMH)/2623-001(NU)
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Pregnant women colonized with CA-MRSA are at higher risk for post-partum infection with this organism.
3. 3.To determine the incidence of nasal and vaginal colonization with CA-MRSA in pregnant women and determine the genetic similarities of these strains.
4. 4.To study CA-MRSA transmission dynamics and evaluate the incidence of SSTI and invasive infections in newborns born to S. aureus colonized mothers.
5. 5.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.

Conditions

Staphylococcus Aureus

Keywords

Methicillin resistant Staphylococcus aureus; Staphylococcus aureus; Healthy term and near term neonates; Prevention; Nasal and Vaginal Colonization rates; Pregnant women

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

A

NO INTERVENTION

Pregnant women not receiving CA-MRSA decolonization therapy.

B

OTHER

Pregnant women receiving CA-MRSA decolonization therapy.

Other: CA-MRSA Decolonization

Interventions

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.

Also known as: Mupirocin also known as Bactroban, Chlorhexidine also known as Phisohex, Clorox

B

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Thrasher Research Fund: collaborator
• Northwestern Memorial Hospital: collaborator

Study Sites (1)

Prentice Women's Hospital and Maternity Center of Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

• 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.

  PMID: 16514341 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.

  PMID: 15876949 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.

  PMID: 15712079 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.

  PMID: 16950976 BACKGROUND

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Mupirocin; Triclosan; Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Phenyl Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Division of Infectious Diseases

Study Record Dates

• First Submitted: September 19, 2007
• First Posted: September 20, 2007
• Study Start: February 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: October 1, 2013
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

US (1)