Staphylococcus AureusNCT00532324
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
A study testing CA-MRSA Decolonization in people with Staphylococcus Aureus, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Staphylococcus Aureus
- What is being tested?
- CA-MRSA Decolonization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Prentice Women's Hospital and Maternity Center of Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
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.
Read more
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.
Read the detailed description
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:
- 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:
- To determine the incidence of nasal and vaginal colonization with CA-MRSA in pregnant women and determine the clonality of these strains.
- To study CA-MRSA transmission dynamics and evaluate the incidence of SSTI and invasive infections in term and near-term newborns born to S. aureus vaginal and/or nasal 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.
Methods:
- Vaginal and anterior nasal cultures will be obtained prospectively over several months from pregnant women who obtain their prenatal care through Obstetrical practices at Prentice Women's Hospital and Maternity Center of Northwestern Memorial Hospital during the time of GBS screening at 34-36 weeks gestation. Together, these practices account for 300-500 deliveries per month.
- Cultures will be plated on blood agar and incubated at 37oC for 48 hours. S. aureus strains will be identified by colony morphology and latex agglutination. MRSA isolates will be identified by PCR or latex agglutination for penicillin binding protein 2a by detecting the mecA gene and clonality by PFGE. PCR testing will then be used to identify strains carrying the Panton-Valentine Leukocidin gene as a marker of virulence.
- In a prospective case-control cohort study, newborns born to CA-MRSA colonized mothers will have anterior nares cultures for S. aureus obtained at birth and followed for the development of SSTI and invasive infections for one month. Samples positive for MRSA will be tested for similarities to maternal isolates through methods described above. The newborn incidence of MRSA infection will be compared between those born to non-colonized mothers and those born to colonized mothers.
- In further 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 with or without diluted chlorhexidine or Clorox baths or, 2) no intervention.
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.
- Conditions
- Staphylococcus Aureus
- Being tested
- CA-MRSA Decolonization
- Keywords
- Methicillin resistant Staphylococcus aureus, Staphylococcus aureus, Healthy term and near term neonates, Prevention, Nasal and Vaginal Colonization rates, Pregnant women
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CA-MRSA DecolonizationOther
Also called Mupirocin also known as Bactroban, Chlorhexidine also known as Phisohex, Clorox
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.
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Pregnant women not receiving CA-MRSA decolonization therapy. |
| B | Other | Pregnant women receiving CA-MRSA decolonization therapy. Receives: Other: CA-MRSA Decolonization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Infants born to CA-MRSA colonized moms will be followed for CA-MRSA colonization and/or SSTIs for the first 4 weeks of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startFeb 2008
- Primary completionJun 2009
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund, Northwestern Memorial Hospital
- Responsible party
- Principal investigator, Tina Q. Tan, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Tina Q Tan, M.D., Principal investigator, Children's Memorial Hospital/Northwestern University Feinberg School of MedicineLatania K Logan, M.D., Principal investigator, Children's Memorial Hospital/Northwestern University Feinberg School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532324
- Sponsor's protocol ID
- 2007-13145(CMH)/2623-001(NU)
- Status last verified
- Mar 2025
- First submitted
- 19 Sep 2007
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16514341Crawford 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.
PubMed 15876949Deresinski 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.
PubMed 15712079Fortunov 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.
PubMed 16950976
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00532324
- Acronym / sponsor ID
- 2007-13145(CMH)/2623-001(NU)
- Conditions
- Staphylococcus Aureus
- Keywords
- Methicillin resistant Staphylococcus aureus, Staphylococcus aureus, Healthy term and near term neonates, Prevention, Nasal and Vaginal Colonization rates, Pregnant women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Thrasher Research Fund, Northwestern Memorial Hospital
- Study start
- Feb 2008 (actual)
- Primary completion
- Jun 2009 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 20 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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:
- To determine the incidence of nasal and vaginal colonization with CA-MRSA in pregnant women and determine the clonality of these strains.
- To study CA-MRSA transmission dynamics and evaluate the incidence of SSTI and invasive infections in term and near-term newborns born to S. aureus vaginal and/or nasal 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.
Methods:
- Vaginal and anterior nasal cultures will be obtained prospectively over several months from pregnant women who obtain their prenatal care through Obstetrical practices at Prentice Women's Hospital and Maternity Center of Northwestern Memorial Hospital during the time of GBS screening at 34-36 weeks gestation. Together, these practices account for 300-500 deliveries per month.
- Cultures will be plated on blood agar and incubated at 37oC for 48 hours. S. aureus strains will be identified by colony morphology and latex agglutination. MRSA isolates will be identified by PCR or latex agglutination for penicillin binding protein 2a by detecting the mecA gene and clonality by PFGE. PCR testing will then be used to identify strains carrying the Panton-Valentine Leukocidin gene as a marker of virulence.
- In a prospective case-control cohort study, newborns born to CA-MRSA colonized mothers will have anterior nares cultures for S. aureus obtained at birth and followed for the development of SSTI and invasive infections for one month. Samples positive for MRSA will be tested for similarities to maternal isolates through methods described above. The newborn incidence of MRSA infection will be compared between those born to non-colonized mothers and those born to colonized mothers.
- In further 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 with or without diluted chlorhexidine or Clorox baths or, 2) no intervention.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –Pregnant women not receiving CA-MRSA decolonization therapy. |
| B | Other | Other: CA-MRSA DecolonizationPregnant women receiving CA-MRSA decolonization therapy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CA-MRSA DecolonizationAlso: Mupirocin also known as Bactroban, Chlorhexidine also known as Phisohex, CloroxIn 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 | B |
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Background: PubMed 16514341Kollef 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.
- Background: PubMed 15876949Crawford 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.
- Background: PubMed 15712079Deresinski 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.
- Background: PubMed 16950976Fortunov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina Q Tan, M.D. principal investigator
Children's Memorial Hospital/Northwestern University Feinberg School of Medicine
Latania K Logan, M.D. principal investigator
Children's Memorial Hospital/Northwestern University Feinberg School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CA-MRSA Decolonization in people with Staphylococcus Aureus, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00532324, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.