Methicillin-resistant Staphylococcus AureusNCT01141101
Risk Factors for Early Infant Colonization With Methicillin-Resistant Staphylococcus Aureus
An observational study of Methicillin-resistant Staphylococcus Aureus, run by Boston Medical Center at 1 site in United States.
Trial summary
The prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) colonization and infections have been increasing in the general population, including the pediatric population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Methicillin-resistant Staphylococcus Aureus
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jun 2012
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The exposed group will include 100 MRSA-colonized mothers and their babies. The unexposed group will include 100 MRSA-negative mothers and their babies. The groups will be conveniently selected from all mothers and infants meeting the inclusion and exclusion criteria each month. Enrollment will continue until 100 babies and mothers in the MRSA-positive mother group and 100 babies and mothers in MRSA-negative mother group are enrolled. We estimate that enrollment will require approximately 18 months to complete. Household contacts of infants will be enrolled. A contact is defined as any individual who had or has had the same primary residences (who has lived in the same house for at least one week) as the infant since the infant's birth. We will ask the infants mother to identify the infants household contacts. Infant care givers include any person who provides daily care to infant for at least 4 hours per day at least 3 days of week.
Who may be able to join
- Infants born at > 32 weeks of gestation.
- Mother must have been tested for MRSA prior to birth.
- Mother must be willing to provide informed consent for herself and infant.
- Mothers feel household contacts and caregivers will be willing to enroll in the study.
- Household contacts must be willing to provide informed consent (if greater than 18 years of age) or parent of household contact must be willing to provide informed consent for minors and the minor must provide assent (if greater than age 7) to enroll in study.
- Infant care givers must be willing to provide informed consent (if greater than 18 years of age) or parent of infant care giver must be willing to provide informed consent for minors and the minor must provide assent (if greater than age 7) to enroll in study.
Who cannot join
- Infants born at < 32 weeks gestation.
- Infants who will not be receiving their primary care at Boston Medical Center.
- Household contact or Infant Care giver not willing to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) colonization and infections have been increasing in the general population, including the pediatric population. It has been reported that MRSA colonization persists for up to four years, and therefore the youngest pediatric patients, specifically those who are less than 2 years of age, have a high risk of prolonged colonization during a period of time when they are susceptible to significant skin and soft tissue infections (SSTIs) attributable to MRSA. Once prolonged colonization takes place, recurrent SSTIs are commonplace, resulting in substantial morbidity and in some cases mortality, as well as a significant cost to the healthcare system. Individuals colonized with MRSA have an increased risk of developing MRSA infections, which range from mild disease, such as carbuncles, to severe infections, such as necrotizing pneumonia and toxic shock syndrome. The prevalence of severe MRSA infections is also greatest in neonates and infants, where increased MRSA colonization has been observed. In the early infant period, the most common manifestation of MRSA disease is pustular skin lesions, which affect approximately 5% of the general population, with MRSA-colonization being a major risk factor for this disease. Moreover, the prevalence of pustular disease is increasing in the general population, and there are numerous case reports of invasive, life-threatening MRSA disease in the early infant period.
Corresponding to the increasing prevalence in the community, the carriage of MRSA in pregnant women has also escalated, and vaginal carriage is significant in pregnant women. As an analogy, maternal vaginal Group B Streptococcal (GBS) colonization is the major risk for infant colonization regardless of whether early or late neonatal colonization or disease occurs. It is quite feasible that vaginal MRSA carriage predisposes newborns to colonization during the birthing process; however, this mechanism has not yet been well studied. There are other mechanisms implicated for early infant colonization, including close contact with MRSA-colonized mothers through daily care and breastfeeding. MRSA colonization in one household member greatly predisposes colonization in others; therefore, early infant colonization could result from contact with other MRSA-colonized individuals in a household. Currently, it is not clear which factors are the most important in influencing early infant MRSA colonization and subsequent infection.
Read more
Not only is the prevalence of MRSA colonization and infection on the rise, but there have been few if any measures that have been established to prevent colonization and subsequent infection in adults and children. Eradication measures have shown limited long-term benefit. If vertical transmission of MRSA can be established as a critical event in the pathogenesis of disease, potentially effective strategies could be tested, and possibly the spread of MRSA in the community interrupted.
Hypotheses and Specific Aims:
- Identify the proportion, rate and time of MRSA colonization in infants born to mothers with and without MRSA colonization;
- Compare risk factors for infant MRSA colonization in these two groups;
- Determine the prevalence and risk factors for developing MRSA infections in the MRSA-colonized infant.
- Keywords
- Methicillin-resistant Staphylococcus aureus, Neonatal, Vertical transmission, Horizontal transmission, MRSA colonization in enrolled infants, MRSA colonization obtained from maternal source, MRSA colonization obtained from source other that mother
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MRSA-exposed | The MRSA-exposed group will include 100 MRSA-colonized mothers and their babies | |
| MRSA-unexposed | The MRSA-unexposed group will include 100 MRSA-negative mothers and their babies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will compare infants' MRSA-positivity rates in the exposed versus the unexposed study groups.
Measured: 18 months
Secondary outcomes (2)
We will determine if infant MRSA positivity appears earlier in exposed infants versus unexposed infants.
Measured: 18 months
For infants who become MRSA-positive we will determine if their strain of MRSA is the same as their mothers' or other household contacts or care giver who is determined to be MRSA-positive.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methicillin-resistant Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Pelton, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141101
- Sponsor's protocol ID
- H-29160
- Status last verified
- May 2016
- First submitted
- 9 Jun 2010
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Early Infant Colonization With Methicillin-Resistant Staphylococcus Aureus
- ClinicalTrials.gov ID
- NCT01141101
- Acronym / sponsor ID
- H-29160
- Keywords
- Methicillin-resistant Staphylococcus aureus, Neonatal, Vertical transmission, Horizontal transmission, MRSA colonization in enrolled infants, MRSA colonization obtained from maternal source, MRSA colonization obtained from source other that mother
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Jun 2010 (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.
The prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) colonization and infections have been increasing in the general population, including the pediatric population. It has been reported that MRSA colonization persists for up to four years, and therefore the youngest pediatric patients, specifically those who are less than 2 years of age, have a high risk of prolonged colonization during a period of time when they are susceptible to significant skin and soft tissue infections (SSTIs) attributable to MRSA. Once prolonged colonization takes place, recurrent SSTIs are commonplace, resulting in substantial morbidity and in some cases mortality, as well as a significant cost to the healthcare system. Individuals colonized with MRSA have an increased risk of developing MRSA infections, which range from mild disease, such as carbuncles, to severe infections, such as necrotizing pneumonia and toxic shock syndrome. The prevalence of severe MRSA infections is also greatest in neonates and infants, where increased MRSA colonization has been observed. In the early infant period, the most common manifestation of MRSA disease is pustular skin lesions, which affect approximately 5% of the general population, with MRSA-colonization being a major risk factor for this disease. Moreover, the prevalence of pustular disease is increasing in the general population, and there are numerous case reports of invasive, life-threatening MRSA disease in the early infant period.
Corresponding to the increasing prevalence in the community, the carriage of MRSA in pregnant women has also escalated, and vaginal carriage is significant in pregnant women. As an analogy, maternal vaginal Group B Streptococcal (GBS) colonization is the major risk for infant colonization regardless of whether early or late neonatal colonization or disease occurs. It is quite feasible that vaginal MRSA carriage predisposes newborns to colonization during the birthing process; however, this mechanism has not yet been well studied. There are other mechanisms implicated for early infant colonization, including close contact with MRSA-colonized mothers through daily care and breastfeeding. MRSA colonization in one household member greatly predisposes colonization in others; therefore, early infant colonization could result from contact with other MRSA-colonized individuals in a household. Currently, it is not clear which factors are the most important in influencing early infant MRSA colonization and subsequent infection.
Not only is the prevalence of MRSA colonization and infection on the rise, but there have been few if any measures that have been established to prevent colonization and subsequent infection in adults and children. Eradication measures have shown limited long-term benefit. If vertical transmission of MRSA can be established as a critical event in the pathogenesis of disease, potentially effective strategies could be tested, and possibly the spread of MRSA in the community interrupted.
Hypotheses and Specific Aims:
- Identify the proportion, rate and time of MRSA colonization in infants born to mothers with and without MRSA colonization;
- Compare risk factors for infant MRSA colonization in these two groups;
- Determine the prevalence and risk factors for developing MRSA infections in the MRSA-colonized infant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRSA-exposed | – | –The MRSA-exposed group will include 100 MRSA-colonized mothers and their babies |
| MRSA-unexposed | – | –The MRSA-unexposed group will include 100 MRSA-negative mothers and their babies. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The exposed group will include 100 MRSA-colonized mothers and their babies. The unexposed group will include 100 MRSA-negative mothers and their babies. The groups will be conveniently selected from all mothers and infants meeting the inclusion and exclusion criteria each month. Enrollment will continue until 100 babies and mothers in the MRSA-positive mother group and 100 babies and mothers in MRSA-negative mother group are enrolled. We estimate that enrollment will require approximately 18 months to complete. Household contacts of infants will be enrolled. A contact is defined as any individual who had or has had the same primary residences (who has lived in the same house for at least one week) as the infant since the infant's birth. We will ask the infants mother to identify the infants household contacts. Infant care givers include any person who provides daily care to infant for at least 4 hours per day at least 3 days of week.
Key inclusion criteria (6 listed)
- Infants born at > 32 weeks of gestation.
- Mother must have been tested for MRSA prior to birth.
- Mother must be willing to provide informed consent for herself and infant.
- Mothers feel household contacts and caregivers will be willing to enroll in the study.
- Household contacts must be willing to provide informed consent (if greater than 18 years of age) or parent of household contact must be willing to provide informed consent for minors and the minor must provide assent (if greater than age 7) to enroll in study.
Key exclusion criteria (3 listed)
- Infants born at < 32 weeks gestation.
- Infants who will not be receiving their primary care at Boston Medical Center.
- Household contact or Infant Care giver not willing to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
We will compare infants' MRSA-positivity rates in the exposed versus the unexposed study groups.
Time frame: 18 months
2 secondary outcomes
We will determine if infant MRSA positivity appears earlier in exposed infants versus unexposed infants.
Time frame: 18 months
For infants who become MRSA-positive we will determine if their strain of MRSA is the same as their mothers' or other household contacts or care giver who is determined to be MRSA-positive.
Time frame: 18 months
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 3 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Methicillin-resistant Staphylococcus Aureus, run by Boston Medical Center 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 6 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 3 May 2016. 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?
We will compare infants' MRSA-positivity rates in the exposed versus the unexposed study groups. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2016.