Risk Factors for Early Infant Colonization With Methicillin-Resistant Staphylococcus Aureus

Methicillin-resistant Staphylococcus Aureus Clinical Trial

Official title:

Risk Factors for Early Infant Colonization With Methicillin-Resistant Staphylococcus Aureus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141101
• Other study ID #: H-29160
• Status: Completed
• Phase: N/A
• First received: June 9, 2010
• Last updated: May 1, 2016
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: May 2016
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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:

1. Identify the proportion, rate and time of MRSA colonization in infants born to mothers with and without MRSA colonization;

2. Compare risk factors for infant MRSA colonization in these two groups;

3. Determine the prevalence and risk factors for developing MRSA infections in the MRSA-colonized infant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Methicillin-resistant Staphylococcus Aureus
• Staphylococcal Infections

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	We will compare infants' MRSA-positivity rates in the exposed versus the unexposed study groups.		18 months	No
Secondary	We will determine if infant MRSA positivity appears earlier in exposed infants versus unexposed infants.		18 months	No
Secondary	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.		18 months	No