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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 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.
时间窗: Infants born to CA-MRSA colonized mothers will be followed for CA-MRSA colonization and/or SSTIs for the first 4 weeks of life.
次要结局
- 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.)
研究者
Tina Q. Tan
Attending Physician, Division of Infectious Diseases
Ann & Robert H Lurie Children's Hospital of Chicago