Feasibility Study for Identifying a Sero-correlate of Protection Against Invasive Group B Streptococcus Disease in Newborns and Young Infants Aged Less ≤90 Days
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,033
- 试验地点
- 1
- 主要终点
- Proportion (Percentage) of maternal subjects enrolled in the study relative to the number of pregnant women screened.
研究概览
简要总结
The purpose of this study is to evaluate antibody levels against Group B streptococcus in mothers and the risk of developing invasive Group B streptococcus disease in newborns of less than 6 days age as well as infants of age less than 90 days age.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women (irrespective of gestational age staging or underlying comorbidities) attending for antenatal care at Chris Hani Baragwanath Academic Hospital (CHBAH) or an allied antenatal clinic and/or delivering at the participating delivery center (CHBAH)
- •Subjects aged ≥18 years.
- •Able to understand and comply with planned study procedures.
- •Provides written informed consent.
排除标准
- •Subjects Refusing to consent to study participation.
研究组 & 干预措施
Cases Group
Cases Group will be defined as:
Maternal subjects identified with invasive GBS disease from the enrolled maternal-newborn dyad Study cohort: Cases will be classified as follows:
- EOD (Early onset disease): isolation of GBS from the blood or cerebrospinal fluid (CSF) within 0-6 days of birth.
- LOD (Late onset disease): isolation of GBS from the blood or cerebrospinal fluid (CSF) within 7-90 days of birth.
干预措施: Blood sample (Procedure)
Cases Group
Cases Group will be defined as:
Maternal subjects identified with invasive GBS disease from the enrolled maternal-newborn dyad Study cohort: Cases will be classified as follows:
- EOD (Early onset disease): isolation of GBS from the blood or cerebrospinal fluid (CSF) within 0-6 days of birth.
- LOD (Late onset disease): isolation of GBS from the blood or cerebrospinal fluid (CSF) within 7-90 days of birth.
干预措施: Vaginal swab sample (Other)
Controls Group
Controls will be defined as newborns to mothers, enrolled into the study and identified as colonized by a serotype which is homologous to that of cases, but who do not develop invasive GBS disease.
干预措施: Blood sample (Procedure)
Controls Group
Controls will be defined as newborns to mothers, enrolled into the study and identified as colonized by a serotype which is homologous to that of cases, but who do not develop invasive GBS disease.
干预措施: Vaginal swab sample (Other)
结局指标
主要结局
Proportion (Percentage) of maternal subjects enrolled in the study relative to the number of pregnant women screened.
时间窗: During routine antenatal visits in the 4 months enrollment period (in antenatal clinics attached to study delivery units or the clinics serving the population delivering at those unit)
Maternal mothers were excluded at screening if: * Age \<18 yrs. * Not planning to deliver at study center. * Did not consent.
Proportion (percentage) of maternal subjects enrolled at delivery.
时间窗: At delivery
Percentage of maternal mothers who were not excluded at screening and who were enrolled at delivery visit.
Percentage of maternal subjects who had culture positive for GBS, classified by serotype.
时间窗: Throughout the study, an average of 4 months.
Proportion (percentage) of enrolled mother-infant dyads with cord blood collected.
时间窗: At delivery
Percentage of maternal mother (who were not excluded at screening) -infants dyads and with cord blood sample obtained for serology.
Percentage of maternal subjects, with vaginal swab samples, culture positive for GBS.
时间窗: Throughout the study, an average of 4 months.
GBS anti-capsular antibody concentration (serotype-specific anti capsular antibody) in maternal subjects, vaginally colonized with GBS.
时间窗: At delivery
GBS anti-capsular antibody concentration (serotype-specific anticapsular antibody) in infant subjects.
时间窗: At birth
Proportion (percentage) of maternal subjects enrolled in ante-natal clinics.
时间窗: During routine antenatal visits in the 4 months enrollment period(in antenatal clinics attached to study delivery units)
Percentage of maternal mothers who were not excluded at screening and who were presenting in antenatal clinics.
Proportion (percentage) of enrolled mother-infant dyads with both maternal and cord blood collected.
时间窗: At delivery
Percentage of maternal mother (who were not excluded at screening) -infants dyads and with both maternal and cord blood sample obtained for serology.
Proportion (percentage) of mother-infant dyads with complete data on the defined key clinical variables.
时间窗: Throughout the study, an average of 4 months.
Percentage of maternal mother (who were not excluded at screening) -infants dyads with defined key clinical variables. The key clinical variables have been defined as follows: Maternal subjects * Smoking during pregnancy, * Vaginal douche during pregnancy, * Gestational age at enrolment, * HIV test completed during routine care, * For those with test completed availability of test result and for HIV positive subjects CD4 count and viral load data. * Time between rupture of membranes and delivery, * Intrapartum antibiotic usage at delivery and duration of treatment * Evidence of intra-amniotic uterine infection. Infant subjects: * Birth weight, * Head circumference, * Congenital malformation, * Completion of 90-day follow-up visit in subset of sub-jects (cases and controls) eligible for this visit.
Percentage of subjects who completed the 90-day follow up visit in subset of subjects eligible for this visit.
时间窗: At 90 day follow up visit
Proportion (percentage) of mother-infant dyads enrolled with data available to assess early censorship criteria.
时间窗: At delivery
Percentage of mothers who were not excluded at screening and with data available to assess Early censoring criteria for defining the final analysis population: * Intravenous intrapartum antibiotics at delivery. * Blood transfusion in the 30 days prior to delivery. * Infant born with life threatening condition/ congenital malformation. * Failure to complete 90 day Follow-Up for potential controls. * Non-homologous serotype in case infants and mothers.
次要结局
未报告次要终点