跳至主要内容
临床试验/NCT01445717
NCT01445717已完成不适用

Use of a New Rapid Method, BioNanoPore, for Growth and Detection of Group B Streptococcus in Pregnant Patients

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 358 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
358
试验地点
1
主要终点
Culture of Group B streptococcus

研究概览

简要总结

This study evaluates the use of a new method of growing and detecting Group B streptococcus in pregnant women. This new method utilizes sandwiched-membrane petri technology and has the advantage of detecting GBS in less than 6 hours, with less cost, and the potential of allowing antibiotic sensitivities to be performed.

详细描述

Intrapartum infection with group B streptococci (GBS) may lead to untoward neonatal sequelae such as pneumonia, septicemia, and meningitis. Several clinical trials have demonstrated that the use of intrapartum intravenous antibiotic prophylaxis (with penicillin being the agent of choice due to a narrower spectrum of antimicrobial activity) is highly effective to prevent early-onset neonatal GBS infections. It has been estimated that 10% to 30% of all pregnant women are GBS carriers, and it is likely that GBS colonizes virtually every female at some point. Consensus guidelines from the Centers for Disease Control and Prevention (CDC), American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Pediatrics, recommend prenatal screening at 35 to 37 weeks of gestation and chemoprophylaxis at delivery based upon this culture result. The CDC-recommended method for detecting GBS colonization involves collecting a combined vaginal and rectal specimen and culturing the organism in a selective broth medium, followed be subculturing onto blood agar plates.

However, this traditional method of culture takes up to 72 hours for results to be available. With 12.8% of patients experiencing a preterm delivery prior to when a GBS screening occurs, and up to 15% of term pregnancies not having routine GBS screening performed, a significant portion of women present with unknown GBS status at the time of potential delivery. These clinical situations require obstetricians to utilize a risk-based strategy that has been shown to be only half as effective as culture-based screening. Thus, a need exists for a rapid detection method for GBS.

Recent research has focused on polymerase chain reaction (PCR) based methods for detection of GBS. Sensitivity for detection of GBS by the PCR assay has ranged from 87% to 91%. These methods are limited by high cost, and inability to perform antibiotic sensitivities for GBS (in women with a penicillin allergy). New technologies, called bionanopore (BNP) and bionanofilter (BNF) are rapid, microbial detection systems that utilizes sandwiched-membrane petri technology. These have the advantage of detecting GBS in less than 6 hours, with less cost, and the potential of allowing antibiotic sensitivities to be performed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • > 18 years
  • 35-37 weeks pregnancy
  • Patient receiving prenatal care at UT Houston Hermann Memorial OB/Gyn resident or attending clinic.

排除标准

  • Pt elects not to participate

结局指标

主要结局

Culture of Group B streptococcus

时间窗: 48 hours

Rapid assay results will be compared to routine culture results.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan P Faro

Assistant Professor, ObGyn

The University of Texas Health Science Center, Houston

研究点 (1)

Loading locations...

相似试验