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临床试验/NCT02981550
NCT02981550撤回不适用

Infection Detection by Breath Analysis

BreathTec Biomedical Inc.0 个研究点开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Evidence of Infection detected by exhaled breath analysis confirmed by laboratory culture

研究概览

简要总结

The purpose of this feasibility study is to test a device which analyzes breath and may allow doctors and health professionals to immediately determine if an ill patient has a specific type of bacterial infection. This will allow a health professional to provide immediate targeted antibiotics to properly start treatment without delay.

详细描述

Community acquired, or hospital acquired [nosocomial] infections [pathogens] are a common cause for morbidity and mortality. Initiation of antibiotic treatment is by best guess or using a broad spectrum antibiotic. The improper administration of antibiotics is known to lead to the developing specter of antibiotic resistant organisms.

Certain community acquired bacterial infection such as Streptococcus upper respiratory tract infections carry increased risk of morbidity secondary to risk of developing abscess, glomerulonephritis, and/or rheumatic fever. Commonly, most upper respiratory tract infections are caused by viruses. However due to the unknown pathogen causing an upper respiratory tract infection, with the risks of potential chronic severe complications from Streptococcus, initial treatment starts with either an antibiotic, or a typical 3day wait for bacterial culture result. Quite often, the wait-and-see approach in the community is not undertaken because of the difficulty in returning for a follow-up appointment.

The risk of a developing antibiotic resistant bacteria is well-known and is one of the greatest health threats worldwide leading to longer hospitalizations, higher medical costs and death, according to the World Health Organization. Thus a point of care device which would enable physicians or other medical practitioners to promptly discriminate between Streptococcal or other antibiotic sensitive pathogens versus non antibiotic sensitive viral causes of specific upper respiratory tract infectious pathogens is needed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able and willing to participate in this study
  • Availability of signed informed consent
  • Healthy, not on any medication
  • Able to provide a breath sample
  • Having a condition (eg. suspected strep throat, MRSA, C difficile) which would require a swab/sample for culture

排除标准

  • Under the age of 6years
  • Eating food or drink (excluding water) within 2 hours of breath test time
  • Pregnant or Breastfeeding
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Inability to comply with study procedure/unable to follow directions
  • Currently taking antibiotics or other medication (excluding analgesics)

结局指标

主要结局

Evidence of Infection detected by exhaled breath analysis confirmed by laboratory culture

时间窗: Within 3 to 7 days of obtaining culture and exhaled breath sample

次要结局

未报告次要终点

研究者

发起方
BreathTec Biomedical Inc.
申办方类型
Industry
责任方
Sponsor

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