Evaluation of Culture Negative Severe Acute Respiratory Infection in Mexico
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Presence of etiologic agents among patients with SARI and whose culture, and multiplex PCR prove to be negative. This outcome will be described as a list of etiologic agents identified as well as the percentage of the sample affected.
研究概览
简要总结
The purpose of this study is to determine the feasibility of identifying novel etiologic agents associated with SARI in patients who have required intubation and in whom, after analysis, a causative agent was not identified by standard microbiologic (culture) and multiplex real-time Polymerase Chain Reaction (PCR) platforms. Taking into account that isolation of any pathogens is generally time sensitive, the study will evaluate subjects that are culture negative at the time of consent. Not all subjects will actually prove to be culture negative. Additionally, the study will compare etiologic agents identified on broncho-alveolar lavage (BAL) to etiologic agents identified by routine upper airway testing on all subjects with SARI.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Willing to provide informed consent; or a legal representative is willing to sign informed consent;
- •Intubated due to an independent clinical decision by a clinician responsible for the patient's clinical care and NOT affiliated with the research);
- •Meet WHO's SARI definition (modified) - all of the criteria below:
- •History of fever, subjective feverishness or measured fever of ≥ 38.0 °C, or hypothermia as defined for Systemic Inflammatory Response Syndrome (SIRS) (<36.0 °C );
- •Cough or other respiratory symptoms, such as rapidly progressing dyspnea;
- •Onset within the last 21 days (as long as the clinical condition is considered acute and due to the severity it requires intubation); and
- •Requiring hospitalization
排除标准
- •Intubated for reasons other than SARI (cardiovascular accident, surgery);
- •Known microbiologic diagnosis of SARI or respiratory illness:
- •Any contraindication to BAL by bronchoscopy as determined by the treating physician
- •Bacterial culture or other microbiologic testing for underlying etiology positive would be excluded;
- •In women: Pregnancy
结局指标
主要结局
Presence of etiologic agents among patients with SARI and whose culture, and multiplex PCR prove to be negative. This outcome will be described as a list of etiologic agents identified as well as the percentage of the sample affected.
时间窗: Baseline
次要结局
- Results of NP microRNA as compared to results from samples taken from the lower respiratory tract through BAL.(Baseline)
- Inflammatory profile of BAL samples, that will include measure of cytokine, chemokine, and growth factor levels.(Baseline)
- Results of NP multiplex real-time PCR as compared to results from samples taken from the lower respiratory tract through BAL.(Baseline)