Evaluation of Culture Negative Severe Acute Respiratory Infection in Mexico

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Culture Negative Severe Acute Respiratory Infection in Mexico

Conditions
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Severe Acute Respiratory Infection (SARI)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of NP multiplex real-time PCR as compared to results from samples taken from the lower respiratory tract through BAL. | The comparison will allow for determining difference between upper airway nasopharyngeal (NP) Multiplex real-time results and lower respiratory multiplex real-time PCR results. | Baseline | 
| Results of NP microRNA as compared to results from samples taken from the lower respiratory tract through BAL. | The comparison will allow for determining difference between upper airway nasopharyngeal (NP) microRNA results and lower respiratory microRNA results. | Baseline | 
| Inflammatory profile of BAL samples, that will include measure of cytokine, chemokine, and growth factor levels. |  | Baseline |