Evaluation of Culture Negative Severe Acute Respiratory Infection in Mexico (CNSARI)

Mexican Emerging Infectious Diseases Clinical Research Network

Status: Terminated

Conditions: Severe Acute Respiratory Infection (SARI)

Study type: Observational

Funder types: Other; NETWORK; NIH

Identifiers

NCT03168282

CNSARI

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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