Evaluation of Culture Negative Severe Acute Respiratory Infection in Mexico

NCT ID: NCT03168282

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-06
• Study Completion Date: 2018-04-11

Brief Summary

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.

Conditions

Severe Acute Respiratory Infection (SARI)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Secretaria de Salud, Mexico

OTHER_GOV

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Mexican Emerging Infectious Diseases Clinical Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arturo Galindo-Fraga

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Santiago Pérez Patrigeon

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Locations

Hospital Central de San Luis Potosí "Dr. Ignacio Morones Prieto" (SLP).

Mexico City, , Mexico

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)

Mexico City, , Mexico

Instituto Nacional de Enfermedades Respiratorias (INER)

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

CNSARI

Identifier Type: -

Identifier Source: org_study_id