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

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.

Study Overview

• Status: Terminated
• Conditions: Severe Acute Respiratory Infection (SARI)

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Mexico
  • Ciudad de Mexico, Mexico
    • Hospital Central de San Luis Potosí "Dr. Ignacio Morones Prieto" (SLP).
  • Ciudad de Mexico, Mexico
    • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)
  • Ciudad de Mexico, Mexico
    • Instituto Nacional de Enfermedades Respiratorias (INER)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be selected from hospitalized patients who seek medical care due to SARI at the participating sites of LaRed Network, and who meet inclusion criteria and do not meet any exclusion criteria. For those who accept participation, either personally or through a Legally Authorized Representative (per all applicable legal and regulatory requirements complying with the sites regulations) the study will be explained and informed consent will be obtained. The study population will not include children. Pregnant women are not eligible.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mexican Emerging Infectious Diseases Clinical Research Network
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Secretaria de Salud, Mexico
• Investigators: Principal Investigator: Arturo Galindo-Fraga, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; Principal Investigator: Santiago Pérez Patrigeon, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2017
• Primary Completion (Actual): April 11, 2018
• Study Completion (Actual): April 11, 2018

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: CNSARI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD will be shared at the end of the study, by establishing collaborations with LaRed. Initial contact would occur through the principle investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No