Evaluation of Culture Negative Severe Acute Respiratory Infection in Mexico

NCT03168282 | Terminated

• 1 other identifier: CNSARI
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 3

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Results of NP multiplex real-time PCR as compared to results from samples taken from the lower respiratory tract through BAL.

  Baseline

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mexican Emerging Infectious Diseases Clinical Research Network: lead
• Secretaria de Salud, Mexico: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (3)

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

Mexico City, Mexico

Location

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

Mexico City, Mexico

Location

Instituto Nacional de Enfermedades Respiratorias (INER)

Mexico City, Mexico

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal swab; Broncho-alveolar Lavage

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 30, 2017
• Study Start: April 6, 2017
• Primary Completion: April 11, 2018
• Study Completion: April 11, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

ME (3)