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

November 5, 2018 updated by: Mexican Emerging Infectious Diseases Clinical Research Network
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: Baseline
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.
Time Frame: Baseline
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.
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mexican Emerging Infectious Diseases Clinical Research Network

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)
Secretaria de Salud, Mexico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 11, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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