Clinical trial NCT03168282: Evaluation of Culture Negative Severe Acute Respiratory Infection in Mexico
Official title: Evaluation of Culture Negative Severe Acute Respiratory Infection in Mexico
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Severe Acute Respiratory Infection (SARI)
Lead sponsor: Mexican Emerging Infectious Diseases Clinical Research Network
Sponsor class: NETWORK
Collaborators: name: Secretaria de Salud, Mexico
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2017-05-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.


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

Primary outcomes:
measure: 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.
timeFrame: Baseline
Secondary outcomes:
measure: Results of NP multiplex real-time PCR as compared to results from samples taken from the lower respiratory tract through BAL.
timeFrame: Baseline
measure: Results of NP microRNA as compared to results from samples taken from the lower respiratory tract through BAL.
timeFrame: Baseline
measure: Inflammatory profile of BAL samples, that will include measure of cytokine, chemokine, and growth factor levels.
timeFrame: Baseline
Other outcomes:
Locations:
city: Ciudad de Mexico
country: Mexico
facility: Hospital Central de San Luis Potosí "Dr. Ignacio Morones Prieto" (SLP).
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias (INER)
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Arturo Galindo-Fraga
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Santiago Pérez Patrigeon
role: PRINCIPAL_INVESTIGATOR
References: