Evaluation of Culture Negative Severe Acute Respiratory Infection in Mexico

Severe Acute Respiratory Infection (SARI) Clinical Trial

— CNSARI  

Official title:

Evaluation of Culture Negative Severe Acute Respiratory Infection in Mexico

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03168282
• Other study ID #: CNSARI
• Status: Terminated
• Start date: April 6, 2017
• Est. completion date: April 11, 2018

Study information

• Verified date: November 2018
• Source: Mexican Emerging Infectious Diseases Clinical Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: April 11, 2018
• Est. primary completion date: April 11, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Tract Infections
• Severe Acute Respiratory Infection (SARI)

Locations

Country	Name	City	State
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)	Ciudad de Mexico

Sponsors (3)

Lead Sponsor	Collaborator
Mexican Emerging Infectious Diseases Clinical Research Network	National Institute of Allergy and Infectious Diseases (NIAID), Secretaria de Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Inflammatory profile of BAL samples, that will include measure of cytokine, chemokine, and growth factor levels.		Baseline