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| Name | Class |
|---|---|
| Secretaria de Salud, Mexico | OTHER_GOV |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Measure | Description | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Central de San Luis Potosà "Dr. Ignacio Morones Prieto" (SLP). | Mexico City | Mexico | ||||
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) |
IPD will be shared at the end of the study, by establishing collaborations with LaRed. Initial contact would occur through the principle investigators.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 11, 2019 | |
| Reset | May 2, 2019 | |
| Release | Jul 15, 2019 | |
| Reset | Aug 5, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 11, 2019 | May 2, 2019 | |||
| Jul 15, 2019 |
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Nasopharyngeal swab; Broncho-alveolar Lavage
| 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 |
| Mexico City |
| Mexico |
| Instituto Nacional de Enfermedades Respiratorias (INER) | Mexico City | Mexico |
| Aug 5, 2019 |