HostDx Sepsis in Patients With Acute Respiratory Infections
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03744741|
Recruitment Status : Active, not recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
|Condition or disease||Intervention/treatment|
|Respiratory Tract Infections||Diagnostic Test: HostDx Sepsis|
Enrollment will be offered to patients who meet criteria (defined below) at presentation to the emergency department. All patients will undergo standard-of-care treatment. Fig. 1 provides an overview of the study design.
Blood sample collections: Clinical study staff or the treating physician will obtain patient consent and collect two PAXgene RNA tubes of whole blood by venipuncture. The blood samples will be stored at room temperature overnight prior to being frozen at -80C for long-term storage. Samples will be shipped to the sponsor for testing using the HostDX Sepsis test. An additional tube of blood obtained via venipuncture and stored for shipment to a centralized testing laboratory, where it will be tested for C-reactive protein (CRP) and procalcitonin (PCT). This will be done for all participants, even if they had these tests ordered locally as standard of care (SOC).
Microbiology sample collections: For diagnosed/unhealthy participants (regardless whether they had or had not provided a nasopharyngeal swab for a respiratory panel), a nasopharyngeal swab for a respiratory pathogen panel will be obtained and sent to a central laboratory for testing.
For participants with a productive cough and if sputum culture is SOC at the clinical site, a sputum culture will be ordered and run in the local microbiology lab, Participants will receive the institution's standard of care treatment for respiratory infection.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||150 participants|
|Target Follow-Up Duration:||1 Month|
|Official Title:||HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Acute Respiratory Infections: a Multicenter Pilot Study|
|Actual Study Start Date :||July 23, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
- Diagnostic Test: HostDx Sepsis
Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collectionOther Names:
- C-reactive protein
- Molecular respiratory pathogen panel
- Concordance of HostDx Sepsis diagnostic test read-out: likelihood of bacterial infection [ Time Frame: 30 days after enrollment ]Percent agreement of HostDx Sepsis bacterial readout with clinical adjudication by physician 30 days after enrollment for the presence of a bacterial infection
- Concordance of HostDx Sepsis diagnostic test read-out: likelihood of viral infection [ Time Frame: 30 days after enrollment ]Percent agreement of HostDx Sepsis viral readout with clinical adjudication by physician 30 days after enrollment for the presence of a viral infection
- Concordance of HostDx Sepsis prognostic read-out (severity) with patient outcome [ Time Frame: 30 days after enrollment ]Percent agreement between HostDx Sepsis severity readout and patient outcome, ie mortality, severity of infection, management of patient
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744741
|United States, California|
|Burlingame, California, United States, 94010|