HostDx Sepsis in the Diagnosis and Prognosis Patients With Acute Respiratory Infections
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Infectious Disease, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/18/2018 |
| Start Date: | July 23, 2018 |
| End Date: | December 2019 |
HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Acute Respiratory Infections: a Multicenter Pilot Study
This study will analyze gene expression data (HostDx Sepsis test) from blood samples
collected from participants with suspected respiratory infections. The primary endpoint of
the study is to prospectively validate the HostDx Sepsis test for infections. As a secondary
endpoint the correlation of participant prognosis and gene expression results in the HostDx
Sepsis test will be validated. Participants presenting to the emergency departments of
enrolling sites with a suspected bacterial or viral respiratory infection and 2+ vital signs
are meeting enrollment criteria
collected from participants with suspected respiratory infections. The primary endpoint of
the study is to prospectively validate the HostDx Sepsis test for infections. As a secondary
endpoint the correlation of participant prognosis and gene expression results in the HostDx
Sepsis test will be validated. Participants presenting to the emergency departments of
enrolling sites with a suspected bacterial or viral respiratory infection and 2+ vital signs
are meeting enrollment criteria
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 and procalcitonin. 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.
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 and procalcitonin. 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.
Inclusion Criteria:
1. Age > 18 years
2. Suspected Acute upper or lower respiratory infection
3. At least two of the following:
1. Heart rate >90 beats / minute
2. Temperature >38 C or <36 C
3. Respiratory rate >20 breaths / minute
4. Systolic blood pressure <100 mmHg
5. Altered mental status
4. Able to provide informed consent
Exclusion Criteria:
1. Treatment with antibiotics, antiviral agents, or antifungal agents within the past 7
days.
2. Prisoners, mentally disabled, or unable or unwilling to give consent.
3. Previously enrolled in the present clinical trial
4. Concurrently enrolled in other clinical studies requiring blood draws totaling more
than 35 ml within 7 days of enrollment here.
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