HostDx Sepsis in Patients With Acute Respiratory Infections

BH19-063
Pulmonary/ Critical Care
Jay Steingrub, MD
Baystate Medical Center, 759 Chestnut St, Springfield, MA
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.

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population: Patients presenting to the ED with acute respiratory infections

Inclusion Criteria:

1. Age > 18 years
2. Suspected Acute upper or lower respiratory infection
3. At least two of the following:
a. Heart rate >90 beats / minute
b. Temperature >38 C or <36 C
c. Respiratory rate >20 breaths / minute
d. Systolic blood pressure <100 mmHg
e. 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.

Active
Observational [Patient Registry]
Sherell Thornton-Thompson
413-794-9056