HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections: a Multicenter Pilot Study
Completed
Conditions studied: Respiratory Tract Infections, Urinary Tract Infections, Skin and Soft Tissue Infections, Intraabdominal Infections, Sepsis
In brief
This study will analyze gene expression data (HostDx Sepsis test) from blood samples collected from participants with suspected 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 infection and 1 vital signs OR suspected sepsis and 2 vital sign changes as stated in the protocol are meeting enrollment criteria
Key facts
- Study ID
- NCT03744741
- Run by
- Inflammatix
- People needed
- 585
- Starts
- 2018-07-23
- Expected to finish
- 2020-01-20
- Last updated by the study team
- 2021-12-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18 year
- Suspected Suspected acute infection (respiratory, urinary, abdominal, skin \& soft-tissue), and at least one of the symptoms OR, Suspected sepsis of any cause as defined by a blood culture order by the treating physician, and at least two of the symptoms:
- Heart rate: >90 beats/ minute
- Temperature: >38 C or <36C
- Respiratory Rate: >20 breaths / minutes or PaO2 of <60 mmHg or SpO2 <90%
- Systolic blood pressure: <100 mmHg
- Altered mental status: Per clinical exam
- Able to provide informed consent, or consent by legally authorized representative.
- Subjects in the healthy control group will be eligible if they are i) >18 years of age, ii) able to provide informed consent, iii) in their normal state of health, and iv) do not meet inclusion criteria above
You may not qualify if…
- Treatment with systemic antibiotics, antiviral agents, or antifungal agents within the past 7 days prior to the emergency department study visit. Participants will not be excluded for the use topical antibiotics, antiviral agents, or antifungal agents.
- Prisoners, mentally disabled, or unable or unwilling to give consent.
- Previously enrolled in the present clinical trial
Where it is running
- Emory University — Atlanta, Georgia, United States
- University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
- Baystate Medical Center — Springfield, Massachusetts, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- Texas Tech University Health Sciences Center El Paso — El Paso, Texas, United States
- Attikon University Hospital — Chaïdári, Greece
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.