Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

This study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, intra-abdominal, and/or skin & soft tissue infections; or suspected sepsis of any cause.

Official Title

HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis

Keywords

Respiratory Tract Infections Urinary Tract Infections Intra-Abdominal Infections Skin and Soft Tissue Infection Sepsis Infection mRNA Procalcitonin C-Reactive Protein Lactate Communicable Diseases Toxemia Intraabdominal Infections Soft Tissue Infections Emergencies HostDx Sepsis

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age >18 year
  2. 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:
  3. Heart rate: >90 beats/ minute
  4. Temperature: >38 C or <36C
  5. Respiratory Rate: >20 breaths / minutes or PaO2 of <60 mmHg or SpO2 <90%
  6. Systolic blood pressure: <100 mmHg
  7. Altered mental status: Per clinical exam
  8. Able to provide informed consent, or consent by legally authorized representative.

You CAN'T join if...

  1. Patient-reported treatment with systemic antibiotics, systemic antiviral agents, or systemic antifungal agents within the past 7 days prior to the emergency department study visit. Participants will not be excluded for the following:
  2. Use of topical antibiotics, topical antiviral or topical antifungal agents
  3. Use of peri-operative (prophylactic) antibiotics
  4. Use of a single dose of antibiotics during the present ED visit (<6h before blood draw).
  5. Prisoners, mentally disabled, or unable to give consent. Should the patient not be able to provide informed consent the legally authorized representative can provide the consent on behalf of the patient.
  6. Previously enrolled in the present clinical trial.

Locations

  • University of California Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Texas Tech University Health Sciences Center - El Paso accepting new patients
    El Paso Texas 79905 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Inflammatix
Links
Sign up for this study
ID
NCT04094818
Study Type
Observational
Last Updated