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New treatment option for Respiratory Tract Infections
Official title An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED.
ClinicalTrials.gov ID: NCT06070688
What this study is testing
- What it's testing
- The purpose of this study is to evaluate overall changes in patient management and longer-term resource utilization between control and test arms, including (but not limited to) additional work-up (including other diagnostic tests and consults), antimicrobial treatments, disposition decisions and hospital length of stay (LOS)
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for main study population :
- Current disease duration ≤ 7 days
- Temperature ≥ 37.8°C (100°F) or tactile fever, noted at least once within the last 7 days
- Clinical suspicion of bacterial or viral respiratory tract infection (RTI)
You likely can't join if
- for main study population:
- Systemic antibiotics taken up to 48 hours prior to presentation
- Outpatient steroids taken within 48 hours prior to presentation
- Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis
- Inflammatory disease
- Congenital immune deficiency (CID)
See the full eligibility criteria
- for main study population :
- Current disease duration ≤ 7 days
- Temperature ≥ 37.8°C (100°F) or tactile fever, noted at least once within the last 7 days
- Clinical suspicion of bacterial or viral respiratory tract infection (RTI)
- for main study population:
- Systemic antibiotics taken up to 48 hours prior to presentation
- Outpatient steroids taken within 48 hours prior to presentation
- Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis
- Inflammatory disease
- Congenital immune deficiency (CID)
- A proven or suspected infection on the presentation with Mycobacterial, parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen
- Human immunodeficiency virus(HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (self-declared or known from medical records)
- Major trauma and/or burns in the last 7 days
- Major surgery in the last 7 days
- Pregnancy - Self reported or medically confirmed
- Active malignancy - Cancer diagnosed within the previous six months, recurrent, regionally advanced, or metastatic cancer, cancer for which treatment had been administered within six months, or hematological cancer that...
- Current treatment with immune-suppressive or immune-modulating therapies, at some point in the past 10 days
- Hemodynamically unstable (require life-saving interventions such as vasopressors)
- Patients transferred from another facility who already have a differentiated respiratory illness (known diagnosis e.g., culture positive results)
- Consider unsuitable for the study by the study team Inclusion Criteria for Subgroup:
- Written informed consent must be obtained from the patient or his/her legal guardian
- Current disease duration ≤ 7 days
- Clinical suspicion of bacterial or viral sepsis based on 2 or more SIRS criteria OR Clinical suspicion of bacterial or viral respiratory tract infection (RTI) AND temperature ≥ 37.8°C (100°F) or tactile fever, noted at...
- Systemic antibiotics taken up to 48 hours prior to presentation
- Outpatient steroids taken within 48 hours prior to presentation
- Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis
- Inflammatory disease (e.g., IBD, SLE, RA, other vasculitis)
- Congenital immune deficiency (CID)
- A proven or suspected infection on the presentation with Mycobacterial (e.g., MAC, MABC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen
- HIV, HBV, or HCV infection (self-declared or known from medical records)
- Major trauma and/or burns in the last 7 days
- Major surgery in the last 7 days
- Pregnancy - Self reported or medically confirmed
- Active malignancy of a solid tumor - Cancer diagnosed within the previous six months, recurrent, regionally advanced, or metastatic cancer, cancer for which treatment had been administered within six months, or...
- Current treatment with immune-suppressive or immune-modulating therapies, at some point in the past 10 days
- Hemodynamically unstable (require life-saving interventions such as vasopressors)
- Patients transferred from another facility who already have a differentiated respiratory illness (known diagnosis e.g., culture positive results)
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.