RECRUITING

An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED.

Conditions

Respiratory Tract Infections bacterial infection viral infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

Does an Adjunct Diagnostic Test That Can Discriminate Bacterial From Viral Etiology Early in the Management of Respiratory Infections Improve Management Accuracy and Quality in the Acute Care Setting?

Quick Facts

Study Start:2023-12-11

Study Completion:2024-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06070688

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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) * Blood tests are being ordered	* 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 is not in complete remission. * 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

Exclusion Criteria

* 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)
* Blood tests are being ordered

* 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 is not in complete remission.
* 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

Contacts and Locations

Study Contact

David Robinson, MD,MS,MMM

CONTACT

(713) 500-7873

David.J.Robinson@uth.tmc.edu

Neomi Sepulveda

CONTACT

713.500.8474

Neomi.Sepulveda@uth.tmc.edu

Principal Investigator

David Robinson, MD,MS,MMM

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

David Robinson, MD,MS,MMM, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-11

Study Completion Date2024-12-30

Study Record Updates

Study Start Date2023-12-11

Study Completion Date2024-12-30

Terms related to this study

Keywords Provided by Researchers

bacterial infection
viral infection

Additional Relevant MeSH Terms

Respiratory Tract Infections