Respiratory Tract InfectionsNCT03744741
HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections: a Multicenter Pilot Study
An observational study of Respiratory Tract Infections and Urinary Tract Infections, run by Inflammatix at 7 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Infections, Urinary Tract Infections, Skin and Soft Tissue Infections
- What is being tested?
- HostDx Sepsis
- How many people
- 585 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 23 Jul 2018to 20 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the ED with acute infections or suspected sepsis
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Emory University
Atlanta, Georgia, 30322
Henry Ford Hospital
Detroit, Michigan, 48202
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, 79905
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 16148
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
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
Read the detailed description
Subjects presenting to the emergency department with a suspected acute infection will be eligible. Suspected infections may be of a) respiratory, b) urinary, c) intra-abdominal, or d) skin \& soft tissue etiology. Subjects with suspected sepsis of any cause will also be eligible.
Blood sample collections: Clinical study staff or the treating physician will obtain patient consent and collect two PAXgene RNA tubes of whole blood by venipuncture. The blood samples will be stored at room temperature overnight prior to being frozen at -80C for long-term storage. Samples will be shipped to the sponsor for testing using the HostDx Sepsis test. An additional tube of blood obtained via venipuncture and stored for shipment to a centralized testing laboratory, where it will be tested for C-reactive protein and procalcitonin. This will be done for all participants, even if they had these tests ordered locally as SOC.
In participants with suspected respiratory tract infections a nasopharyngeal swab will be collected as intervention and sent to the reference laboratory. The sample will be processed in a respiratory pathogen panel (regardless of whether the participants had or had not provided a nasopharyngeal swab for local testing with a respiratory panel as SOC).
Results obtained from microbiological testing of the following additional samples will be recorded if testing had been performed locally as SOC:
- Suspected urinary tract infection: Urine sample for culture.
- Suspected skin \& soft tissue infection: Swab from wound or abscess drainage, or other sample, for culture.
- Suspected intra-abdominal infection or abscesses (e.g. appendicitis, diverticulitis, cholecystitis): Swab, biopsy or other sample types for culture
- Suspected sepsis of any cause: blood cultures (at least 1 set following local guidelines).
- Suspected respiratory tract infection: sputum culture and/or throat culture.
- Conditions
- Respiratory Tract Infections, Urinary Tract Infections, Skin and Soft Tissue Infections, Intraabdominal Infections, Sepsis
- Being tested
- HostDx Sepsis
- Keywords
- Acute Infections, Host response, mRNA, diagnosis, prognosis, procalcitonin, c-reactive protein, molecular respiratory panel, adults
- Medical subject headings
- Respiratory Tract Infections, Urinary Tract Infections, Soft Tissue Infections, Intraabdominal Infections, Sepsis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HostDx SepsisDiagnostic test
Also called Procalcitonin, C-reactive protein, Molecular respiratory pathogen panel
Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of HostDx Sepsis diagnostic test read-out: likelihood of bacterial infection
Percent agreement of HostDx Sepsis bacterial readout with clinical adjudication by physician 30 days after enrollment for the presence of a bacterial infection
Measured: 30 days after enrollment
Concordance of HostDx Sepsis diagnostic test read-out: likelihood of viral infection
Percent agreement of HostDx Sepsis viral readout with clinical adjudication by physician 30 days after enrollment for the presence of a viral infection
Measured: 30 days after enrollment
Concordance of HostDx Sepsis prognostic read-out (severity) with patient outcome
Percent agreement between HostDx Sepsis severity readout and patient outcome, ie mortality, severity of infection, management of patient
Measured: 30 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start23 Jul 2018
- Primary completion25 Nov 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inflammatix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744741
- Sponsor's protocol ID
- OSCCCx-INF-02
- Status last verified
- Dec 2021
- First submitted
- 22 Jul 2018
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections: a Multicenter Pilot Study
- ClinicalTrials.gov ID
- NCT03744741
- Acronym / sponsor ID
- OSCCCx-INF-02
- Conditions
- Respiratory Tract Infections, Urinary Tract Infections, Skin and Soft Tissue Infections, Intraabdominal Infections, Sepsis
- Keywords
- Acute Infections, Host response, mRNA, diagnosis, prognosis, procalcitonin, c-reactive protein, molecular respiratory panel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- InflammatixIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Subjects presenting to the emergency department with a suspected acute infection will be eligible. Suspected infections may be of a) respiratory, b) urinary, c) intra-abdominal, or d) skin \& soft tissue etiology. Subjects with suspected sepsis of any cause will also be eligible.
Blood sample collections: Clinical study staff or the treating physician will obtain patient consent and collect two PAXgene RNA tubes of whole blood by venipuncture. The blood samples will be stored at room temperature overnight prior to being frozen at -80C for long-term storage. Samples will be shipped to the sponsor for testing using the HostDx Sepsis test. An additional tube of blood obtained via venipuncture and stored for shipment to a centralized testing laboratory, where it will be tested for C-reactive protein and procalcitonin. This will be done for all participants, even if they had these tests ordered locally as SOC.
In participants with suspected respiratory tract infections a nasopharyngeal swab will be collected as intervention and sent to the reference laboratory. The sample will be processed in a respiratory pathogen panel (regardless of whether the participants had or had not provided a nasopharyngeal swab for local testing with a respiratory panel as SOC).
Results obtained from microbiological testing of the following additional samples will be recorded if testing had been performed locally as SOC:
- Suspected urinary tract infection: Urine sample for culture.
- Suspected skin \& soft tissue infection: Swab from wound or abscess drainage, or other sample, for culture.
- Suspected intra-abdominal infection or abscesses (e.g. appendicitis, diverticulitis, cholecystitis): Swab, biopsy or other sample types for culture
- Suspected sepsis of any cause: blood cultures (at least 1 set following local guidelines).
- Suspected respiratory tract infection: sputum culture and/or throat culture.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the ED with acute infections or suspected sepsis
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HostDx SepsisAlso: Procalcitonin, C-reactive protein, Molecular respiratory pathogen panelBlood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection | Diagnostic test | – |
Primary outcome
Concordance of HostDx Sepsis diagnostic test read-out: likelihood of bacterial infection
Time frame: 30 days after enrollment
Percent agreement of HostDx Sepsis bacterial readout with clinical adjudication by physician 30 days after enrollment for the presence of a bacterial infection
Concordance of HostDx Sepsis diagnostic test read-out: likelihood of viral infection
Time frame: 30 days after enrollment
Percent agreement of HostDx Sepsis viral readout with clinical adjudication by physician 30 days after enrollment for the presence of a viral infection
Concordance of HostDx Sepsis prognostic read-out (severity) with patient outcome
Time frame: 30 days after enrollment
Percent agreement between HostDx Sepsis severity readout and patient outcome, ie mortality, severity of infection, management of patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infections and Urinary Tract Infections, run by Inflammatix at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of HostDx Sepsis diagnostic test read-out: likelihood of bacterial infection (time frame: 30 days after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.