Respiratory Tract InfectionsNCT05639504

Sepsis Prognosis and Diagnosis in the Emergency Department (SPEED)

An observational study of Respiratory Tract Infections and Urinary Tract Infections, run by Inflammatix.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

This study aims to evaluate the diagnostic and prognostic performance of a novel mRNA diagnostic/prognostic classifier (interprets the expression of 29 host response mRNA biomarkers) from whole blood in adult patients presenting to emergency departments (ED) with suspected infection. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Respiratory Tract Infections, Urinary Tract Infections, Intra-Abdominal Infections
What is being tested?: IMX-BVN-4 and IMX-SEV-4
How many people: 0 participants
Where: No sites listed yet
Study dates: Dec 2022to May 2023
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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Adult participants (16 years and older) presenting to the ED (or related assessment and treatment facilities such as SDEC or AMU) with clinically suspected infection of any aetiology as the reason for attendance and a NEWS2 score of ≥2 (any dimension, using latest score)

Who may be able to join

Adult participants (16 years and older) presenting to the ED (or related assessment and treatment facilities such as SDEC or AMU) with:
Clinically suspected infection of any aetiology as the reason for attendance; AND
NEWS2 score of ≥2 (any dimension, using latest score)

Who cannot join

Treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to the ED visit. Participants will not be excluded for use of:
Antiviral treatment for HIV infection and hepatitis B and hepatitis C
Topical antibiotics, topical antiviral or topical antifungal agents
Anti-herpes prophylaxis aiding suppression of a recuring herpes infection
Peri-operative (prophylactic) antibiotics
A single dose of antimicrobials during the present ED visit; note single dose can be considered mono- or combination therapy, wherein combination is administered as part of local Standard of Care and only one dose of each medication is administered

Show all 10Show fewer

Presence of an advance directive to withhold life-sustaining treatment or a clear plan in place to that effect (ie. an explicit decision by patient/family/carer in conjunction with clinical team that active treatment beyond symptomatic relief is not appropriate). Note that patients who do not wish to receive cardiopulmonary resuscitation (CPR) but active treatment is still indicated may still qualify for entry into study
Prisoners or those in police custody
Patients who permanently lack the capacity to give informed consent
Previously enrolled in SPEED UK study

About this study

Official title: Sepsis Prognosis and Diagnosis in the Emergency Department Using a Host Response Classifier (SPEED) UK - a Multi-Centre Observational Study

Read the detailed description

Study measurements consists of a blood collection via venepuncture into a PAXgene® Blood RNA tube (2.5 ml) and Na-Heparin tube (4 ml) normally within 1 hour of enrolment into the study. The samples will be stored and transferred in batches from recruiting centres to a core laboratory. The expression of 29 mRNAs contained in the IMX-BVN-4/SEV-4 classifier will be analysed to determine the likelihood of bacterial and viral infection, as well as the likelihood of clinical deterioration. A nasopharyngeal swab sample will also be obtained for participants with suspected respiratory tract infection. Clinical data collection will be recorded from source data using an electronic Case Report Form (eCRF) The diagnosis of infection will be confirmed by a clinical adjudication panel blinded to the ED and hospital discharge diagnosis for each case.

Conditions: Respiratory Tract Infections, Urinary Tract Infections, Intra-Abdominal Infections, Skin and Soft Tissue Infection, Suspected Meningitis/Encephalitis or Any Other Infection, Sepsis
Being tested: IMX-BVN-4 and IMX-SEV-4
Keywords: Infection, mRNA, host response
Medical subject headings: Respiratory Tract Infections, Urinary Tract Infections, Intraabdominal Infections, Soft Tissue Infections, Encephalitis, Sepsis, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IMX-BVN-4 and IMX-SEV-4Diagnostic test
Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection

Study groups in NCT05639504
Study group	Role	What they receive
NEWS2 score of 2-4		Bio-sample collection Receives: Diagnostic Test: IMX-BVN-4 and IMX-SEV-4
NEWS2 score of 5-6		Bio-sample collection Receives: Diagnostic Test: IMX-BVN-4 and IMX-SEV-4
NEWS2 score of ≥7		Bio-sample collection Receives: Diagnostic Test: IMX-BVN-4 and IMX-SEV-4

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Outcome 1
Performance of the host response classifier IMX-BVN-4 to diagnose bacterial and viral infection as compared to clinical adjudication (sensitivity, specificity, likelihood ratios).
Measured: Admission
Primary Outcome 2
Prognostic performance of IMX-SEV-4 using an endpoint of receipt of critical-level care (including requirement for admission to critical care, mechanical ventilation, vasopressors (>12 hours), or renal replacement therapy) within 7 days (sensitivity, specificity, likelihood ratios).
Measured: Within 7 days after admission

Secondary outcomes (3)

Secondary Outcome 1
Prognostic performance of IMX-SEV-4 using a composite endpoint of Receipt of critical-level care (including requirement for transfer to critical care, mechanical ventilation, vasopressors (>12 hours), or renal replacement therapy) within 7 days, and/or 28-day in-hospital mortality (sensitivity, specificity, likelihood ratios).
Measured: Up to 28 days after admission
Secondary Outcome 2
Diagnostic performance of the IMX-BVN-4 classifier in determining bacterial and viral infection compared with other biomarkers (procalcitonin and lactate) and clinical or laboratory findings obtained from standard of care, as compared to clinical adjudication (sensitivity, specificity, likelihood ratios).
Measured: Admission
Secondary Outcome 3
Prognostic performance of IMX-SEV-4 for clinical deterioration (NEWS2 of 5 or higher) within 7 days (sensitivity, specificity, likelihood ratios).
Measured: Within 7 days after admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2022May 2023

First posted6 Dec 2022
Study startDec 2022 (estimated)
Primary completionApr 2023 (estimated)
Study completionMay 2023 (estimated)

Why it stopped: Study never started, change in company focus on US

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
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: Cohort
Time perspective: Prospective
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05639504
Sponsor's protocol ID: INF-25
Status last verified: Dec 2023
First submitted: 27 Sep 2022
Last updated: 27 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gaieski DF, Mikkelsen ME, Band RA, Pines JM, Massone R, Furia FF, Shofer FS, Goyal M. Impact of time to antibiotics on survival in patients with severe sepsis or septic shock in whom early goal-directed therapy was initiated in the emergency department. Crit Care Med. 2010 Apr;38(4):1045-53. doi: 10.1097/CCM.0b013e3181cc4824.
PubMed 20048677
Galtung N, Diehl-Wiesenecker E, Lehmann D, Markmann N, Bergstrom WH, Wacker J, Liesenfeld O, Mayhew M, Buturovic L, Luethy R, Sweeney TE, Tauber R, Kappert K, Somasundaram R, Bauer W. Prospective validation of a transcriptomic severity classifier among patients with suspected acute infection and sepsis in the emergency department. Eur J Emerg Med. 2022 Oct 1;29(5):357-365. doi: 10.1097/MEJ.0000000000000931. Epub 2022 Apr 21.
PubMed 35467566
Bauer W, Kappert K, Galtung N, Lehmann D, Wacker J, Cheng HK, Liesenfeld O, Buturovic L, Luethy R, Sweeney TE, Tauber R, Somasundaram R. A Novel 29-Messenger RNA Host-Response Assay From Whole Blood Accurately Identifies Bacterial and Viral Infections in Patients Presenting to the Emergency Department With Suspected Infections: A Prospective Observational Study. Crit Care Med. 2021 Oct 1;49(10):1664-1673. doi: 10.1097/CCM.0000000000005119.
PubMed 34166284
Brakenridge SC, Chen UI, Loftus T, Ungaro R, Dirain M, Kerr A, Zhong L, Bacher R, Starostik P, Ghita G, Midic U, Darden D, Fenner B, Wacker J, Efron PA, Liesenfeld O, Sweeney TE, Moldawer LL. Evaluation of a Multivalent Transcriptomic Metric for Diagnosing Surgical Sepsis and Estimating Mortality Among Critically Ill Patients. JAMA Netw Open. 2022 Jul 1;5(7):e2221520. doi: 10.1001/jamanetworkopen.2022.21520.
PubMed 35819783
Brakenridge SC, Starostik P, Ghita G, Midic U, Darden D, Fenner B, Wacker J, Efron PA, Liesenfeld O, Sweeney TE, Moldawer LL. A Transcriptomic Severity Metric That Predicts Clinical Outcomes in Critically Ill Surgical Sepsis Patients. Crit Care Explor. 2021 Oct 14;3(10):e0554. doi: 10.1097/CCE.0000000000000554. eCollection 2021 Oct.
PubMed 34671746
Sweeney TE, Shidham A, Wong HR, Khatri P. A comprehensive time-course-based multicohort analysis of sepsis and sterile inflammation reveals a robust diagnostic gene set. Sci Transl Med. 2015 May 13;7(287):287ra71. doi: 10.1126/scitranslmed.aaa5993.
PubMed 25972003
Sweeney TE, Wong HR, Khatri P. Robust classification of bacterial and viral infections via integrated host gene expression diagnostics. Sci Transl Med. 2016 Jul 6;8(346):346ra91. doi: 10.1126/scitranslmed.aaf7165.
PubMed 27384347
Sweeney TE, Perumal TM, Henao R, Nichols M, Howrylak JA, Choi AM, Bermejo-Martin JF, Almansa R, Tamayo E, Davenport EE, Burnham KL, Hinds CJ, Knight JC, Woods CW, Kingsmore SF, Ginsburg GS, Wong HR, Parnell GP, Tang B, Moldawer LL, Moore FE, Omberg L, Khatri P, Tsalik EL, Mangravite LM, Langley RJ. A community approach to mortality prediction in sepsis via gene expression analysis. Nat Commun. 2018 Feb 15;9(1):694. doi: 10.1038/s41467-018-03078-2.
PubMed 29449546
Sweeney TE, Khatri P. Benchmarking Sepsis Gene Expression Diagnostics Using Public Data. Crit Care Med. 2017 Jan;45(1):1-10. doi: 10.1097/CCM.0000000000002021.
PubMed 27681387

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Enrolling by invitation
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All Respiratory Tract Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sepsis Prognosis and Diagnosis in the Emergency Department Using a Host Response Classifier (SPEED) UK - a Multi-Centre Observational Study
ClinicalTrials.gov ID: NCT05639504
Acronym / sponsor ID: INF-25
Conditions: Respiratory Tract Infections, Urinary Tract Infections, Intra-Abdominal Infections, Skin and Soft Tissue Infection, Suspected Meningitis/Encephalitis or Any Other Infection, Sepsis
Keywords: Infection, mRNA, host response
Study type: Observational
Recruitment status: WithdrawnReason stopped: Study never started, change in company focus on US
Enrolment: 0 participants (actual)
Lead sponsor: InflammatixIndustry (pharma, biotech, devices)
Study start: Dec 2022 (estimated)
Primary completion: Apr 2023 (estimated)
Study completion: May 2023 (estimated)
First posted: 6 Dec 2022 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
NEWS2 score of 2-4	–	Diagnostic Test: IMX-BVN-4 and IMX-SEV-4Bio-sample collection
NEWS2 score of 5-6	–	Diagnostic Test: IMX-BVN-4 and IMX-SEV-4Bio-sample collection
NEWS2 score of ≥7	–	Diagnostic Test: IMX-BVN-4 and IMX-SEV-4Bio-sample collection

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Adult participants (16 years and older) presenting to the ED (or related assessment and treatment facilities such as SDEC or AMU) with clinically suspected infection of any aetiology as the reason for attendance and a NEWS2 score of ≥2 (any dimension, using latest score)

Key inclusion criteria (3 listed)

Adult participants (16 years and older) presenting to the ED (or related assessment and treatment facilities such as SDEC or AMU) with:
Clinically suspected infection of any aetiology as the reason for attendance; AND
NEWS2 score of ≥2 (any dimension, using latest score)

Key exclusion criteria (10 listed)

Treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to the ED visit. Participants will not be excluded for use of:
Presence of an advance directive to withhold life-sustaining treatment or a clear plan in place to that effect (ie. an explicit decision by patient/family/carer in conjunction with clinical team that active treatment beyond symptomatic relief is not appropriate). Note that patients who do not wish to receive cardiopulmonary resuscitation (CPR) but active treatment is still indicated may still qualify for entry into study
Prisoners or those in police custody
Patients who permanently lack the capacity to give informed consent
Previously enrolled in SPEED UK study

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
IMX-BVN-4 and IMX-SEV-4Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection	Diagnostic test	NEWS2 score of 2-4, NEWS2 score of 5-6, NEWS2 score of ≥7

Primary outcome

Primary Outcome 1
Time frame: Admission
Performance of the host response classifier IMX-BVN-4 to diagnose bacterial and viral infection as compared to clinical adjudication (sensitivity, specificity, likelihood ratios).
Primary Outcome 2
Time frame: Within 7 days after admission
Prognostic performance of IMX-SEV-4 using an endpoint of receipt of critical-level care (including requirement for admission to critical care, mechanical ventilation, vasopressors (>12 hours), or renal replacement therapy) within 7 days (sensitivity, specificity, likelihood ratios).

3 secondary outcomes

Secondary Outcome 1
Time frame: Up to 28 days after admission
Secondary Outcome 2
Time frame: Admission
Secondary Outcome 3
Time frame: Within 7 days after admission

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
Background: PubMed 20048677Gaieski DF, Mikkelsen ME, Band RA, Pines JM, Massone R, Furia FF, Shofer FS, Goyal M. Impact of time to antibiotics on survival in patients with severe sepsis or septic shock in whom early goal-directed therapy was initiated in the emergency department. Crit Care Med. 2010 Apr;38(4):1045-53. doi: 10.1097/CCM.0b013e3181cc4824.
Background: PubMed 35467566Galtung N, Diehl-Wiesenecker E, Lehmann D, Markmann N, Bergstrom WH, Wacker J, Liesenfeld O, Mayhew M, Buturovic L, Luethy R, Sweeney TE, Tauber R, Kappert K, Somasundaram R, Bauer W. Prospective validation of a transcriptomic severity classifier among patients with suspected acute infection and sepsis in the emergency department. Eur J Emerg Med. 2022 Oct 1;29(5):357-365. doi: 10.1097/MEJ.0000000000000931. Epub 2022 Apr 21.
Background: PubMed 34166284Bauer W, Kappert K, Galtung N, Lehmann D, Wacker J, Cheng HK, Liesenfeld O, Buturovic L, Luethy R, Sweeney TE, Tauber R, Somasundaram R. A Novel 29-Messenger RNA Host-Response Assay From Whole Blood Accurately Identifies Bacterial and Viral Infections in Patients Presenting to the Emergency Department With Suspected Infections: A Prospective Observational Study. Crit Care Med. 2021 Oct 1;49(10):1664-1673. doi: 10.1097/CCM.0000000000005119.
Background: PubMed 35819783Brakenridge SC, Chen UI, Loftus T, Ungaro R, Dirain M, Kerr A, Zhong L, Bacher R, Starostik P, Ghita G, Midic U, Darden D, Fenner B, Wacker J, Efron PA, Liesenfeld O, Sweeney TE, Moldawer LL. Evaluation of a Multivalent Transcriptomic Metric for Diagnosing Surgical Sepsis and Estimating Mortality Among Critically Ill Patients. JAMA Netw Open. 2022 Jul 1;5(7):e2221520. doi: 10.1001/jamanetworkopen.2022.21520.
Background: PubMed 34671746Brakenridge SC, Starostik P, Ghita G, Midic U, Darden D, Fenner B, Wacker J, Efron PA, Liesenfeld O, Sweeney TE, Moldawer LL. A Transcriptomic Severity Metric That Predicts Clinical Outcomes in Critically Ill Surgical Sepsis Patients. Crit Care Explor. 2021 Oct 14;3(10):e0554. doi: 10.1097/CCE.0000000000000554. eCollection 2021 Oct.
Background: PubMed 25972003Sweeney TE, Shidham A, Wong HR, Khatri P. A comprehensive time-course-based multicohort analysis of sepsis and sterile inflammation reveals a robust diagnostic gene set. Sci Transl Med. 2015 May 13;7(287):287ra71. doi: 10.1126/scitranslmed.aaa5993.
Background: PubMed 27384347Sweeney TE, Wong HR, Khatri P. Robust classification of bacterial and viral infections via integrated host gene expression diagnostics. Sci Transl Med. 2016 Jul 6;8(346):346ra91. doi: 10.1126/scitranslmed.aaf7165.
Background: PubMed 29449546Sweeney TE, Perumal TM, Henao R, Nichols M, Howrylak JA, Choi AM, Bermejo-Martin JF, Almansa R, Tamayo E, Davenport EE, Burnham KL, Hinds CJ, Knight JC, Woods CW, Kingsmore SF, Ginsburg GS, Wong HR, Parnell GP, Tang B, Moldawer LL, Moore FE, Omberg L, Khatri P, Tsalik EL, Mangravite LM, Langley RJ. A community approach to mortality prediction in sepsis via gene expression analysis. Nat Commun. 2018 Feb 15;9(1):694. doi: 10.1038/s41467-018-03078-2.
Background: PubMed 27681387Sweeney TE, Khatri P. Benchmarking Sepsis Gene Expression Diagnostics Using Public Data. Crit Care Med. 2017 Jan;45(1):1-10. doi: 10.1097/CCM.0000000000002021.
Individual participant dataSharing planned: No

Related trials for Respiratory Tract Infections

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
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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.

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Tract Infections and Urinary Tract Infections, run by Inflammatix.

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 3 inclusion and 10 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: withdrawn, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Primary Outcome 1 (time frame: Admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05639504, which also lists 9 linked publications.

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 27 Dec 2023.