FeverAutoPilotNCT03052088
Diagnostic Accuracy of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients
An observational study of Fever and Respiratory Tract Infections, run by MeMed Diagnostics Ltd. at 2 sites in 2 countries.
Trial summary
This is a prospective clinical validation study of a novel regulatory approved (CE-IVD) diagnostic assay called ImmunoXpert™ that will enroll 1222 pediatric patients. The study aims to externally validate the tool's diagnostic accuracy and estimate the potential improvement in health and economic outcomes following… Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Fever, Respiratory Tract Infections
- How many people
- 1,140 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Feb 2017to 1 Aug 2019
- 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 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Eligible subjects from both genders that present to the ED due to suspected RTI, or FWS. Each of these patients falls into one of the following categories: 1. Patients with an acute bacterial infection 2. Patients with an acute viral infection 3. Patients with an acute co-infection (bacterial and viral) 4. Patients with an undetermined disease etiology
Who may be able to join
- Legal guardian signs an informed consent
- Documented peak temperature ≥ 38°C (100.4°F)
- Symptom duration ≤ 7 days
- Clinical suspicion of RTI (OR) fever without a clear source after clinical examination
Who cannot join
- Another episode of febrile infection within the past 2 weeks
- Antibiotic treatment of over 48 hours
- Congenital immune deficiency (CID)
- A proven or suspected HIV, HBV, HCV infection
- Active malignancy
- Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:
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- Use of high dose steroids >1 mg/kg/day prednisone or equivalent in the past two weeks
- Monoclonal antibodies, anti-TNF agents
- Intravenous immunoglobulin (IVIG)
- Cyclosporine, Cyclophosphamide, Tacrolimus
- G/GM-CSF, Interferons
- Other severe illnesses that affect life expectancy and/or quality of life such as:
- Severe psychomotor retardation
- Post-transplant patients
- Severe congential metabolic disorder
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multi-center, Prospective, Pilot Study to Validate the Diagnostic Accuracy and Assess the Potential Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the Emergency Department With Respiratory Tract Infection (RTI) or Fever Without Source (FWS)
This is a prospective clinical validation study of a novel regulatory approved (CE-IVD) diagnostic assay called ImmunoXpert™ that will enroll 1222 pediatric patients. The study aims to externally validate the tool's diagnostic accuracy and estimate the potential improvement in health and economic outcomes following the usage of ImmunoXpert™. Additionally, statistical analysis will be performed to compare ImmunoXpert™ accuracy to current practice lab testing (e.g. WBC, CRP, and PCT) and clinical suspicion at time of requisition. Enrolled patients will be managed according to the current standard of care and per standard institutional procedures.
- Conditions
- Fever, Respiratory Tract Infections
- Medical subject headings
- Fever, Respiratory Tract Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool, for differentiating between bacterial and viral etiologies in pediatric patients >90 days old with suspicion of RTI or FWS
Measured: 0-7 days after the initiation of symptoms
Secondary outcomes (2)
To compare the diagnostic accuracy of a host-response based diagnostic to currently available lab measures (WBC, ANC, CRP and PCT), using sensitivity and specificity measures and predetermined cutoffs
Measured: 0-7 days after the initiation of symptoms
To compare ImmunoXpert™ results with the physician suspected diagnosis at time of patient recruitment and compared to the reference standard diagnosis
Measured: 0-7 days after the initiation of symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start6 Feb 2017
- Primary completion1 Jun 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FeverStudies 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
- 1,140 participants (actual)
Sponsor and investigators
- Lead sponsor
- MeMed Diagnostics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Commission, Heidelberg University, University of Parma
- Responsible party
- Sponsor
- Investigators
- Tobias Tenenbaum, MD, Principal investigator, Kinderklinik Universitatsmedizine mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052088
- Sponsor's protocol ID
- MM-1006-AP
- Acronym
- AutoPilot
- Status last verified
- Oct 2021
- First submitted
- 10 Feb 2017
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oved K, Cohen A, Boico O, Navon R, Friedman T, Etshtein L, Kriger O, Bamberger E, Fonar Y, Yacobov R, Wolchinsky R, Denkberg G, Dotan Y, Hochberg A, Reiter Y, Grupper M, Srugo I, Feigin P, Gorfine M, Chistyakov I, Dagan R, Klein A, Potasman I, Eden E. A novel host-proteome signature for distinguishing between acute bacterial and viral infections. PLoS One. 2015 Mar 18;10(3):e0120012. doi: 10.1371/journal.pone.0120012. eCollection 2015.
PubMed 25785720Eden E, Srugo I, Gottlieb T, Navon R, Boico O, Cohen A, Bamberger E, Klein A, Oved K. Diagnostic accuracy of a TRAIL, IP-10 and CRP combination for discriminating bacterial and viral etiologies at the Emergency Department. J Infect. 2016 Aug;73(2):177-80. doi: 10.1016/j.jinf.2016.05.002. Epub 2016 May 30. No abstract available.
PubMed 27255416van Houten CB, de Groot JAH, Klein A, Srugo I, Chistyakov I, de Waal W, Meijssen CB, Avis W, Wolfs TFW, Shachor-Meyouhas Y, Stein M, Sanders EAM, Bont LJ. A host-protein based assay to differentiate between bacterial and viral infections in preschool children (OPPORTUNITY): a double-blind, multicentre, validation study. Lancet Infect Dis. 2017 Apr;17(4):431-440. doi: 10.1016/S1473-3099(16)30519-9. Epub 2016 Dec 22.
PubMed 28012942
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Pilot Study to Validate the Diagnostic Accuracy and Assess the Potential Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the Emergency Department With Respiratory Tract Infection (RTI) or Fever Without Source (FWS)
- ClinicalTrials.gov ID
- NCT03052088
- Acronym / sponsor ID
- AutoPilot / MM-1006-AP
- Conditions
- Fever, Respiratory Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,140 participants (actual)
- Lead sponsor
- MeMed Diagnostics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- European Commission, Heidelberg University, University of Parma
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 14 Feb 2017 (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 is a prospective clinical validation study of a novel regulatory approved (CE-IVD) diagnostic assay called ImmunoXpert™ that will enroll 1222 pediatric patients. The study aims to externally validate the tool's diagnostic accuracy and estimate the potential improvement in health and economic outcomes following the usage of ImmunoXpert™. Additionally, statistical analysis will be performed to compare ImmunoXpert™ accuracy to current practice lab testing (e.g. WBC, CRP, and PCT) and clinical suspicion at time of requisition. Enrolled patients will be managed according to the current standard of care and per standard institutional procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible subjects from both genders that present to the ED due to suspected RTI, or FWS. Each of these patients falls into one of the following categories: 1. Patients with an acute bacterial infection 2. Patients with an acute viral infection 3. Patients with an acute co-infection (bacterial and viral) 4. Patients with an undetermined disease etiology
Key inclusion criteria (4 listed)
- Legal guardian signs an informed consent
- Documented peak temperature ≥ 38°C (100.4°F)
- Symptom duration ≤ 7 days
- Clinical suspicion of RTI (OR) fever without a clear source after clinical examination
Key exclusion criteria (15 listed)
- Another episode of febrile infection within the past 2 weeks
- Antibiotic treatment of over 48 hours
- Congenital immune deficiency (CID)
- A proven or suspected HIV, HBV, HCV infection
- Active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool, for differentiating between bacterial and viral etiologies in pediatric patients >90 days old with suspicion of RTI or FWS
Time frame: 0-7 days after the initiation of symptoms
2 secondary outcomes
To compare the diagnostic accuracy of a host-response based diagnostic to currently available lab measures (WBC, ANC, CRP and PCT), using sensitivity and specificity measures and predetermined cutoffs
Time frame: 0-7 days after the initiation of symptoms
To compare ImmunoXpert™ results with the physician suspected diagnosis at time of patient recruitment and compared to the reference standard diagnosis
Time frame: 0-7 days after the initiation of symptoms
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 12 Oct 2021.
- Background: PubMed 25785720Oved K, Cohen A, Boico O, Navon R, Friedman T, Etshtein L, Kriger O, Bamberger E, Fonar Y, Yacobov R, Wolchinsky R, Denkberg G, Dotan Y, Hochberg A, Reiter Y, Grupper M, Srugo I, Feigin P, Gorfine M, Chistyakov I, Dagan R, Klein A, Potasman I, Eden E. A novel host-proteome signature for distinguishing between acute bacterial and viral infections. PLoS One. 2015 Mar 18;10(3):e0120012. doi: 10.1371/journal.pone.0120012. eCollection 2015.
- Background: PubMed 27255416Eden E, Srugo I, Gottlieb T, Navon R, Boico O, Cohen A, Bamberger E, Klein A, Oved K. Diagnostic accuracy of a TRAIL, IP-10 and CRP combination for discriminating bacterial and viral etiologies at the Emergency Department. J Infect. 2016 Aug;73(2):177-80. doi: 10.1016/j.jinf.2016.05.002. Epub 2016 May 30. No abstract available.
- Background: PubMed 28012942van Houten CB, de Groot JAH, Klein A, Srugo I, Chistyakov I, de Waal W, Meijssen CB, Avis W, Wolfs TFW, Shachor-Meyouhas Y, Stein M, Sanders EAM, Bont LJ. A host-protein based assay to differentiate between bacterial and viral infections in preschool children (OPPORTUNITY): a double-blind, multicentre, validation study. Lancet Infect Dis. 2017 Apr;17(4):431-440. doi: 10.1016/S1473-3099(16)30519-9. Epub 2016 Dec 22.
- 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.
Tobias Tenenbaum, MD principal investigator
Kinderklinik Universitatsmedizine mannheim
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever and Respiratory Tract Infections, run by MeMed Diagnostics Ltd. at 2 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 4 inclusion and 15 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 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Italy. 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?
To validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool, for differentiating between bacterial and viral etiologies in pediatric patients >90 days old with suspicion of RTI or FWS (time frame: 0-7 days after the initiation of symptoms). 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 NCT03052088, which also lists 3 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 12 Oct 2021.