Lower Respiratory Tract InfectionOBSERVERNCT03011515
Evaluating a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiology in Patients With Lower Respiratory Tract Infection (LRTI)
An observational study of Lower Respiratory Tract Infection and Acute Bronchitis, run by MeMed Diagnostics Ltd. at 1 site in Israel.
Trial summary
The purpose of this study is to validate the diagnostic accuracy of a novel host-response based diagnostic tool for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical suspicion of lower respiratory tract infections (LRTI) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Respiratory Tract Infection, Acute Bronchitis, Pneumonia
- How many people
- 583 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Mar 2017to 7 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include eligible patients aged 18 years and older of both genders that attend the emergency department or affiliated community clinics due to a suspected LRTI, or due to a non-infectious disease.
Who may be able to join
- Patients aged 18 years and older who agree (or their legal guardian agree) to sign an informed consent will be eligible for inclusion.
- The LRTI cohorts should also fulfill the following criteria:
- Peak measured (not tactile, self-reported acceptable) temperature ≥ 37.8°C (100°F) within the last 7 days (AND)
- Symptoms duration ≤7 days (AND)
- Clinical suspicion of LRTI or pneumonia
Who cannot join
- Oral/intravenous/intramuscular antibiotic treatment of over 48/12/12 hours' duration at time of enrollment (respectively), unless temperature ≥ 37.8°C was measured within the last 2 days
- Another episode of an acute infection during the last 2 weeks
- Congenital immune deficiency (CID)
- A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
- Active malignancy
- Pregnancy
Show all 18Show fewer
- Current treatment with immune-suppressive or immune-modulating therapies including without limitations:
- Use of high dose steroids >1 mg/kg/day prednisone or equivalent in the past two weeks
- Monoclonal antibodies
- Intravenous immunoglobulin (IVIG)
- Cyclosporine, Cyclophosphamide, Tacrolimus
- Granulocyte/Monocyte colony stimulating factor (G/GM-CSF)
- Anti-Tumor Necrosis Factor (TNF) agents
- Interferon (of all kinds)
- Other severe illnesses that affect life expectancy and quality of life such as:
- Moderate to severe psychomotor retardation
- Post-transplant patients (including solid organs, allogeneic/autologous stem cell transplantation)
- Moderate to severe congenital metabolic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Prospective, Validation Study to Assess the Accuracy of a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiology in Adult Patients With Lower Respiratory Tract Infections
The purpose of this study is to validate the diagnostic accuracy of a novel host-response based diagnostic tool for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical suspicion of lower respiratory tract infections (LRTI)
- Conditions
- Lower Respiratory Tract Infection, Acute Bronchitis, Pneumonia, Chronic Obstructive Pulmonary Disease (COPD), Upper Respiratory Tract Infection
- Medical subject headings
- Bronchitis, Pneumonia, Pulmonary Disease, Chronic Obstructive, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LRTI patients | Patients with suspicion of LRTI, excluding episodes of COPD exacerbations | |
| Non-infectious patients | Afebrile patients with no apparent infectious disease | |
| LRTI patients with COPD | Patients with suspicion of LRTI in a sub-group of patients with COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
To externally validate the diagnostic accuracy of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical suspicion of LRTI
Measured: 0-6 days after the initiation of symptoms
Secondary outcomes (4)
To compare the diagnostic accuracy of ImmunoXpert™ to currently available lab measures (WBC, ANC, PCT, CRP), using sensitivity and specificity measures and predetermined cutoffs
Measured: 0-6 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: 0-6 days after the initiation of symptoms
To estimate the potential improvement in health and economic outcomes following the usage of ImmunoXpert™ compared to current practice
Measured: 0-6 days after the initiation of symptoms
To estimate the diagnostic accuracy of ImmunoXpert™ in differentiating between infectious vs non-infectious patients
Measured: 0-6 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 posted5 Jan 2017 (estimated)
- Study start10 Mar 2017
- Primary completion1 Jan 2018
- Study completion7 Jan 2020
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 Lower Respiratory Tract InfectionStudies 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
- 583 participants (actual)
Sponsor and investigators
- Lead sponsor
- MeMed Diagnostics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus, Carmel Medical Center, Rabin Medical Center, European Commission
- Responsible party
- Sponsor
- Investigators
- Mical Paul, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011515
- Sponsor's protocol ID
- MM-1005-OB
- Acronym
- OBSERVER
- Status last verified
- Oct 2021
- First submitted
- 4 Jan 2017
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- 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, Validation Study to Assess the Accuracy of a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiology in Adult Patients With Lower Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT03011515
- Acronym / sponsor ID
- OBSERVER / MM-1005-OB
- Conditions
- Lower Respiratory Tract Infection, Acute Bronchitis, Pneumonia, Chronic Obstructive Pulmonary Disease (COPD), Upper Respiratory Tract Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 583 participants (actual)
- Lead sponsor
- MeMed Diagnostics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus, Carmel Medical Center, Rabin Medical Center, European Commission
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 5 Jan 2017 (estimated)
- 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.
The purpose of this study is to validate the diagnostic accuracy of a novel host-response based diagnostic tool for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical suspicion of lower respiratory tract infections (LRTI)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LRTI patients | – | –Patients with suspicion of LRTI, excluding episodes of COPD exacerbations |
| Non-infectious patients | – | –Afebrile patients with no apparent infectious disease |
| LRTI patients with COPD | – | –Patients with suspicion of LRTI in a sub-group of patients with COPD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include eligible patients aged 18 years and older of both genders that attend the emergency department or affiliated community clinics due to a suspected LRTI, or due to a non-infectious disease.
Key inclusion criteria (5 listed)
- Patients aged 18 years and older who agree (or their legal guardian agree) to sign an informed consent will be eligible for inclusion.
- The LRTI cohorts should also fulfill the following criteria:
Key exclusion criteria (18 listed)
- Oral/intravenous/intramuscular antibiotic treatment of over 48/12/12 hours' duration at time of enrollment (respectively), unless temperature ≥ 37.8°C was measured within the last 2 days
- Another episode of an acute infection during the last 2 weeks
- Congenital immune deficiency (CID)
- A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV), or hepatitis C virus (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 externally validate the diagnostic accuracy of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical suspicion of LRTI
Time frame: 0-6 days after the initiation of symptoms
4 secondary outcomes
To compare the diagnostic accuracy of ImmunoXpert™ to currently available lab measures (WBC, ANC, PCT, CRP), using sensitivity and specificity measures and predetermined cutoffs
Time frame: 0-6 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: 0-6 days after the initiation of symptoms
To estimate the potential improvement in health and economic outcomes following the usage of ImmunoXpert™ compared to current practice
Time frame: 0-6 days after the initiation of symptoms
To estimate the diagnostic accuracy of ImmunoXpert™ in differentiating between infectious vs non-infectious patients
Time frame: 0-6 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.
- Related InfoLink provided by the sponsor.
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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.
Mical Paul, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Respiratory Tract Infection and Acute Bronchitis, run by MeMed Diagnostics Ltd. at 1 site in Israel.
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 5 inclusion and 18 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 1 site in Israel. 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 externally validate the diagnostic accuracy of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical suspicion of LRTI (time frame: 0-6 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 NCT03011515, 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.