FeverPATHFINDERNCT01911143
A Retrospective, Blinded Validation of a Host-response Based Diagnostics
An observational study of Fever and Respiratory Tract Infections, run by MeMed Diagnostics Ltd. at 2 sites in Israel.
Trial summary
This is a retrospective, blinded, external validation study of a novel in-vitro diagnostic (IVD) assay that will include samples that were previously collected from febrile pediatric patients. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Fever, Respiratory Tract Infections, Urinary Tract Infections
- How many people
- 600 participants
- Where
- 2 sitesIsrael
- Study dates
- Sep 2013to Aug 2015
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population will include patients aged 1 month to 18 years of age that were sampled both during emergency department (ED) visit or during hospitalization stay and were diagnosed with an acute infectious disease or a non-infectious disease. All samples are expected to fall 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 mixed co-infection (bacterial and viral) 4. Patients with a non-infectious disease (control group)
Who may be able to join
- The infectious disease samples should also fulfill the following criteria:
- The patient had a peak temperature ≥38°C (AND)
- Symptoms initiated ≤ 7 days before sampling
- The non-infectious disease control group will include:
- Patients with a non-infectious disease
Who cannot join
- Another infection episode during the last 3 weeks before sampling
- Congenital immune deficiency (CID)
- A proven or suspected HIV-1, HBV, HCV infection
- Active hematological malignancy
- Current treatment with immune-suppressive or immune-modulating
- Other illnesses that affect life expectancy and/or quality of life
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Retrospective, Blinded Validation Study to Assess the Accuracy of a Host-response Based Diagnostics for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients With an Acute Febrile Disease
This is a retrospective, blinded, external validation study of a novel in-vitro diagnostic (IVD) assay that will include samples that were previously collected from febrile pediatric patients. The investigated assay measures the levels of a few host-related, blood-based, bio-markers that will be integrated into a single score. Based on this score, each patient will be classified into one of three categories: (i) bacterial immune response, (ii) viral immune response, and (iii) marginal immune response. The assay prediction and the patient diagnosis will than be unveiled and compared to determine their level of concordance.
- Conditions
- Fever, Respiratory Tract Infections, Urinary Tract Infections, Gastroenteritis, Arthritis, Infectious
- Medical subject headings
- Fever, Respiratory Tract Infections, Urinary Tract Infections, Gastroenteritis, Arthritis, Infectious
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of the assay in differentiating between bacterial and viral etiology of patients with an acute febrile disease
We will evaluate the assay using the accuracy measures sensitivity and specificity of differentiating between bacterial and viral etiology of pediatric patients aged 1 month to 18 years with an acute febrile disease.
Measured: 0-7 days after the initiation of symptoms
Secondary outcomes (1)
The sensitivity and specificity of the assay in differentiating between infectious and non-infectious disease etiology.
We will evaluate the assay using the accuracy measures sensitivity and specificity of differentiating between infectious and non-infectious disease etiology in pediatric patients aged 1 month to 18 years.
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 posted30 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- MeMed Diagnostics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bnai Zion Medical Center, University Hospital, Geneva
- Responsible party
- Sponsor
- Investigators
- Kfir Oved, Dr., Study director, MeMed Diagnostics Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911143
- Sponsor's protocol ID
- MM-1002-BV
- Acronym
- PATHFINDER
- Status last verified
- Mar 2016
- First submitted
- 15 Jul 2013
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Blinded Validation Study to Assess the Accuracy of a Host-response Based Diagnostics for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients With an Acute Febrile Disease
- ClinicalTrials.gov ID
- NCT01911143
- Acronym / sponsor ID
- PATHFINDER / MM-1002-BV
- Conditions
- Fever, Respiratory Tract Infections, Urinary Tract Infections, Gastroenteritis, Arthritis, Infectious
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- MeMed Diagnostics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Bnai Zion Medical Center, University Hospital, Geneva
- Study start
- Sep 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Jul 2013 (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.
This is a retrospective, blinded, external validation study of a novel in-vitro diagnostic (IVD) assay that will include samples that were previously collected from febrile pediatric patients. The investigated assay measures the levels of a few host-related, blood-based, bio-markers that will be integrated into a single score. Based on this score, each patient will be classified into one of three categories: (i) bacterial immune response, (ii) viral immune response, and (iii) marginal immune response. The assay prediction and the patient diagnosis will than be unveiled and compared to determine their level of concordance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will include patients aged 1 month to 18 years of age that were sampled both during emergency department (ED) visit or during hospitalization stay and were diagnosed with an acute infectious disease or a non-infectious disease. All samples are expected to fall 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 mixed co-infection (bacterial and viral) 4. Patients with a non-infectious disease (control group)
Key inclusion criteria (5 listed)
- The patient had a peak temperature ≥38°C (AND)
- Symptoms initiated ≤ 7 days before sampling
- Patients with a non-infectious disease
Key exclusion criteria (6 listed)
- Another infection episode during the last 3 weeks before sampling
- Congenital immune deficiency (CID)
- A proven or suspected HIV-1, HBV, HCV infection
- Active hematological malignancy
- Current treatment with immune-suppressive or immune-modulating
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
The sensitivity and specificity of the assay in differentiating between bacterial and viral etiology of patients with an acute febrile disease
Time frame: 0-7 days after the initiation of symptoms
We will evaluate the assay using the accuracy measures sensitivity and specificity of differentiating between bacterial and viral etiology of pediatric patients aged 1 month to 18 years with an acute febrile disease.
1 secondary outcome
The sensitivity and specificity of the assay in differentiating between infectious and non-infectious disease etiology.
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 8 Mar 2016.
- 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.
Kfir Oved, Dr. study director
MeMed Diagnostics Ltd.
2 sites in 1 country: 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 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 6 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 8 Mar 2016. 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 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?
The sensitivity and specificity of the assay in differentiating between bacterial and viral etiology of patients with an acute febrile disease (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?
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 8 Mar 2016.