Viral InfectionROSETTANCT04254991
A Controlled, Blinded Study to Validate the Diagnostic Accuracy and Assess the Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the ED With Suspicion of Acute Infection
An observational study of Viral Infection and Bacterial Infections, run by MeMed Diagnostics Ltd..
Trial summary
To externally validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in pediatric patients >3 months old with suspicion of Respiratory tract infection (RTI) or Fever without Source (FWS) Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Viral Infection, Bacterial Infections, Antibiotic Misuse
- What is being tested?
- ImmunoXpert™
- How many people
- 525 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2016to May 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 3 months to 18 years
- All sexes
- Child, Adult
Study population: The study population will include eligible subjects from both genders that present to the ED due to suspected RTI, FWS, GE, UTI or non-febrile non-infectious disease (Control). Each of these subjects 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 mixed co-infection (bacterial and viral) 4. Patients with an undetermined disease etiology 5. Patients with a non-infectious disease (control group)
Who may be able to join
- Documented peak temperature ≥ 38°C (100.4°F) (AND)
- Symptom duration ≤ 7 days (AND)
- Clinical suspicion of RTI (OR)
- Fever without a clear source (OR)
- Acute gastroenteritis (OR)
- Urinary tract infection
Who cannot join
- Antibiotic treatment of over 48 hours' duration at time of presentation
- Another episode of febrile infection within the past 2 weeks
- A proven or suspected HIV1, HBV, or HCV infection
- Congenital immune deficiency (CID)
- Active malignancy
- Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:
Show all 14Show fewer
- 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 quality of life such as:
- Moderate to severe psychomotor retardation
- Post-transplant patients
- Moderate to severe congenital metabolic disorder
About this study
To externally validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in pediatric patients >3 months old with suspicion of Respiratory tract infection (RTI) or Fever without Source (FWS)
- Being tested
- ImmunoXpert™
- Medical subject headings
- Virus Diseases, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunoXpert™Diagnostic test
The ImmunoXpert™ technology employs a biochemical assay that measures a proprietary combination of three biomarkers of the immune system coupled with pattern recognition algorithms that classify the source of an infection as bacterial or viral
| Study group | Role | What they receive |
|---|---|---|
| Infectious disease group | Not described Receives: Diagnostic Test: ImmunoXpert™ | |
| Non-infectious disease group | Not described Receives: Diagnostic Test: ImmunoXpert™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
ImmunoXpert™ Diagnostic Performance
Sensitivity and specificity of ImmunoXpert™ in differentiating between bacterial and viral etiologies of pediatric patients >3 months old with suspicion of RTI or FWS
Measured: Through study completion, an average of 3 years
Secondary outcomes (2)
ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Gastroenteritis
Sensitivity and specificity of ImmunoXpert in differentiating between bacterial and viral etiologies of pediatric patients >3 months old with GE.
Measured: Through study completion, an average of 3 years
ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Urinary Tract Infection
Sensitivity and specificity of ImmunoXpert in differentiating between bacterial and viral etiologies of pediatric patients >3 months old with UTI.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start30 May 2016
- Primary completionMay 2018
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral 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
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- MeMed Diagnostics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Schneider Children's Medical Center, Israel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254991
- Sponsor's protocol ID
- 0666-15-RMC
- Acronym
- ROSETTA
- Status last verified
- Feb 2020
- First submitted
- 7 Jan 2020
- Last updated
- 5 Feb 2020
- 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Blinded Study to Validate the Diagnostic Accuracy and Assess the Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the ED With Suspicion of Acute Infection
- ClinicalTrials.gov ID
- NCT04254991
- Acronym / sponsor ID
- ROSETTA / 0666-15-RMC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 525 participants (actual)
- Lead sponsor
- MeMed Diagnostics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Schneider Children's Medical Center, Israel
- Study start
- 30 May 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2020 (estimated)
- First posted
- 5 Feb 2020 (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.
To externally validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in pediatric patients >3 months old with suspicion of Respiratory tract infection (RTI) or Fever without Source (FWS)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infectious disease group | – | Diagnostic Test: ImmunoXpert™ |
| Non-infectious disease group | – | Diagnostic Test: ImmunoXpert™ |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The study population will include eligible subjects from both genders that present to the ED due to suspected RTI, FWS, GE, UTI or non-febrile non-infectious disease (Control). Each of these subjects 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 mixed co-infection (bacterial and viral) 4. Patients with an undetermined disease etiology 5. Patients with a non-infectious disease (control group)
Key inclusion criteria (6 listed)
- Documented peak temperature ≥ 38°C (100.4°F) (AND)
- Symptom duration ≤ 7 days (AND)
- Clinical suspicion of RTI (OR)
- Fever without a clear source (OR)
- Acute gastroenteritis (OR)
Key exclusion criteria (14 listed)
- Antibiotic treatment of over 48 hours' duration at time of presentation
- Another episode of febrile infection within the past 2 weeks
- A proven or suspected HIV1, HBV, or HCV infection
- Congenital immune deficiency (CID)
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunoXpert™The ImmunoXpert™ technology employs a biochemical assay that measures a proprietary combination of three biomarkers of the immune system coupled with pattern recognition algorithms that classify the source of an infection as bacterial or viral | Diagnostic test | Infectious disease group, Non-infectious disease group |
Primary outcome
ImmunoXpert™ Diagnostic Performance
Time frame: Through study completion, an average of 3 years
Sensitivity and specificity of ImmunoXpert™ in differentiating between bacterial and viral etiologies of pediatric patients >3 months old with suspicion of RTI or FWS
2 secondary outcomes
ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Gastroenteritis
Time frame: Through study completion, an average of 3 years
ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Urinary Tract Infection
Time frame: Through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Infection and Bacterial Infections, run by MeMed Diagnostics Ltd..
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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 5 Feb 2020. 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?
Results are not available in the source record.
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?
ImmunoXpert™ Diagnostic Performance (time frame: Through study completion, an average of 3 years). 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 5 Feb 2020; AzTrials last refreshed its copy on 28 Oct 2026.