LRTICURIOSITYNCT01917461
Observational, Prospective Clinical Study to Evaluate Biomarkers as Indicators of Acute Bacterial or Viral Infections
An observational study of LRTI and UTI, run by MeMed Diagnostics Ltd. at 2 sites in Israel.
Trial summary
This is an observational prospective study of an in-vitro diagnostic (IVD) assay planned to enroll 632 subjects. The study will be conducted in two stages: Stage A is aimed at identifying individual biomarkers and constructing a multi-parametric diagnostic model, whereas Stage B is aimed at testing the… Read more about this study
- Who is it for?
- Ages 1 month and olderHealthy volunteers can take part
- Conditions the study is for
- LRTI, UTI, Gastroenteritis
- How many people
- 1,001 participants
- Where
- 2 sitesIsrael
- Study dates
- Sep 2010to Sep 2014
- 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 and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Eligible subjects aged one month of age and older from both genders that attend the hospital or the emergency room (ER) due to a suspected acute infectious disease or due to a non-infectious disease (e.g. Trauma).
Who may be able to join
- Patients who are at least one month old and are willing (either the subject or his legal guardian) to sign an informed consent will be eligible for inclusion. For the infectious and non-infectious disease groups, additional inclusion criteria have to be met. These will include:
- In the Infectious disease group:
- Peak fever >37.5°C (99.5°F)
- Clinical suspicion of an acute infectious disease
- Symptoms duration ≤ 12 days
- In the Non-infectious disease control group:
- A non-infectious disease or healthy individuals
Who cannot join
- Patients who will meet one or more of the following criteria will be excluded from the study:
- Evidence of another episode of acute infectious disease in the last two weeks
- Diagnosed congenital immune deficiency (CID)
- Current treatment with immunosuppressive therapy such as: Active chemotherapy,Post-transplant drugs,High dose steroids (>1 mg/kg/day prednisone or equivalent).
- Active radiotherapy
- Immune-modulating/suppressive drugs including monoclonal antibodies, intravenous immunoglobulin (IVIG), cyclosporine, and anti-TNF agents
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- Current treatment with immune stimulants such as: Interleukin (IL)-2, Granulocyte-Monocytes/Granulocyte colony-stimulating factor (GM/G-CSF),Interferon.
- An active hematological malignancy
- A diagnosis of myelodysplastic syndrome or myeloproliferative disease
- A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hillel Yaffe Hospital
Hadera, Israel, 38100
Bnei Zion Hospital
Haifa, Israel, 31048
About this study
Official title: Observational, Prospective Study to Evaluate Biomarkers as Indicators of Bacterial or Viral Infection During Acute Infectious Diseases
This is an observational prospective study of an in-vitro diagnostic (IVD) assay planned to enroll 632 subjects. The study will be conducted in two stages: Stage A is aimed at identifying individual biomarkers and constructing a multi-parametric diagnostic model, whereas Stage B is aimed at testing the multi-parametric diagnostic model using a fresh cohort of patients.
A collection of clinical, radiological and laboratory data will be gathered in order to establish a final diagnosis. Blood samples will be analyzed and the levels of approximately 700 and 250,000 biomarkers will be determined using immunoassays and molecular measurements respectively.
A final diagnosis will be determined based on a majority decision of a panel of three or more independent physicians. Based on the final diagnosis, the accuracy of individual biomarkers and combined sets of biomarkers for differentiating between distinct groups of patients will be evaluated.
- Conditions
- LRTI, UTI, Gastroenteritis, Systemic Infections/Bacteremia/Meningitis, Fever Without Source
- Medical subject headings
- Gastroenteritis, Toxemia
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of a multi-parametric diagnostic assay in differentiating between bacterial and viral etiology in patients with an acute infectious disease
We will evaluate the sensitivity and specificity of a multi-parametric diagnostic model, incorporating up to five different blood bio-markers in differentiating between bacterial and viral etiology in patients with an acute infectious disease.
Measured: 0-10 days after the initiation of symptoms
Secondary outcomes (2)
The sensitivity and specificity of individual biomarkers in differentiating between bacterial and viral etiology in patients with an acute infectious disease
We will evaluate the sensitivity and specificity of individual bio-markers in differentiating between bacterial and viral etiology in patients with an acute infectious disease.
Measured: 0-10 days after the initiation of symptoms
The sensitivity and specificity of a multi-parametric assay in differentiating between mixed (bacterial and viral co-infection) and pure viral infections in patients with an acute infectious disease
We will evaluate the sensitivity and specificity of a multi-parametric diagnostic assay incorporating up to five different blood bio-markers, in differentiating between mixed infection(bacterial and viral co-infection) and pure viral infection in patients with an acute infectious disease.
Measured: 0-10 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 posted6 Aug 2013 (estimated)
- Study startSep 2010
- Primary completionDec 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LRTIStudies 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
- 1,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- MeMed Diagnostics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kfir Oved, Dr., Study director, MeMed Diagnostics Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917461
- Sponsor's protocol ID
- MM-1001-BV
- Acronym
- CURIOSITY
- Status last verified
- Mar 2016
- First submitted
- 31 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
- Observational, Prospective Study to Evaluate Biomarkers as Indicators of Bacterial or Viral Infection During Acute Infectious Diseases
- ClinicalTrials.gov ID
- NCT01917461
- Acronym / sponsor ID
- CURIOSITY / MM-1001-BV
- Conditions
- LRTI, UTI, Gastroenteritis, Systemic Infections/Bacteremia/Meningitis, Fever Without Source
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- MeMed Diagnostics Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Aug 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 an observational prospective study of an in-vitro diagnostic (IVD) assay planned to enroll 632 subjects. The study will be conducted in two stages: Stage A is aimed at identifying individual biomarkers and constructing a multi-parametric diagnostic model, whereas Stage B is aimed at testing the multi-parametric diagnostic model using a fresh cohort of patients.
A collection of clinical, radiological and laboratory data will be gathered in order to establish a final diagnosis. Blood samples will be analyzed and the levels of approximately 700 and 250,000 biomarkers will be determined using immunoassays and molecular measurements respectively.
A final diagnosis will be determined based on a majority decision of a panel of three or more independent physicians. Based on the final diagnosis, the accuracy of individual biomarkers and combined sets of biomarkers for differentiating between distinct groups of patients will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible subjects aged one month of age and older from both genders that attend the hospital or the emergency room (ER) due to a suspected acute infectious disease or due to a non-infectious disease (e.g. Trauma).
Key inclusion criteria (7 listed)
- Patients who are at least one month old and are willing (either the subject or his legal guardian) to sign an informed consent will be eligible for inclusion. For the infectious and non-infectious disease groups, additional inclusion criteria have to be met. These will include:
- Peak fever >37.5°C (99.5°F)
- Clinical suspicion of an acute infectious disease
- Symptoms duration ≤ 12 days
- A non-infectious disease or healthy individuals
Key exclusion criteria (10 listed)
- Patients who will meet one or more of the following criteria will be excluded from the study:
- Evidence of another episode of acute infectious disease in the last two weeks
- Diagnosed congenital immune deficiency (CID)
- Current treatment with immunosuppressive therapy such as: Active chemotherapy,Post-transplant drugs,High dose steroids (>1 mg/kg/day prednisone or equivalent).
- Active radiotherapy
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 a multi-parametric diagnostic assay in differentiating between bacterial and viral etiology in patients with an acute infectious disease
Time frame: 0-10 days after the initiation of symptoms
We will evaluate the sensitivity and specificity of a multi-parametric diagnostic model, incorporating up to five different blood bio-markers in differentiating between bacterial and viral etiology in patients with an acute infectious disease.
2 secondary outcomes
The sensitivity and specificity of individual biomarkers in differentiating between bacterial and viral etiology in patients with an acute infectious disease
Time frame: 0-10 days after the initiation of symptoms
The sensitivity and specificity of a multi-parametric assay in differentiating between mixed (bacterial and viral co-infection) and pure viral infections in patients with an acute infectious disease
Time frame: 0-10 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 LRTI and UTI, 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 7 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: 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 a multi-parametric diagnostic assay in differentiating between bacterial and viral etiology in patients with an acute infectious disease (time frame: 0-10 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.