AzTrials
AzTrials

Lower Respiratory Tract InfectionOPPORTUNITYNCT01931254

Assess a Diagnostic Tool to Distinguish Between Bacterial and Viral Infection

An observational study of Lower Respiratory Tract Infection and Unspecified Fever, run by UMC Utrecht at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In the past 70 years antibiotics have served as the first line of defense against infectious diseases. However, antibiotics are only effective against bacterial infections and are not the solution for infections caused by viruses such as common colds or flu. Read more about this study

Who is it for?
Ages 1 month to 60 months
How many people
777 participants
Where
3 sitesin 2 countries
Study dates
Oct 2013to Nov 2016
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 60 months
  • All sexes
  • No healthy volunteers
  • Child

Study population: The study population will include eligible subjects aged 1 to 60 months of age from both genders that attend the hospital or the emergency department (ED) due to a suspected LRTI, FWS or due to a non-infectious disease. These subjects 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 an undetermined disease etiology 5. Patients with a non-infectious disease (control group; n=140) We estimate that approximately 75% of the patients will fall into categories number 1-3 (i.e., bacterial, viral or mixed infections).

Who may be able to join

  • Patients aged 1 to 60 months whose their legal guardian agrees to sign an informed consent will be eligible for inclusion.
  • The infectious disease group (n = 690) should also fulfill the following criteria:
  • Peak temperature ≥ 38°C (100.4°F) (AND)
  • Symptoms duration ≤ 6 days (AND)
  • Clinical suspicion of LRTI (OR)
  • Fever without a clear source where no localizing sign of infection are present at the emergency department
  • The non-infectious disease control group will include:
  • Patients with a non-infectious disease (n = 140)

Who cannot join

  • Patients who will meet one or more of the following criteria will be excluded from the study:
  • Another episode of febrile infection during the past 3 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
  • Current treatment with immune-suppressive or immune-modulating therapies including without limitations:
Show all 17Show fewer
  • Use of high dose steroids >1 mg/kg/day prednisone or equivalent in the past two weeks
  • Monoclonal antibody administration
  • Intravenous immunoglobulin (IVIG)
  • Cyclosporine
  • G/GM-CSF
  • Anti-TNF agents
  • Interferon (of all kinds)
  • Other severe illnesses that affect life expectancy and quality of life such as:
  • Moderate to severe psychomotor retardation
  • Thalassemia Major
  • Moderate to severe congenital metabolic disorder

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Israel2 sites

  • Pediatrics Department, Hillel Yaffe Medical center (HYMC),

    Hadera

  • Pediatric Emergency Department (ED), Bnei Zion Medical Center (BZMC),

    Haifa

Other trials in Israel

Netherlands1 site

  • UMC Utrecht, Wilhelmina Kinderziekenhuis

    Utrecht, 3584 EA

Other trials in Netherlands

About this study

Official title: Prospective, Blinded Validation Study to Assess Accuracy of a Diagnostics for Distinguishing Between Bacterial and Viral Etiology in Pediatric Patients With Lower Respiratory Tract Infections and Fever Without Source

In the past 70 years antibiotics have served as the first line of defense against infectious diseases. However, antibiotics are only effective against bacterial infections and are not the solution for infections caused by viruses such as common colds or flu. Despite their contribution to healthcare, antibiotics are currently recognized as the most misused drugs in the world with global overuse estimated at 40%-70%, mostly due to the ineffectiveness of current diagnostic solutions to distinguish between bacterial and viral infections. Antibiotics misuse often causes preventable adverse events that impact patient care and lead to the emergence of antibiotic-resistant bacteria, one of the major threats to global health today. To address these challenges, MeMed has been developing the ImmunoDx™, a novel technology that relies on the best available detection system for differentiating between viruses and bacteria - the body's own immune system. The ImmunoDx™ technology employs a simple blood test that provides the physician, within two-hours, the information he needs to decide whether to treat the patient with antibiotics or not. This technology has been tested on over 1000 patients of different ages and diseases and was found to be highly accurate and safe. The current study is a non-interventional study and the participants do not receive any investigational drug nor any experimental examination or procedure. Therefore, the collected data in this study will not affect the diagnosis, prognosis, or treatment of the participants. Participation includes the collection of a teaspoon of blood and collection of a specimen using a nasal swab. These procedures are common in the clinical practice and are widely performed and possess no significant risk. By participating in the study, the subjects impact the development of the ImmunoDx™ technology, which is expected to enable a future faster and more accurate diagnosis of infectious diseases as well as more appropriate prescription of antibiotics. This will open the way to improve treatment decisions in millions of patients around the world.

Read the detailed description

This is a prospective clinical validation study of a novel in-vitro diagnostic (IVD) assay that will enroll 830 pediatric patients. The study will be conducted in two stages: In stage A 50 patients will be enrolled with the aim of verifying proper protocol execution including proper collection of patient samples, accurate data retrieval and precise etiology determination. In stage B 780 patients will be enrolled with the aim of blinded validation of the host-response based diagnostics using a fresh independent cohort of patients. Patients enrolling into the study will be managed according to the current standard of care (GCP) and per standard institutional procedures. Participation in this study requires the collection of an additional blood sample and a nasal swab sampling.

The investigated assay requires the measurement of three host-related, blood-based, protein biomarkers that are being integrated using a logistic regression formula into a single score. Based on this score, each patient is classified into one of three categories: (i) bacterial immune response (i.e., pure bacterial infections and mixed bacterial and viral co-infection), (ii) viral immune response, and (iii) marginal immune response (inconclusive or non-infectious). It is estimated that 10-20% of the infected patients will have a marginal immune response. A composite reference standard will be used in order to determine the diagnosis of each patient. Specifically, all the clinical, radiological, microbiological and laboratory data of each patient, will be recorded in a dedicated eCRF. Based on this data, the diagnosis of each patient will be determined by a panel of three independent pediatricians. Each pediatrician will be blinded to the diagnosis of his peers and to the assay results. In the current study, unanimous agreement between the experts ("consensus agreement") will be considered as the true diagnosis for the purpose of computing the assay performance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sensitivity / specificity diagnostic tool

    To determine the sensitivity and specificity of a host-response based diagnostics in differentiating between bacterial and viral etiology of pediatric patients aged 2 to 60 months with LRTI or FWS.

    Measured: one year

Secondary outcomes (1)

  1. sensitivity /specificity diagnostic tool

    To determine the sensitivity and specificity of a host-response based diagnostics in differentiating between infectious and non-infectious disease of pediatric patients aged 2 to 60 months.

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionAug 2016
  4. Study completionNov 2016

Resources

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
Case-control
Time perspective
Prospective
Enrolment
777 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01931254
Sponsor's protocol ID
MM-1003-BV
Acronym
OPPORTUNITY
Status last verified
Nov 2017
First submitted
22 Aug 2013
Last updated
28 Nov 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lower Respiratory Tract Infection and Unspecified Fever, run by UMC Utrecht at 3 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 8 inclusion and 17 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 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Israel, Netherlands. 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?

sensitivity / specificity diagnostic tool (time frame: one year). 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 NCT01931254.

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 28 Nov 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in