Assess a Diagnostic Tool to Distinguish Between Bacterial and Viral Infection

NCT01931254 | Completed

• 1 other identifier: MM-1003-BV
• Study Type: observational
• Target: 777
• Locations: 2 countries
• Sites: 3

Brief 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. 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.

Conditions

Lower Respiratory Tract Infection; Unspecified Fever

Outcome Measures

Primary Outcomes (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.

  one year

Secondary Outcomes (1)

• sensitivity /specificity diagnostic tool

  One year

Other Outcomes (1)

• sensitivity / specificity diagnostic tool

  One year

Eligibility Criteria

• Age: 1 Month - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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)

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• MeMed Diagnostics Ltd.: collaborator

Study Sites (3)

Pediatrics Department, Hillel Yaffe Medical center (HYMC),

Hadera, Israel

Location

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

Haifa, Israel

Location

UMC Utrecht, Wilhelmina Kinderziekenhuis

Utrecht, 3584 EA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

One blood sample and one nasal swab will be collected per patient

Study Officials

• Louis Bont, MD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician-infectiologist

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: August 29, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 28, 2017

Record last verified: 2017-11

Locations

NL (1); IL (2)