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Assess a Diagnostic Tool to Distinguish Between Bacterial and Viral Infection

NCT01931254 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 777

Last updated 2017-11-28

No results posted yet for this study

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

Sponsors & Collaborators

  • MeMed Diagnostics Ltd.

    collaborator INDUSTRY

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Louis Bont, MD · UMC Utrecht

Eligibility

Min Age
1 Month
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-08-31
Completion
2016-11-30

Countries

  • Israel
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01931254 on ClinicalTrials.gov