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Alpha-defensin as a Diagnostic Means to Distinguish Between Acute Bacterial and Viral Infections

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ClinicalTrials.gov Identifier: NCT03846921
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief Summary:
This study aims to investigate the use of alpha-defensin as a diagnostic means to distinguish between acute bacterial and viral infections.

Condition or disease Intervention/treatment
Bacterial Infections Viral Infection Diagnostic Test: Laboratory blood test

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Alpha-defensin as a Diagnostic Means to Distinguish Between Acute Bacterial and Viral Infections
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Viral infection
Patients with proven viral infections will have laboratory blood test taken
Diagnostic Test: Laboratory blood test
Laboratory blood test will be analyzed to determine whether there is a rise in alpha-defensin

Bacterial Infection
Patients with proven bacterial infections will have laboratory blood test taken
Diagnostic Test: Laboratory blood test
Laboratory blood test will be analyzed to determine whether there is a rise in alpha-defensin




Primary Outcome Measures :
  1. Rise in alpha-defensin [ Time Frame: One year ]
    Laboratory blood tests will be analyzed to determine whether there is a rise in alpha-defensin levels in bacterial infections as compared to viral infections.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with fever attending pediatric emergency department or who have been hospitalized
Criteria

Inclusion Criteria:

  • Children with either bacterial or viral infections

Exclusion Criteria:

  • All others

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846921


Contacts
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Contact: Eias Kassem, MD 972-50-6246882 eiask@hy.health.gov.il

Locations
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Israel
Hillel Yaffe Medical Center Recruiting
Hadera, Israel, 38100
Contact: Eias Kassem, MD       eiask@hy.health.gov.il   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Eias Kassem, MD Hillel Yaffe Medical Center

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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03846921     History of Changes
Other Study ID Numbers: HYMC-0003-19
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Virus Diseases
Defensins
alpha-Defensins
Anti-Infective Agents