- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03846921
Alpha-defensin as a Diagnostic Means to Distinguish Between Acute Bacterial and Viral Infections
March 6, 2019 updated by: Hillel Yaffe Medical Center
This study aims to investigate the use of alpha-defensin as a diagnostic means to distinguish between acute bacterial and viral infections.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hadera, Israel, 38100
- Recruiting
- Hillel Yaffe Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children with fever attending pediatric emergency department or who have been hospitalized
Description
Inclusion Criteria:
- Children with either bacterial or viral infections
Exclusion Criteria:
- All others
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Viral infection
Patients with proven viral infections will have laboratory blood test taken
|
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
|
Laboratory blood test will be analyzed to determine whether there is a rise in alpha-defensin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 4, 2019
Primary Completion (ANTICIPATED)
March 1, 2020
Study Completion (ANTICIPATED)
March 1, 2020
Study Registration Dates
First Submitted
February 18, 2019
First Submitted That Met QC Criteria
February 18, 2019
First Posted (ACTUAL)
February 20, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 8, 2019
Last Update Submitted That Met QC Criteria
March 6, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYMC-0003-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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