Bacterial InfectionsNCT03846921
Alpha-defensin as a Diagnostic Means to Distinguish Between Acute Bacterial and Viral Infections
An observational study of Bacterial Infections and Viral Infection, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
This study aims to investigate the use of alpha-defensin as a diagnostic means to distinguish between acute bacterial and viral infections. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Bacterial Infections, Viral Infection
- What is being tested?
- Laboratory blood test
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Mar 2019to Mar 2020
- 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 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with fever attending pediatric emergency department or who have been hospitalized
Who may be able to join
- Children with either bacterial or viral infections
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hillel Yaffe Medical Center
Hadera, 38100
Eias Kassem, MD, eiask@hy.health.gov.il
About this study
This study aims to investigate the use of alpha-defensin as a diagnostic means to distinguish between acute bacterial and viral infections.
- Conditions
- Bacterial Infections, Viral Infection
- Being tested
- Laboratory blood test
- Medical subject headings
- Bacterial Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory blood testDiagnostic test
Laboratory blood test will be analyzed to determine whether there is a rise in alpha-defensin
| Study group | Role | What they receive |
|---|---|---|
| Viral infection | Patients with proven viral infections will have laboratory blood test taken Receives: Diagnostic Test: Laboratory blood test | |
| Bacterial Infection | Patients with proven bacterial infections will have laboratory blood test taken Receives: Diagnostic Test: Laboratory blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rise in alpha-defensin
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start4 Mar 2019
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eias Kassem, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846921
- Sponsor's protocol ID
- HYMC-0003-19
- Status last verified
- Feb 2019
- First submitted
- 18 Feb 2019
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha-defensin as a Diagnostic Means to Distinguish Between Acute Bacterial and Viral Infections
- ClinicalTrials.gov ID
- NCT03846921
- Acronym / sponsor ID
- HYMC-0003-19
- Conditions
- Bacterial Infections, Viral Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the use of alpha-defensin as a diagnostic means to distinguish between acute bacterial and viral infections.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viral infection | – | Diagnostic Test: Laboratory blood testPatients with proven viral infections will have laboratory blood test taken |
| Bacterial Infection | – | Diagnostic Test: Laboratory blood testPatients with proven bacterial infections will have laboratory blood test taken |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with fever attending pediatric emergency department or who have been hospitalized
Key inclusion criteria (1 listed)
- Children with either bacterial or viral infections
Key exclusion criteria (1 listed)
- All others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory blood testLaboratory blood test will be analyzed to determine whether there is a rise in alpha-defensin | Diagnostic test | Bacterial Infection, Viral infection |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eias Kassem, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infections and Viral Infection, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eias Kassem, MD (972-50-6246882, eiask@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rise in alpha-defensin (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2019.