Penicillin AllergyNCT02702349
The Frequency of Positive Challenge Test to Penicillin in Children Suspected to Have Allergy to Penicillin
A study testing penicillin test in people with Penicillin Allergy, run by Hillel Yaffe Medical Center.
Trial summary
The incidence of reactions during penicillin challenge tests among children with suspected penicillin allergy Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Penicillin Allergy
- What is being tested?
- penicillin test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Feb 2017
- Phase
- Interventional
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children older then 6 month with suspected penicillin allergy
Who cannot join
- Children under 6 month old
Trial locations and contacts
No sites are listed yet.
About this study
The incidence of reactions during penicillin challenge tests among children with suspected penicillin allergy
Read the detailed description
children who are suspected to have penicillin allergy due to a suspected allergic reaction during penicillin treatment are sent for allergy investigation to role out allergy. Patients go through penicillin test and if negative are challenged by oral administration under medical observation. The investigators would like to check the incidence among our pediatric pediatric patients.
- Conditions
- Penicillin Allergy
- Being tested
- penicillin test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
penicillin testOther
children are tested for penicillin allergy and then challenged with penicillin P.O.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | penicillin test and challenge Receives: Other: penicillin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of reactions during penicillin challenge tests among children with suspected penicillin allergy
To find out how many children are actually true allergic to penicillin
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 posted8 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penicillin AllergyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- vered schichter- konfino, MD, Principal investigator, Hillelyaffe medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702349
- Sponsor's protocol ID
- 52-15
- Status last verified
- Feb 2016
- First submitted
- 3 Mar 2016
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Frequency of Positive Challenge Test to Penicillin in Children Suspected to Have Allergy to Penicillin
- ClinicalTrials.gov ID
- NCT02702349
- Acronym / sponsor ID
- 52-15
- Conditions
- Penicillin Allergy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Apr 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 8 Mar 2016 (estimated)
- 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.
The incidence of reactions during penicillin challenge tests among children with suspected penicillin allergy
Detailed description
children who are suspected to have penicillin allergy due to a suspected allergic reaction during penicillin treatment are sent for allergy investigation to role out allergy. Patients go through penicillin test and if negative are challenged by oral administration under medical observation. The investigators would like to check the incidence among our pediatric pediatric patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: penicillin testpenicillin test and challenge |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children older then 6 month with suspected penicillin allergy
Key exclusion criteria (1 listed)
- Children under 6 month old
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 |
|---|---|---|
| penicillin testchildren are tested for penicillin allergy and then challenged with penicillin P.O. | Other | 1 |
Primary outcome
The incidence of reactions during penicillin challenge tests among children with suspected penicillin allergy
Time frame: one year
To find out how many children are actually true allergic to penicillin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- 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.
vered schichter- konfino, MD principal investigator
Hillelyaffe medical center
Questions about this trial
What is this clinical trial studying?
A study testing penicillin test in people with Penicillin Allergy, run by Hillel Yaffe Medical Center.
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 2016. Status can change between updates, so confirm with the study contact before making plans.
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 IRIS DAHAN, MSc (00972546620184, IRIS2204@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of reactions during penicillin challenge tests among children with suspected penicillin allergy (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 2016.