Penicillin AllergyNCT03499457
Penicillin Allergy in Shfayim Clinic
A study testing Amoxicillin in people with Penicillin Allergy, run by Clalit Health Services.
Trial summary
revising penicillin allergy in the medical records, by taking full medical history and giving a challange test, in order to imrove the medical records and treatment possibilities. Read more about this study
- Who is it for?
- Ages 5 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Penicillin Allergy
- What is being tested?
- Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Jun 2019
- 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 5 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- penicillin allergy in the medical record
Who cannot join
- pregnancy lack of informed consent
Trial locations and contacts
No sites are listed yet.
About this study
revising penicillin allergy in the medical records, by taking full medical history and giving a challange test, in order to imrove the medical records and treatment possibilities.
Read the detailed description
issuing a list of patients with a title of penicillin allergy in their medical record. inviting these patients to an appointmnet with their family physician, in which a specific history will be take to evaluate the quality of the allergy.
patients with suscpition of a life threatening allergic reaction will be reffered to an allergy clinic for the challange test. the rest of the pateints will be given the test in the primary clinic: 1ml (50 grams) of amoxicillin, and an hour later a full dose of 500 mg amoxicillin.
after determining no allergic reaction develops the title will be erased from the medical record.
- Conditions
- Penicillin Allergy
- Being tested
- Amoxicillin
- Keywords
- Penicillin Allergy, chalenge test, primary clinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
chalange test of 50 mg, and after an hour 500 mg
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | penicillin chalange test, as descibed. Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
immidiate urticarial reaction
shortness of breath, angioedema
Measured: with 2 hours of test
Secondary outcomes (1)
rash
body rash or itch seen by patient or physician
Measured: with 2 hours of test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study startJun 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJun 2019 (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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lital Goldberg, Clalit Health Services
- Investigators
- lital f goldberg, MD. MPH, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499457
- Sponsor's protocol ID
- 0185-17-COM2
- Status last verified
- Apr 2018
- First submitted
- 8 Apr 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penicillin Allergy in Shfayim Clinic
- ClinicalTrials.gov ID
- NCT03499457
- Acronym / sponsor ID
- 0185-17-COM2
- Conditions
- Penicillin Allergy
- Keywords
- Penicillin Allergy, chalenge test, primary clinic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 17 Apr 2018 (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.
revising penicillin allergy in the medical records, by taking full medical history and giving a challange test, in order to imrove the medical records and treatment possibilities.
Detailed description
issuing a list of patients with a title of penicillin allergy in their medical record. inviting these patients to an appointmnet with their family physician, in which a specific history will be take to evaluate the quality of the allergy.
patients with suscpition of a life threatening allergic reaction will be reffered to an allergy clinic for the challange test. the rest of the pateints will be given the test in the primary clinic: 1ml (50 grams) of amoxicillin, and an hour later a full dose of 500 mg amoxicillin.
after determining no allergic reaction develops the title will be erased from the medical record.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: Amoxicillinpenicillin chalange test, as descibed. |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- penicillin allergy in the medical record
Key exclusion criteria (1 listed)
- pregnancy lack of informed consent
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 |
|---|---|---|
| Amoxicillinchalange test of 50 mg, and after an hour 500 mg | Drug | treatment |
Primary outcome
immidiate urticarial reaction
Time frame: with 2 hours of test
shortness of breath, angioedema
1 secondary outcome
rash
Time frame: with 2 hours of test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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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.
lital f goldberg, MD. MPH principal investigator
Clalit Health Services
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin in people with Penicillin Allergy, run by Clalit Health Services.
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 17 Apr 2018. 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 lital f goldberg, MD. MPH. (972544248284, litalmargalith@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immidiate urticarial reaction (time frame: with 2 hours of test). 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 17 Apr 2018.