Penicillin AllergyPhase 4NCT00363688
Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin
A Phase 4 study testing Penicillin test and challenge in people with Penicillin Allergy, run by Meir Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to examine whether oral challenge with penicillin for patients with a known history of non-life threatening allergic reaction to penicillin is well-tolerated irrespective of skin-testing results Read more about this study
- Who is it for?
- Ages 4 to 90 years
- Conditions the study is for
- Penicillin Allergy
- What is being tested?
- Penicillin test and challenge
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Jan 1998to May 2004
- Phase
- Phase 4
- 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 4 to 90 years
- All sexes
- Child, Adult, Older adult
Inclusion Criteria:patients with a history of non-life threatening allergic reaction to penicillin, dating back at least 3 years -
Exclusion Criteria:Patients who had a life-threatening anaphylactic reaction to penicillin consisting of unconsciousness or anaphylaxis requiring life-resuscitation and those who had non-IgE mediated hypersensitivity reactions
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin: Is It Safe?
The purpose of this study is to examine whether oral challenge with penicillin for patients with a known history of non-life threatening allergic reaction to penicillin is well-tolerated irrespective of skin-testing results
Read the detailed description
Objective: To examine whether oral challenge with penicillin for patients with a known history of non-life threatening allergic reaction to penicillin is well-tolerated irrespective of skin-testing results long after the event occurred.
Methods: In this prospective, open-label, controlled, multi-clinical trial, 8702 individuals from primary care clinics were screened for penicillin allergy. 169 patients with a history of non-life threatening allergic reaction to penicillin, dating back at least 3 years, were recruited for study. Regardless of the response to penicillin skin testing, patients received the recommended daily dosage of penicillin and amoxicillin on two separate occasions. 2-6 years later a follow-up was conducted to assess the outcomes of further penicillin administration.
Results: 92.9% of the patients had an allergic reaction 6 years or longer before enrollment in the study. Of 272 challenges, 137 were skin-test positive with mild rash in 9 patients (6.6%), and 135 were skin-test negative with similar allergic reaction in 5 (3.7%) (P =.29). At follow-up, 3 of 55 patients (5.5%) who were given a full treatment course of penicillin developed mild skin eruption.
Conclusions: A positive penicillin skin testing of patients with a history of non-life threatening allergic reaction to penicillin occurring 3 years or longer from the event was not associated with a greater prevalence of adverse reactions to oral challenge with penicillin than a negative one. It is of importance to determine whether oral challenge can serve as a diagnostic procedure for this particular group of patients, thereby saving the need for prior penicillin skin testing.
- Conditions
- Penicillin Allergy
- Being tested
- Penicillin test and challenge
- Keywords
- Non life threatening allergic reaction, oral challenge, penicillin, skin testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penicillin test and challengeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
results of an oral challenge with penicillin (penicillin V) and amoxicillin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startJan 1998
- Study completionMay 2004
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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Arnon Goldberg, MD, Principal investigator, Allergy and Clinical Immunology Unit, Meir Medical Center, Kfar Saba, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363688
- Sponsor's protocol ID
- 756497
- Status last verified
- Dec 1997
- First submitted
- 10 Aug 2006
- Last updated
- 15 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin: Is It Safe?
- ClinicalTrials.gov ID
- NCT00363688
- Acronym / sponsor ID
- 756497
- Conditions
- Penicillin Allergy
- Keywords
- Non life threatening allergic reaction, oral challenge, penicillin, skin testing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 1998
- Study completion
- May 2004
- First posted
- 15 Aug 2006 (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 purpose of this study is to examine whether oral challenge with penicillin for patients with a known history of non-life threatening allergic reaction to penicillin is well-tolerated irrespective of skin-testing results
Detailed description
Objective: To examine whether oral challenge with penicillin for patients with a known history of non-life threatening allergic reaction to penicillin is well-tolerated irrespective of skin-testing results long after the event occurred.
Methods: In this prospective, open-label, controlled, multi-clinical trial, 8702 individuals from primary care clinics were screened for penicillin allergy. 169 patients with a history of non-life threatening allergic reaction to penicillin, dating back at least 3 years, were recruited for study. Regardless of the response to penicillin skin testing, patients received the recommended daily dosage of penicillin and amoxicillin on two separate occasions. 2-6 years later a follow-up was conducted to assess the outcomes of further penicillin administration.
Results: 92.9% of the patients had an allergic reaction 6 years or longer before enrollment in the study. Of 272 challenges, 137 were skin-test positive with mild rash in 9 patients (6.6%), and 135 were skin-test negative with similar allergic reaction in 5 (3.7%) (P =.29). At follow-up, 3 of 55 patients (5.5%) who were given a full treatment course of penicillin developed mild skin eruption.
Conclusions: A positive penicillin skin testing of patients with a history of non-life threatening allergic reaction to penicillin occurring 3 years or longer from the event was not associated with a greater prevalence of adverse reactions to oral challenge with penicillin than a negative one. It is of importance to determine whether oral challenge can serve as a diagnostic procedure for this particular group of patients, thereby saving the need for prior penicillin skin testing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
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 test and challenge | Drug | – |
Primary outcome
results of an oral challenge with penicillin (penicillin V) and amoxicillin
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2006.
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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.
Arnon Goldberg, MD principal investigator
Allergy and Clinical Immunology Unit, Meir Medical Center, Kfar Saba, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Penicillin test and challenge in people with Penicillin Allergy, run by Meir 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?
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: stopped early, as of the sponsor's last update on 15 Aug 2006. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
results of an oral challenge with penicillin (penicillin V) and amoxicillin. 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 15 Aug 2006.