- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01520181
Extended Open Challenge in Patients With a History of Drug Eruption Following Beta-lactam Treatment
October 6, 2015 updated by: Arnon Goldberg, Meir Medical Center
Beta-lactam allergy is the most prevalent drug allergy.
Drug eruption is the most common symptom whereas life-threatening anaphylaxis is rather rare.
A recently published study (Journal of Allergy and Clinical Immunology, January 2011, Vol.
127, p. 218-222) described the safety of a 2-day oral beta-lactam challenge in penicillin-allergic patients, disregarding their penicillin skin test results.
In the proposed study the investigators will similarly challenge beta-lactam allergic patients, both children and adults for an extended (5 days) period of time.
The study will include patients with a history of a skin rash following beta-lactam administration as well as patients who cannot provide any data on their presumed allergic reaction, disregarding their penicillin skin test results.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
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
-
-
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Kfar-Saba, Israel, 44281
- Arnon Goldberg, Allergy and Clinical Unit, Meir Medical Center
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- History of skin rash following the administration of beta-lactam antibiotic
- Patients with a diagnosis of penicillin allergy who have no data on the nature of the symptoms that have eventually resulted in establishing this diagnosis
Exclusion Criteria:
- Patients in whom the rash appeared within 1 hour after the last dose of the drug
- Patients who also developed other anaphylactic symptoms
- Patients who had a life-threatening rash such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis or DRESS.
- Pregnancy
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The safety of a 5-day oral challenge in patients with suspected beta-lactam allergy
Time Frame: 5 days
|
In case of the development of any adverse reactions throughout the 5-day challenge patients will notify the investigators over the phone.
If assessed necessary by the investigators, patients will return to the Allergy Clinic for repeated evaluation.
After completion of the 5-day challenge all patients will be contacted by the investigators and will be inquired about any adverse reactions throughout the challenge.
The number of participants with adverse reactions to the challenge will be reported.
|
5 days
|
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
March 1, 2012
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
November 20, 2011
First Submitted That Met QC Criteria
January 26, 2012
First Posted (Estimate)
January 27, 2012
Study Record Updates
Last Update Posted (Estimate)
October 7, 2015
Last Update Submitted That Met QC Criteria
October 6, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEN5
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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