Extended Open Challenge in Patients With a History of Drug Eruption Following Beta-lactam Treatment
Information source: Meir Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Beta-lactam Allergy
Intervention: Beta-lactam oral challenge (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Meir Medical Center Overall contact:
Arnon Goldberg, MD, Phone: 972-9-7472717, Email: arnong@clalit.org.il
Summary
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.
Clinical Details
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: The safety of a 5-day oral challenge in patients with suspected beta-lactam allergy
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Arnon Goldberg, MD, Phone: 972-9-7472717, Email: arnong@clalit.org.il
Arnon Goldberg, Allergy and Clinical Unit, Meir Medical Center, Kfar-Saba 44281, Israel; Recruiting
Arnon Goldberg, M.D., Phone: 972-9-7472717, Email: arnong@clalit.org.il
Arnon Goldberg, M.D., Principal Investigator
Additional Information
Starting date: March 2012
Last updated: September 19, 2012
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