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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


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


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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