Extended Open Challenge in Patients With a History of Drug Eruption Following Beta-lactam Treatment

NCT01520181 | Completed

• 1 other identifier: PEN5
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Beta-lactam Allergy

Outcome Measures

Primary Outcomes (1)

• The safety of a 5-day oral challenge in patients with suspected beta-lactam allergy

  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

Interventions

Beta-lactam oral challenge DRUG

Oral daily dose, according to patient's weight, of amoxicillin or other suspected beta-lactam will be administered for 5 consecutive days

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Arnon Goldberg, Allergy and Clinical Unit, Meir Medical Center

Kfar Saba, 44281, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Allergy and Clinical Immunology Unit, Meir Hospital, Kfar-Saba, Israel

Study Record Dates

• First Submitted: November 20, 2011
• First Posted: January 27, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

IL (1)