NCT01520181

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Beta-lactam oral challenge	Oral daily dose, according to patient's weight, of amoxicillin or other suspected beta-lactam will be administered for 5 consecutive days

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-01-27
• Last updated: 2015-10-07

Locations

1 site across 1 country: Israel