Beta-lactam Allergy | Extended Open Challenge in Patients With a History of Drug Eruption Following Beta-lactam Treatment
Beta-lactam Allergy research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Beta-lactam oral challengeOral daily dose, according to patient's weight, of amoxicillin or other suspected beta-lactam will be administered for 5 consecutive days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: March 2012
Completed Date: June 2015
Primary Outcome: The safety of a 5-day oral challenge in patients with suspected beta-lactam allergy
Study sponsors, principal investigator, and references
Lead Sponsor: Meir Medical Center