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

Beta-lactam Allergy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01520181
• Other study ID #: PEN5
• Status: Completed
• Phase: N/A
• First received: November 20, 2011
• Last updated: October 6, 2015
• Start date: March 2012
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Beta-lactam Allergy

Intervention

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

Locations

Country	Name	City	State
Israel	Arnon Goldberg, Allergy and Clinical Unit, Meir Medical Center	Kfar-Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes