Completed

NCT Number: NCT01520181

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

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.

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Key information

Conditions

Beta-lactam Allergy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arnon Goldberg, Allergy and Clinical Unit, Meir Medical Center

Kfar Saba, 44281, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

Time frame: 5 days

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.

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Jan 27, 2012
Registry last updated: Oct 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.