Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Arnon Goldberg, Meir Medical Center Identifier:
First received: November 20, 2011
Last updated: September 19, 2012
Last verified: September 2012

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.

Condition Intervention
Beta-lactam Allergy
Drug: Beta-lactam oral challenge

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

Resource links provided by NLM:

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • The safety of a 5-day oral challenge in patients with suspected beta-lactam allergy [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    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.

Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01520181

Contact: Arnon Goldberg, MD 972-9-7472717

Arnon Goldberg, Allergy and Clinical Unit, Meir Medical Center Recruiting
Kfar-Saba, Israel, 44281
Contact: Arnon Goldberg, M.D.    972-9-7472717   
Principal Investigator: Arnon Goldberg, M.D.         
Sponsors and Collaborators
Meir Medical Center
  More Information

No publications provided

Responsible Party: Arnon Goldberg, Head, Allergy and Clinical Immunology Unit, Meir Hospital, Kfar-Saba, Israel, Meir Medical Center Identifier: NCT01520181     History of Changes
Other Study ID Numbers: PEN5
Study First Received: November 20, 2011
Last Updated: September 19, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses processed this record on March 01, 2015