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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01520181
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : October 7, 2015
Information provided by (Responsible Party):
Arnon Goldberg, Meir Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Beta-lactam Allergy Drug: Beta-lactam oral challenge Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : March 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01520181

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Arnon Goldberg, Allergy and Clinical Unit, Meir Medical Center
Kfar-Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center
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Responsible Party: Arnon Goldberg, Head, Allergy and Clinical Immunology Unit, Meir Hospital, Kfar-Saba, Israel, Meir Medical Center Identifier: NCT01520181    
Other Study ID Numbers: PEN5
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents