We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT01520181
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Beta-lactam Allergy Drug: Beta-lactam oral challenge

Study Design

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT01520181


Locations
Israel
Arnon Goldberg, Allergy and Clinical Unit, Meir Medical Center
Kfar-Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center
More Information

Responsible Party: Arnon Goldberg, Head, Allergy and Clinical Immunology Unit, Meir Hospital, Kfar-Saba, Israel, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01520181     History of Changes
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:
Lactams
beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents