Extended Open Challenge in Patients With a History of Drug Eruption Following Beta-lactam Treatment
This study is currently recruiting participants.
Verified September 2012 by Meir Medical Center
Sponsor:
Meir Medical Center
Information provided by (Responsible Party):
Arnon Goldberg, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01520181
First received: November 20, 2011
Last updated: September 19, 2012
Last verified: September 2012
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Purpose
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
Eligibility| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520181
Contacts
| Contact: Arnon Goldberg, MD | 972-9-7472717 | arnong@clalit.org.il |
Locations
| Israel | |
| Arnon Goldberg, Allergy and Clinical Unit, Meir Medical Center | Recruiting |
| Kfar-Saba, Israel, 44281 | |
| Contact: Arnon Goldberg, M.D. 972-9-7472717 arnong@clalit.org.il | |
| 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 |
| ClinicalTrials.gov 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:
|
Lactams Beta-Lactams Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013