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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:
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
History of Changes

November 20, 2011
September 19, 2012
March 2012
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01520181 on ClinicalTrials.gov Archive Site
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Extended Open Challenge in Patients With a History of Drug Eruption Following Beta-lactam Treatment
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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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Interventional
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Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Beta-lactam Allergy
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
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December 2012   (final data collection date for primary outcome measure)

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
Both
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Yes
Contact: Arnon Goldberg, MD 972-9-7472717 arnong@clalit.org.il
Israel
 
NCT01520181
PEN5
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Arnon Goldberg, Meir Medical Center
Meir Medical Center
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Meir Medical Center
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP