Safety of Ertapenem in Beta-lactam Allergic Patients.
Recruitment status was Not yet recruiting
The purpose of this study is to assess cross-reactivity and tolerability of ertapenem in patients with IgE-mediated allergy to at least one beta-lactam molecule.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Cross-reactivity and Tolerability of Ertapenem in Patients With IgE-mediated Allergy to Beta-lactams|
- Cross-reactivity between beta-lactams and ertapenem. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
- Tolerability of ertapenem in patients with IgE-mediated allergy to beta-lactams. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: ertapenem, tolerance tests
Patients with IgE-mediated allergy to beta-lactams
intravenous, 1 gram, once
Other Name: Invanz
Ertapenem is a new carbapenem, stable to dehydropeptidase which has a broad antibacterial activity. Ertapenem exhibits a bactericidal mode of action and it has a long half-life of 4.5 hours; for this reason it can be developed as a single daily dose carbapenem.
In literature, no cases of IgE-mediated allergy to ertapenem have been described until now. However, a single study put in evidence a 47% rate of cross-reactivity between imipenem-cilastatin and beta-lactams in a group of patients affected by IgE-mediated allergy to these drugs. For this reason carbapenem administration to beta-lactam allergic patients has always been considered potentially harmful. Other studies reported lower cross-reactivity rates (from 7 to 11%) between imipenem-cilastatin and beta-lactams but patients of these studies did not undergo any allergy testing in order to demonstrate the pathogenesis of the reactions.
Recent studies put in evidence that imipenem has a very low cross-reactivity rate with other beta-lactams and they have a very good tolerability among patients with IgE-mediated allergy to beta-lactams: Romano et al. found a cross-reactivity rate of 0.9% between imipenem and penicillins in 112 penicillin-allergic patients (mean age 44.56 ± 15.66 ys.); Atanasković-Marković et al. found a cross-reactivity rate of 0.8% in 124 paediatric patients (age range 3-14 ys.) between imipenem and penicillins. In both groups imipenem was well tolerated by patients with negative allergy testing.
Meropenem showed to have a good tolerability too in penicillin allergic patients: Romano et al. found a cross-reactivity rate of 0.9% between penicillins and meropenem in penicillin-allergic patients (mean age 47.83 ± 15.8); Atanasković-Marković et al. found a cross-reactivity rate of 0.8% in 109 paediatric patients (age range 3-14 ys.) between meropenem and penicillins. In both groups meropenem was well tolerated by patients with negative allergy testing.
No data regarding the cross-reactivity of ertapenem with other beta-lactams and its tolerability among patients with IgE-mediated allergy beta-lactams are available in literature.
Aim of the study On the basis of those data, we decided to investigate the cross-reactivity of ertapenem with other beta-lactams in patients suffering from IgE-mediated allergy to at least one beta-lactam molecule and its tolerability in a group of a patients with negative allergy testing with ertapenem.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159379
|Contact: Domenico Schiavino, MD||0630155896 ext +firstname.lastname@example.org|
|Contact: Alessandro Buonomo, MD||0630155896 ext +email@example.com|
|Allergy Department, Catholic University of the Sacred Heart||Not yet recruiting|
|Rome, Italy, 00168|
|Contact: Domenico Schiavino, MD firstname.lastname@example.org|
|Contact: Alessandro Buonomo, MD email@example.com|
|Principal Investigator: Domenico Schiavino|
|Principal Investigator:||Domenico Schiavino, MD||Allergy Department, Catholic University of the Sacred Heart|