Safety of Ertapenem in Beta-lactam Allergic Patients.
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|ClinicalTrials.gov Identifier: NCT01159379|
Recruitment Status : Unknown
Verified January 2010 by Catholic University of the Sacred Heart.
Recruitment status was: Not yet recruiting
First Posted : July 9, 2010
Last Update Posted : January 5, 2011
|Condition or disease||Intervention/treatment||Phase|
|IgE-Mediated Hypersensitivity Allergy||Drug: ertapenem||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cross-reactivity and Tolerability of Ertapenem in Patients With IgE-mediated Allergy to Beta-lactams|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||September 2011|
|Estimated Study Completion Date :||December 2011|
Experimental: ertapenem, tolerance tests
Patients with IgE-mediated allergy to beta-lactams
intravenous, 1 gram, once
Other Name: Invanz
- Cross-reactivity between beta-lactams and ertapenem. [ Time Frame: 1 day ]
- Tolerability of ertapenem in patients with IgE-mediated allergy to beta-lactams. [ Time Frame: 1 day ]
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): 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|