Safety of Ertapenem in Beta-lactam Allergic Patients.
Information source: Catholic University of the Sacred Heart
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: IgE-Mediated Hypersensitivity; Allergy
Intervention: ertapenem (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Catholic University of the Sacred Heart Official(s) and/or principal investigator(s):
Domenico Schiavino, MD, Principal Investigator, Affiliation: Allergy Department, Catholic University of the Sacred Heart
Overall contact:
Domenico Schiavino, MD, Phone: 0630155896, Ext: +39, Email: dschiavino@rm.unicatt.it
Summary
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.
Clinical Details
Official title: Cross-reactivity and Tolerability of Ertapenem in Patients With IgE-mediated Allergy to Beta-lactams
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Cross-reactivity between beta-lactams and ertapenem.
Secondary outcome: Tolerability of ertapenem in patients with IgE-mediated allergy to beta-lactams.
Detailed description:
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.
Eligibility
Minimum age: 16 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- IgE-mediated allergy to at least one beta-lactam molecule
Exclusion Criteria:
- positive allergy testing to ertapenem
- chronic diseases
- treatment with beta-blockers
- pregnancy
Locations and Contacts
Domenico Schiavino, MD, Phone: 0630155896, Ext: +39, Email: dschiavino@rm.unicatt.it
Allergy Department, Catholic University of the Sacred Heart, Rome 00168, Italy; Not yet recruiting
Domenico Schiavino, MD, Email: dschiavino@rm.unicatt.it
Alessandro Buonomo, MD, Email: alessandrobuonomo@hotmail.com
Domenico Schiavino, Principal Investigator
Additional Information
Starting date: January 2011
Last updated: January 4, 2011
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