Skip to content

Safety of Ertapenem in Beta-lactam Allergic Patients.

Cross-reactivity and Tolerability of Ertapenem in Patients With IgE-mediated Allergy to Beta-lactams

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01159379
Enrollment
30
Registered
2010-07-09
Start date
2011-01-31
Completion date
2011-12-31
Last updated
2011-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy, IgE-Mediated Hypersensitivity

Keywords

IgE-mediated allergy, Beta-lactams, Ertapenem, Cross-reactivity, Immediate-type skin tests, Intravenous tolerance tests

Brief 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.

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.

Interventions

DRUGertapenem

intravenous, 1 gram, once

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Catholic University of the Sacred Heart
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Cross-reactivity between beta-lactams and ertapenem.1 day

Secondary

MeasureTime frame
Tolerability of ertapenem in patients with IgE-mediated allergy to beta-lactams.1 day

Countries

Italy

Contacts

Primary ContactDomenico Schiavino, MD
dschiavino@rm.unicatt.it0630155896
Backup ContactAlessandro Buonomo, MD
alessandrobuonomo@hotmail.com0630155896

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026