Safety of Ertapenem in Beta-lactam Allergic Patients.

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01159379
• Other study ID #: 1131/09
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 3, 2010
• Last updated: January 4, 2011
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2010
• Source: Catholic University of the Sacred Heart
• Contact: Domenico Schiavino, MD
• Phone: 0630155896
• Email: dschiavino[@]rm.unicatt.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Allergy
• Hypersensitivity
• Hypersensitivity, Immediate
• IgE-Mediated Hypersensitivity

Intervention

Drug:
• ertapenem
intravenous, 1 gram, once

Locations

Country	Name	City	State
Italy	Allergy Department, Catholic University of the Sacred Heart	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cross-reactivity between beta-lactams and ertapenem.		1 day	Yes
Secondary	Tolerability of ertapenem in patients with IgE-mediated allergy to beta-lactams.		1 day	Yes