Study Results
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Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2011-01-31
2011-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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ertapenem, tolerance tests
Patients with IgE-mediated allergy to beta-lactams
ertapenem
intravenous, 1 gram, once
Interventions
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ertapenem
intravenous, 1 gram, once
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* chronic diseases
* treatment with beta-blockers
* pregnancy
16 Years
75 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Catholic University of the Sacred Heart
OTHER
Responsible Party
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Catholic University of the Sacred Heart
Principal Investigators
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Domenico Schiavino, MD
Role: PRINCIPAL_INVESTIGATOR
Allergy Department, Catholic University of the Sacred Heart
Locations
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Allergy Department, Catholic University of the Sacred Heart
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1131/09
Identifier Type: -
Identifier Source: org_study_id
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