Safety of Ertapenem in Beta-lactam Allergic Patients.
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
IgE-Mediated Hypersensitivity Allergy |
Drug: ertapenem |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Cross-reactivity and Tolerability of Ertapenem in Patients With IgE-mediated Allergy to Beta-lactams |
- Cross-reactivity between beta-lactams and ertapenem. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
- Tolerability of ertapenem in patients with IgE-mediated allergy to beta-lactams. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ertapenem, tolerance tests
Patients with IgE-mediated allergy to beta-lactams
|
Drug: ertapenem
intravenous, 1 gram, once
Other Name: Invanz
|
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| Ages Eligible for Study: | 16 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Domenico Schiavino, MD | 0630155896 ext +39 | dschiavino@rm.unicatt.it |
| Contact: Alessandro Buonomo, MD | 0630155896 ext +39 | alessandrobuonomo@hotmail.com |
| Italy | |
| Allergy Department, Catholic University of the Sacred Heart | Not yet recruiting |
| Rome, Italy, 00168 | |
| Contact: Domenico Schiavino, MD dschiavino@rm.unicatt.it | |
| Contact: Alessandro Buonomo, MD alessandrobuonomo@hotmail.com | |
| Principal Investigator: Domenico Schiavino | |
| Principal Investigator: | Domenico Schiavino, MD | Allergy Department, Catholic University of the Sacred Heart |
More Information
No publications provided
| Responsible Party: | Prof. Domenico Schiavino, Catholic University of the Sacred Heart |
| ClinicalTrials.gov Identifier: | NCT01159379 History of Changes |
| Other Study ID Numbers: | 1131/09 |
| Study First Received: | June 3, 2010 |
| Last Updated: | January 4, 2011 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Catholic University of the Sacred Heart:
|
IgE-mediated allergy Beta-lactams Ertapenem |
Cross-reactivity Immediate-type skin tests Intravenous tolerance tests |
Additional relevant MeSH terms:
|
Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lactams Beta-Lactams |
Ertapenem Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013