Safety of Ertapenem in Beta-lactam Allergic Patients.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Catholic University of the Sacred Heart.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01159379
First received: June 3, 2010
Last updated: January 4, 2011
Last verified: January 2010
  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

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Cross-reactivity between beta-lactams and ertapenem. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159379

Contacts
Contact: Domenico Schiavino, MD 0630155896 ext +39 dschiavino@rm.unicatt.it
Contact: Alessandro Buonomo, MD 0630155896 ext +39 alessandrobuonomo@hotmail.com

Locations
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         
Sponsors and Collaborators
Catholic University of the Sacred Heart
Merck Sharp & Dohme Corp.
Investigators
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
Beta-Lactams
Ertapenem
Lactams
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014