Clinical Trials Logo
  1. Home
  2. Allergy
  3. NCT01159379
  4. Details
NCT01159379 Clinical Trial

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
Secondary ID
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

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
See also
  Status Clinical Trial Phase
Terminated NCT02032056 - Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period N/A
Completed NCT01842711 - Cumulative Irritation Patch Test N/A
Completed NCT01633840 - New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges N/A
Completed NCT00997971 - Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein Phase 3
Completed NCT00554983 - Efficacy and Safety From a Recombinant Folding Variant of Bet v 1 Phase 3
Completed NCT00331929 - Respiratory Health Study of Children in Kiryat Tivon N/A
Completed NCT00232518 - Randomised Controlled Clinical Trials of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis N/A
Completed NCT00220753 - Air Cleaners for Children and Adolescents With Asthma and Dog Allergy N/A
Completed NCT04126096 - Negative Predictive Value and NIC of Beta-Lactam Antibiotics. N/A
Completed NCT04046731 - Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation N/A
Completed NCT04004351 - Treatment Modalities in Children and Adolescents Suffering From HDM-induced Allergic Rhinitis and/or Asthma
Not yet recruiting NCT05997784 - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Completed NCT04418999 - Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus Early Phase 1
Completed NCT04186949 - Early Origins of Allergy and Asthma
Completed NCT02127801 - Single Ascending-dose Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Participants Phase 1
Enrolling by invitation NCT05011071 - The Alberta BLOOM Premature Child Study
Not yet recruiting NCT06330974 - Allergy, Asthma, and Atopic Eczema in Finland
Completed NCT02596321 - A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma Phase 3
Completed NCT02306473 - The Leaky Lung Test Early Phase 1
Terminated NCT02601690 - Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America