## Protocol Section
### Identification Module
**NCT ID:** NCT01159379

**Brief Title:** Safety of Ertapenem in Beta-lactam Allergic Patients.

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

#### Organization Study ID Info
**ID:** 1131/09
#### Organization
**Class:** OTHER
**Full Name:** Catholic University of the Sacred Heart
### Status Module
#### Completion Date
**Date:** 2011-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2011-01-05

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-01-04

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2011-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2011-01

**Status Verified Date:** 2010-01

#### Study First Post Date
**Date:** 2010-07-09
**Type:** ESTIMATED
**Study First Submit Date:** 2010-06-03
**Study First Submit QC Date:** 2010-07-08
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

#### Lead Sponsor

**Class:** OTHER

**Name:** Catholic University of the Sacred Heart

#### Responsible Party

**Old Name Title:** Prof. Domenico Schiavino

**Old Organization:** Catholic University of the Sacred Heart

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief 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.

**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.

### Conditions Module

**Conditions:**

- IgE-Mediated Hypersensitivity

- Allergy

**Keywords:**

- IgE-mediated allergy

- Beta-lactams

- Ertapenem

- Cross-reactivity

- Immediate-type skin tests

- Intravenous tolerance tests

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with IgE-mediated allergy to beta-lactams

**Intervention Names:**

- Drug: ertapenem

**Label:** ertapenem, tolerance tests

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ertapenem, tolerance tests

**Description:** intravenous, 1 gram, once

**Name:** ertapenem

**Other Names:**

- Invanz

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Cross-reactivity between beta-lactams and ertapenem.

**Time Frame:** 1 day

#### Secondary Outcomes

**Measure:** Tolerability of ertapenem in patients with IgE-mediated allergy to beta-lactams.

**Time Frame:** 1 day

### Eligibility Module

**Eligibility 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

**Maximum Age:** 75 Years

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dschiavino@rm.unicatt.it

**Name:** Domenico Schiavino, MD

**Phone:** 0630155896

**Phone Ext:** +39

**Role:** CONTACT

**Contact 2:**

**Email:** alessandrobuonomo@hotmail.com

**Name:** Alessandro Buonomo, MD

**Phone:** 0630155896

**Phone Ext:** +39

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rome

**Contacts:**

***Contact 1:***

- **Email:** dschiavino@rm.unicatt.it

- **Name:** Domenico Schiavino, MD

- **Role:** CONTACT

***Contact 2:***

- **Email:** alessandrobuonomo@hotmail.com

- **Name:** Alessandro Buonomo, MD

- **Role:** CONTACT

***Contact 3:***

- **Name:** Domenico Schiavino

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Italy

**Facility:** Allergy Department, Catholic University of the Sacred Heart

**Zip:** 00168

#### Overall Officials

**Official 1:**

**Affiliation:** Allergy Department, Catholic University of the Sacred Heart

**Name:** Domenico Schiavino, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10018

- Name: Hypersensitivity

- Relevance: HIGH

- As Found: Hypersensitivity

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: HIGH

- As Found: IgE-Mediated Hypersensitivity

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006967

- Term: Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

### Intervention Browse Module - Ancestors

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10789

- Name: Lactams

- Relevance: LOW

- As Found: Unknown

- ID: M25772

- Name: beta-Lactams

- Relevance: LOW

- As Found: Unknown

- ID: M1887

- Name: Ertapenem

- Relevance: HIGH

- As Found: Egypt

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077727

- Term: Ertapenem

### Misc Info Module

- Version Holder: 2024-05-24
