NCT01159379

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 9, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 5, 2011

Status Verified

January 1, 2010

Enrollment Period

8 months

First QC Date

June 3, 2010

Last Update Submit

January 4, 2011

Conditions

IgE-Mediated HypersensitivityAllergy

Keywords

IgE-mediated allergyBeta-lactamsErtapenemCross-reactivityImmediate-type skin testsIntravenous tolerance tests

Outcome Measures

Primary Outcomes (1)

  • Cross-reactivity between beta-lactams and ertapenem.

    1 day

Secondary Outcomes (1)

  • Tolerability of ertapenem in patients with IgE-mediated allergy to beta-lactams.

    1 day

Study Arms (1)

ertapenem, tolerance tests

EXPERIMENTAL

Patients with IgE-mediated allergy to beta-lactams

Drug: ertapenem

Interventions

ertapenemDRUG

intravenous, 1 gram, once

Also known as: Invanz
ertapenem, tolerance tests

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • IgE-mediated allergy to at least one beta-lactam molecule

You may not qualify if:

  • positive allergy testing to ertapenem
  • chronic diseases
  • treatment with beta-blockers
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergy Department, Catholic University of the Sacred Heart

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Hypersensitivity, ImmediateHypersensitivity

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Domenico Schiavino, MD

    Allergy Department, Catholic University of the Sacred Heart

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Domenico Schiavino, MD

CONTACT

0630155896dschiavino@rm.unicatt.it

Alessandro Buonomo, MD

CONTACT

0630155896alessandrobuonomo@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2010

First Posted

July 9, 2010

Study Start

January 1, 2011

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

January 5, 2011

Record last verified: 2010-01

Locations

IT(1)