Clinical Usefulness of Mic/Breakpoint Ratio and Penetration in Tissues. A Prospective Study of Clinical Validation

NCT ID: NCT01551719

Last Updated: 2012-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-03-31

Brief Summary

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The general objective of the study is to assess whether the implementation of the antibiotic essay with the Breakpoint/MIC ratio and data on penetration of the antibiotic in the site of infection may improve the outcome of infections compared to using only the standard procedures.

Detailed Description

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Conditions

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Infection of Skin and/or Subcutaneous Tissue

Keywords

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Bacterial infection of skin or soft tissues

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Procedure (phase I)

Antibiotic prescription following in vitro sensitivity test according to each surgeon's will.

Group Type NO_INTERVENTION

No interventions assigned to this group

Implemented procedure

Prescription following in vitro sensitivity test implemented with MIC/Breakpoint ratio and penetration of antibiotic in the site of infection, according to each surgeon's will.

Group Type EXPERIMENTAL

Implemented procedure

Intervention Type BEHAVIORAL

Prescription following in vitro sensitivity test implemented with MIC/Breakpoint ratio and penetration of antibiotic in the site of infection.

Interventions

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Implemented procedure

Prescription following in vitro sensitivity test implemented with MIC/Breakpoint ratio and penetration of antibiotic in the site of infection.

Intervention Type BEHAVIORAL

Other Intervention Names

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MIC/Breakpoint ratio and tissue penetration for available antibiotics e.g. - Semisynthetic Penicillins - Cephalosporins - Linezolid - Vancomycin - Daptomycin - Teicoplanin - Tigecycline

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Bacterial infections, with microbiological isolation, in one of the following tissues: skin, soft tissue or surgical wound infections

Exclusion Criteria

* Age \< 18 years
* Inability to sign informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Prof. Guglielmo Borgia

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guglielmo Borgia

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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University of Naples Federico II

Naples, Naples, Italy

Site Status

University of Naples Federico II

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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52/11

Identifier Type: -

Identifier Source: org_study_id