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

December 28, 2012 updated by: Prof. Guglielmo Borgia, Federico II University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, I-80131
        • University of Naples Federico II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Procedure (phase I)
Antibiotic prescription following in vitro sensitivity test according to each surgeon's will.
Experimental: 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.
Behavioral: Implemented procedure
Prescription following in vitro sensitivity test implemented with MIC/Breakpoint ratio and penetration of antibiotic in the site of infection.
Other Names:
  • MIC/Breakpoint ratio and tissue penetration for available antibiotics e.g.
  • - Semisynthetic Penicillins
  • - Cephalosporins
  • - Linezolid
  • - Vancomycin
  • - Daptomycin
  • - Teicoplanin
  • - Tigecycline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete recovery rate from infection
Time Frame: At the end of treatment (an expected average of 10 days)
Complete resolution of fever, leukocytosis, and any local signs of infection
At the end of treatment (an expected average of 10 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recovery from infection.
Time Frame: At the end of treatment (an expected average of 10 days)
Days to recovery completely from infection.
At the end of treatment (an expected average of 10 days)
Partial response
Time Frame: At the end of treatment (an expected average of 10 days)
Improvement of fever, leukocytosis, and any local signs of infection
At the end of treatment (an expected average of 10 days)
Rate of non responders
Time Frame: At the end of treatment (an expected average of 10 days)

Treatment failure, relapse and death. Failure is defined as no improvement or even worsening of the signs and symptoms of infection.

Relapse is defined as the resumption of infection with the same organism at any body part within one month after completion of treatment
At the end of treatment (an expected average of 10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Investigators

  • Principal Investigator: Guglielmo Borgia, Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

February 29, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (Estimate)

March 13, 2012

Study Record Updates

Last Update Posted (Estimate)

December 31, 2012

Last Update Submitted That Met QC Criteria

December 28, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 52/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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