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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by (Responsible Party):

Prof. Guglielmo Borgia, Federico II University

ClinicalTrials.gov Identifier:

NCT01551719

First received: February 29, 2012

Last updated: December 28, 2012

Last verified: December 2012

History of Changes

Purpose

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.

Condition	Intervention
Infection of Skin and/or Subcutaneous Tissue	Behavioral: Implemented procedure


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Clinical Usefulness of Mic/Breakpoint Ratio and Penetration in Tissues. A Prospective Study of Clinical Validation

Resource links provided by NLM:

MedlinePlus related topics: Skin Infections

U.S. FDA Resources

Further study details as provided by Prof. Guglielmo Borgia, Federico II University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Time to recovery from infection. [ Time Frame: At the end of treatment (an expected average of 10 days) ]
Days to recovery completely from infection.
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
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


Enrollment:	0
Study Start Date:	March 2012
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01551719

Locations


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

Sponsors and Collaborators

Federico II University

Investigators


Principal Investigator:	Guglielmo Borgia	Federico II University

More Information


Responsible Party:	Prof. Guglielmo Borgia, Full Professor, Federico II University
ClinicalTrials.gov Identifier:	NCT01551719 History of Changes
Other Study ID Numbers:	52/11
Study First Received:	February 29, 2012
Last Updated:	December 28, 2012

Keywords provided by Prof. Guglielmo Borgia, Federico II University:


Bacterial infection of skin or soft tissues

Additional relevant MeSH terms:


Skin Diseases, Infectious Infection Skin Diseases Anti-Bacterial Agents	Cephalosporins Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents

ClinicalTrials.gov processed this record on June 23, 2017

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