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

Primary Purpose

Infection of Skin and/or Subcutaneous Tissue

Status
Withdrawn
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Implemented procedure
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection of Skin and/or Subcutaneous Tissue focused on measuring Bacterial infection of skin or soft tissues

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Naples Federico II

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Procedure (phase I)

Implemented procedure

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Complete recovery rate from infection
Complete resolution of fever, leukocytosis, and any local signs of infection

Secondary Outcome Measures

Time to recovery from infection.
Days to recovery completely from infection.
Partial response
Improvement of fever, leukocytosis, and any local signs of infection
Rate of non responders
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

Full Information

First Posted
February 29, 2012
Last Updated
December 28, 2012
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT01551719
Brief Title
Clinical Usefulness of Mic/Breakpoint Ratio and Penetration in Tissues. A Prospective Study of Clinical Validation
Official Title
Clinical Usefulness of Mic/Breakpoint Ratio and Penetration in Tissues. A Prospective Study of Clinical Validation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Withdrawn
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection of Skin and/or Subcutaneous Tissue
Keywords
Bacterial infection of skin or soft tissues

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Procedure (phase I)
Arm Type
No Intervention
Arm Description
Antibiotic prescription following in vitro sensitivity test according to each surgeon's will.
Arm Title
Implemented procedure
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Implemented procedure
Other Intervention Name(s)
MIC/Breakpoint ratio and tissue penetration for available antibiotics e.g., - Semisynthetic Penicillins, - Cephalosporins, - Linezolid, - Vancomycin, - Daptomycin, - Teicoplanin, - Tigecycline
Intervention Description
Prescription following in vitro sensitivity test implemented with MIC/Breakpoint ratio and penetration of antibiotic in the site of infection.
Primary Outcome Measure Information:
Title
Complete recovery rate from infection
Description
Complete resolution of fever, leukocytosis, and any local signs of infection
Time Frame
At the end of treatment (an expected average of 10 days)
Secondary Outcome Measure Information:
Title
Time to recovery from infection.
Description
Days to recovery completely from infection.
Time Frame
At the end of treatment (an expected average of 10 days)
Title
Partial response
Description
Improvement of fever, leukocytosis, and any local signs of infection
Time Frame
At the end of treatment (an expected average of 10 days)
Title
Rate of non responders
Description
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
Time Frame
At the end of treatment (an expected average of 10 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guglielmo Borgia
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Naples Federico II
City
Naples
ZIP/Postal Code
I-80131
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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