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

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ClinicalTrials.gov Identifier: NCT01551719
Recruitment Status : Withdrawn
First Posted : March 13, 2012
Last Update Posted : December 31, 2012
Sponsor:
Information provided by (Responsible Party):
Prof. Guglielmo Borgia, Federico II University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Infection of Skin and/or Subcutaneous Tissue Behavioral: Implemented procedure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Usefulness of Mic/Breakpoint Ratio and Penetration in Tissues. A Prospective Study of Clinical Validation
Study Start Date : March 2012
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Infections
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Time to recovery from infection. [ Time Frame: At the end of treatment (an expected average of 10 days) ]
    Days to recovery completely from infection.

  2. 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

  3. 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



Eligibility Criteria
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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: December 31, 2012
Last Verified: December 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