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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This study has been withdrawn prior to enrollment.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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Complete recovery rate from infection [ Time Frame: At the end of treatment (an expected average of 10 days) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Days to recovery completely from infection.

  • Partial response [ Time Frame: At the end of treatment (an expected average of 10 days) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Health Authority: Italy: Ethics Committee

Keywords provided by Federico II University:
Bacterial infection of skin or soft tissues

Additional relevant MeSH terms:
Skin Diseases, Infectious
Infection
Skin Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
 Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015