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This study has been withdrawn prior to enrollment.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

February 29, 2012
December 28, 2012
March 2012
March 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01551719 on ClinicalTrials.gov Archive Site
  • 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

Same as current
Not Provided
Not Provided
 
Clinical Usefulness of Mic/Breakpoint Ratio and Penetration in Tissues. A Prospective Study of Clinical Validation
Clinical Usefulness of Mic/Breakpoint Ratio and Penetration in Tissues. A Prospective Study of Clinical Validation

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Infection of Skin and/or Subcutaneous Tissue
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
  • 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.
    Intervention: Behavioral: Implemented procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01551719
52/11
No
Prof. Guglielmo Borgia, Federico II University
Federico II University
Not Provided
Principal Investigator: Guglielmo Borgia Federico II University
Federico II University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP