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Withdrawn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

Arm | Intervention/treatment |
---|---|
No Intervention: Standard Procedure (phase I)
Antibiotic prescription following in vitro sensitivity test according to each surgeon's will.
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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.
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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:
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- 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
- 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

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

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
Italy | |
University of Naples Federico II | |
Naples, Italy, I-80131 |
Principal Investigator: | Guglielmo Borgia | Federico II University |
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 |