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WithdrawnNCT01551719Updated Dec 31, 2012

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

An interventional study of Implemented procedure in Infection of Skin and/or Subcutaneous Tissue, sponsored by Federico II University. Withdrawn at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-31.

Sponsored by Federico II University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Infection of Skin and/or Subcutaneous Tissue

Keywords

  • Bacterial infection of skin or soft tissues
03

In context

Skin Diseases, Infectious

86 studies on the registry are indexed under Skin Diseases, Infectious; 4 are open to participants now.

Browse Skin Diseases, Infectious studies →

Lead sponsor

Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Age \< 18 years
  • Inability to sign informed consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralImplemented procedure

    Prescription following in vitro sensitivity test implemented with MIC/Breakpoint ratio and penetration of antibiotic in the site of infection.

    Also known as: MIC/Breakpoint ratio and tissue penetration for available antibiotics e.g., - Semisynthetic Penicillins, - Cephalosporins, - Linezolid, - Vancomycin, - Daptomycin, - Teicoplanin, - Tigecycline

06

What researchers measure

Primary outcomes

  1. Complete recovery rate from infection

    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 outcomes

  1. Time to recovery from infection.

    Days to recovery completely from infection.

    Time frame: At the end of treatment (an expected average of 10 days)

  2. Partial response

    Improvement of fever, leukocytosis, and any local signs of infection

    Time frame: At the end of treatment (an expected average of 10 days)

  3. 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

    Time frame: At the end of treatment (an expected average of 10 days)

07

Study locations

1 site
  • University of Naples Federico II
    Naples, I-80131, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01551719
Lead sponsor
Federico II University
Responsible party
Prof. Guglielmo Borgia (Full Professor, Federico II University) — Principal investigator
First posted
Mar 13, 2012
Start date
Mar 2012
Primary completion
Mar 2013 (estimated)
Completion
Mar 2013 (estimated)
Last update
Dec 31, 2012

Study contacts

Guglielmo Borgia
principal investigator · Federico II University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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