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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01551719

Enrollment

Registered

2012-03-13

Start date

2012-03-31

Completion date

2013-03-31

Last updated

2012-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection of Skin and/or Subcutaneous Tissue

Keywords

Bacterial infection of skin or soft tissues

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.

Interventions

BEHAVIORALImplemented procedure

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Complete recovery rate from infection	At the end of treatment (an expected average of 10 days)	Complete resolution of fever, leukocytosis, and any local signs of infection

Secondary

Measure	Time frame	Description
Time to recovery from infection.	At the end of treatment (an expected average of 10 days)	Days to recovery completely from infection.
Partial response	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	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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026