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

Not Applicable

Withdrawn

• Conditions: Infection of Skin and/or Subcutaneous Tissue
• Interventions: Behavioral: Implemented procedure

• Registration Number: NCT01551719
• Lead Sponsor: Federico II University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-29
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-13
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-28
• Last Update Posted: 2012-12-31
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Implemented procedure	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 Naples, Italy