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

Study Overview
=================
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.

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

Conditions
-----------------
Infection of Skin and/or Subcutaneous Tissue

Intervention / Treatment
-----------------
* Behavioral: Implemented procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Procedure (phase I)<br>Antibiotic prescription following in vitro sensitivity test according to each surgeon's will. | |
| Experimental: Implemented procedure<br>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<br>* Prescription following in vitro sensitivity test implemented with MIC/Breakpoint ratio and penetration of antibiotic in the site of infection.<br>* Other names: - Tigecycline;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery from infection. | Days to recovery completely from infection. | At the end of treatment (an expected average of 10 days) | 
| Partial response | Improvement of fever, leukocytosis, and any local signs of infection | At the end of treatment (an expected average of 10 days) | 
| 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 | At the end of treatment (an expected average of 10 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bacterial infection of skin or soft tissues