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

Federico II University

Status: Withdrawn

Conditions: Infection of Skin and/or Subcutaneous Tissue

Treatments: Behavioral: Implemented procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT01551719

52/11

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard Procedure (phase I)

No Intervention group

Description:

Antibiotic prescription following in vitro sensitivity test according to each surgeon's will.

Implemented procedure

Experimental group

Description:

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.

Treatment:

Behavioral: Implemented procedure