Infection of Skin and/or Subcutaneous Tissue Clinical Trial
Official title:
Clinical Usefulness of Mic/Breakpoint Ratio and Penetration in Tissues. A Prospective Study of Clinical Validation
| Verified date | December 2012 |
| Source | Federico II University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | University of Naples Federico II | Naples |
| Lead Sponsor | Collaborator |
|---|---|
| Federico II University |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No |
| Secondary | Time to recovery from infection. | Days to recovery completely from infection. | At the end of treatment (an expected average of 10 days) | No |
| Secondary | Partial response | Improvement of fever, leukocytosis, and any local signs of infection | At the end of treatment (an expected average of 10 days) | No |
| Secondary | 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) | No |