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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Procedure (phase I) | No Intervention | Antibiotic prescription following in vitro sensitivity test according to each surgeon's will. | |
| Implemented procedure | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implemented procedure | Behavioral | Prescription following in vitro sensitivity test implemented with MIC/Breakpoint ratio and penetration of antibiotic in the site of infection. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guglielmo Borgia | Federico II University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Naples Federico II | Naples | Naples | I-80131 | Italy | ||
| University of Naples Federico II |
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| ID | Term |
|---|---|
| D002481 | Cellulitis |
| D017192 | Skin Diseases, Bacterial |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D007239 | Infections |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D000069349 | Linezolid |
| D014640 | Vancomycin |
| D017576 | Daptomycin |
| D017334 | Teicoplanin |
| D000078304 | Tigecycline |
| ID | Term |
|---|---|
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 |
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|
| 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) |
| Naples |
| I-80131 |
| Italy |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D012871 | Skin Diseases |
| Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000081 | Acetamides |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D000077427 | Lipoglycopeptides |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |