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Clinical Data for Avelox® in Complicated Skin and Skin Structure Infections
Two major studies of Avelox® (moxifloxacin) use in complicated skin and skin structure infections (cSSSI) have shown similar efficacy with similar safety profiles, when compared with the intravenous therapy piperacillin-tazobactam followed by per oral (PO) amoxicillin-clavulanate.
Table 1. Summary of Clinical Trials of Avelox® in Complicated Skin and Skin Structure Infections
Study
(Author)
(Author)
| Study/Auth | RELIEF1 (GYSSENS et al.) |
| Study Design | Prospective, multinational, multicentre, randomised, double-blind study |
| Avelox® Regimen | Dose:IV/PO 400mg od Duration:7-21 days |
| Comparator | Drug/dose: Piperacillin-tazobactam IV 4.0/0.5g tds followed by amoxicillin/clavulanate PO 875/125mg bd Duration:7-21 days |
| No. of patients (n) † |
668 |
| Primary Endpoint | Clinical cure at 14-28 days post therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint: 88.7% (Avelox® 400mg) vs 89.6% (pipericillin-tazobactam followed by amoxicillin/clavulanate) (95% CI: -5.2, 4.0) non-inferiority between treatment groups  |
| Safety Results (Avelox® vs Comparator)* | Percentage of patients experiencing a drug-related adverse event: 8.6% (Avelox® 400mg) vs 7.3% (pipericillin-tazobactam followed by amoxicillin/clavulanate) (P=0.60) no statistically significant difference between treatment groups |
| Study/Auth | GIORDANO2 (GIORDANO et al.) |
| Study Design | Prospective, multinational, multicentre, randomised, double-blind study |
| Avelox® Regimen | Dose:IV/PO 400mg od Duration:7-14 days |
| Comparator | Drug/dose:Piperacillin-tazobactam IV 3.0/0.375g qds followed by amoxicillin/clavulanate PO 800/114mg bd Duration:7-14 days |
| No. of patients (n) † |
367 |
| Primary Endpoint | Clinical cure or resolution at 10-42 days after therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint: 79.0% (Avelox® 400mg) vs 82.0% (pipericillin-tazobactam followed by amoxicillin/clavulanate) (95% CI: -12.04, 3.29) non-inferiority between treatment groups |
| Safety Results (Avelox® vs Comparator)* | Percentage of patients experiencing a drug-related adverse event: 31.0% (Avelox® 400mg) vs 30.0% (pipericillin-tazobactam followed by amoxicillin/clavulanate) |
Table Key
† All patient numbers are the per protocol population
* P value data are not always included in the original paper
od Once daily
bd Twice daily
tds Three times daily
qds Four times daily
CI Confidence interval
IV Intravenous
PO Per oral
References
- Gyssens IC,et al. Presented at the European Congress of Clinical Microbiology and Infectious Diseases, 16-19 May 2009. P1
- Giordano P, et al. Int J Antimicrob Agents 26 (2005) 357–365.
