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Clinical Data for Avelox® in Complicated Intra-Abdominal Infections
The use of Avelox® (moxifloxacin) in the treatment of complicated intra-abdominal infections (cIAI) has been studied in three published trials. Clinical comparators included piperacillin/tazobactam followed by oral amoxicillin/clavulanate, ceftriaxone in combination with metronidazole followed or not by oral amoxicillin/clavulanate. Avelox® was found to have comparable efficacy to each of the three comparators in terms of clinical cure rate. Avelox® monotherapy was similarly tolerated to all comparators.
Table 1. Summary of a Selection of Clinical Trials of Avelox® in Complicated Intra-Abdominal Infections
(Author)
| Study/Auth | MALANGONI1 (MALANGONI et al.) |
| Study Design | Prospective, multinational, multicentre, randomised, double-blind study |
| Avelox® Regimen | Dose:IV/PO 400mg od Duration: 5-14 days |
| Comparator | Drug/dose:Piperacillin/tazobactam IV 3.0/0.375g qds followed by amoxicillin/clavulanate PO 800/114mg bd Duration: 5-14 days |
| No. of patients (n) † |
379 |
| Primary Endpoint | Clinical cure 25-50 days after start of therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint: 80.0% (Avelox® 400mg) vs 78.0% (piperacillin/tazobactam followed by amoxicillin/clavulanate) (95% CI: -7.4, 9.3) non-inferiority between treatment groups  Comparable cure rates in sub-analyses of patients by
|
| Safety Results (Avelox® vs Comparator)* | Percentage of patients experiencing a drug-related adverse event: 25.0% (Avelox® 400mg) vs 28.0% (piperacillin/tazobactam followed by amoxicillin/clavulanate) |
| Study/Auth | AIDA2 (WEISS et al.) |
| Study Design | Prospective, multinational, multicentre, randomised, open-label study |
| Avelox® Regimen | Dose:IV/PO 400mg od Duration:5-14 days |
| Comparator | Drug/dose:Ceftriaxone IV 2g od + metronidazole IV 500mg tds followed by amoxicillin/clavulanate PO 500/125mg tds Duration:5-14 days |
| No. of patients (n) † |
511 |
| Primary Endpoint | Clinical cure rate 28-42 days after start of therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint: 80.9% (Avelox® 400mg) vs 82.3% (ceftriaxone + metronidazole followed by amoxicillin/clavulanate) (95% CI: -8.9, 4.2) non-inferiority between treatment groups |
| Safety Results (Avelox® vs Comparator)* | Percentage of patients experiencing a drug-related adverse event: 19.0% (Avelox® 400mg) vs 12.2% (ceftriaxone + metronidazole followed by amoxicillin/clavulanate) (P=0.75) no statistically significant difference between treatment groups |
| Study/Auth | DRAGON3 (SOLOMKIN et al.) |
| Study Design | Prospective, multinational, multicentre, randomised, double-blind study |
| Avelox® Regimen | Dose:IV 400mg od Duration:3-14 days |
| Comparator | Drug/dose: Cefriaxone IV 2g od + metronidazole IV 500mg bd Duration:3-14 days |
| No. of patients (n) † |
345 |
| Primary Endpoint | Clinical cure 10-14 days after therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint: 90.2% (Avelox® 400mg) vs 96.5% (ceftriaxone + metronidazole) (95% CI: -11.7, -1.7) non-inferiority between treatment groups Following adjustment for causative organisms (monomicrobial vs. polymicrobial infections) and primary diagnosis, a 95% CI of -10.0 to 0.3 (P=0.209) was obtained. |
| Safety Results (Avelox® vs Comparator)* | Percentage of patients experiencing a drug-related adverse event: 4.4% (Avelox® 400mg) vs. 5.0% (ceftriaxone + metronidazole) (P=1.0) no statistically significant difference between treatment groups |
† 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
- Malagoni MA, et al. Ann Surg 2006; 244: 204-211.
- Weiss G, et al. J Chemother 2009; 21: 170-180.
- Solomkin J, et al. Int J Antimicrob Agents 2009 ; Article in Press.
Licensed indications differ from country to country please ensure you consult your local prescribing information before prescribing Avelox®.
For further information on using Avelox® in the management of bacterial infections, please consult your local country specific prescribing information.
