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Clinical Data for Avelox® in Mild to Moderate Pelvic Inflammatory Disease
In two major studies of Avelox® (moxifloxacin) in mild to moderate pelvic inflammatory disease (PID), Avelox® monotherapy has been shown to be as effective as the combinations of ofloxacin with metronidazole and doxycycline with metronidazole (with ciprofloxacin as single dose). Avelox® was also better tolerated than ofloxacin with metronidazole.
Table 1. Summary of a Selection of Clinical Trials of Avelox® in Mild to Moderate Pelvic Inflammatory Disease
Study
(Author)
(Author)
| Study/Auth | MAIDEN1 (ROSS et al.) |
| Study Design | Prospective, multinational, multicentre, randomised, double-blind study |
| Avelox® Regimen | Dose:PO 400mg od Duration:14 days |
| Comparator | Drug/dose: Ofloxacin PO 400mg od + metronidazole PO 500mg bd Duration:14 days |
| No. of patients (n) † |
564 |
| Primary Endpoint | Clinical resolution 5-24 days after therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint: 90.2% (Avelox® 400mg) vs 90.7% (ofloxacin + metronidazole) (95% CI: -5.7, 4.0) non-inferiority between treatment groups  |
| Safety Results (Avelox® vs Comparator)* | Percentage of patients experiencing a drug-related adverse event: 22.5% (Avelox® 400mg) vs 30.9% (ofloxacin + metronidazole) (P=0.01) statistically significant difference between treatment groups |
| Study/Auth | HEYSTEK2 (HEYSTEK et al.) |
| Study Design | Prospective, multinational, multicentre, randomised, double-blind study |
| Avelox® Regimen | Dose:PO 400mg od Duration:14 days |
| Comparator | Drug/dose: Doxycycline PO 100mg bd + metronidazole PO 400mg tds + one single dose of 500mg ciprofloxacin PO Duration:14 days |
| No. of patients (n) † |
434 |
| Primary Endpoint | Clinical Success (resolution or improvement) at 2-14 days after therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint: 96.6% (Avelox® 400mg) vs 98.0% (doxycycline+ metronidazole + ciprofloxacin) (95% CI: -4.5, 1.6) non-inferiority between treatment groups |
| Safety Results (Avelox® vs Comparator)* | Percentage of patients experiencing a drug-related adverse event: 44.0% (Avelox® 400mg) vs 49.7% (doxycycline+ metronidazole + ciprofloxacin) (P=0.14) no statistically significant difference between groups |
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
CI Confidence interval
PO Per oral
References
- Ross JDC, et al. Sex Transm Infect 2006; 82:446-451.
- Heystek M, et al. Int J STD AIDS. 2009; 20: 690-695.
Licensed indications differ from country to country please ensure you consult your local prescribing information before prescribing Avelox®.
