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Clinical Data for Avelox® in Community Acquired Pneumonia
The use of Avelox® (moxifloxacin) in the treatment of community acquired pneumonia (CAP) has been studied in nine large clinical trials in both the community and hospital settings. Clinical comparators have included beta-lactams and macrolides both alone and in combination, and levofloxacin either alone or in combination with ceftriaxone. Avelox® was found to have superior efficacy to amoxicillin/clavulanate in terms of clinical cure rate in the TARGET5 study and equivalent efficacy with other comparators in other studies. Oral Avelox® monotherapy was found to be better tolerated than amoxicillin and/or Clarithromycin in the CAP 20001 study and was similarly tolerated to other comparators in other studies.
Table 1. Summary of Selection of Clinical Trials of Avelox® in Community Acquired Pneumonia
Study
(Author)
(Author)
- CAP 20001
(TORRES, et al.) - CAP12
(HOEFFKEN, et al.) - CAP53
(PETITPRETZ, et al.) - FOGARTY4
(FOGARTY, et al.) - TARGET5
(FINCH, et al.) - MOXIRAPID6
(WELTE , et al.) - CAPRIE7
(ANZUETO, et al.) - MOTIV8
(TORRES, et al.) - PORTIER9
(PORTIER, et al.)
| Study/Auth | CAP 20001 (TORRES, et al.) |
| Study Design | Prospective, multinational, multicentre, randomised, double-blind study |
| Avelox® Regimen | Dose: PO 400mg od Duration:Up to 14 days |
| Comparator | Drug/dose: Amoxicillin PO 1 g tds or clarithromycin PO 500mg bd alone or in combination Duration:Up to 14 days |
| No. of patients (n) † |
446 |
| Primary Endpoint | Clinical cure at 7-10 days after therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint: 93.5% (Avelox® 400mg) vs 93.9% (comparator therapy) (95% CI: -4.2, 3.3) non-inferiority between treatment groups  At 28-35 days follow-up continued clinical cure: 95.3% (Avelox® 400mg) vs 93.7% (comparator therapy) (95% CI: -2.2, 5.2%) non-inferiority between treatment groups |
| Safety Results (Avelox® vs Comparator)* | Percentage of patients experiencing a drug-related adverse event: 20.0% (Avelox® 400mg) vs 31.0% (comparator therapy) (P=0.004) statistically significant difference between treatment groups |
| Study/Auth | CAP12 (HOEFFKEN, et al.) |
| Study Design | Prospective, multinational, multicentre, randomised, double-blind study |
| Avelox® Regimen | Dose: PO 200mg or PO 400mg od Duration:10 days Note: Avelox® is not licensed for use at a dose of 200mg. Please refer to your local prescribing information for full details of the licensed dosing schedule. |
| Comparator | Drug/dose: Clarithromycin PO 500mg bd Duration: 10 days |
| No. of patients (n) † |
538 |
| Primary Endpoint | Clinical cure at 3-5 days after therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint: 93.9% (Avelox® 200mg) vs 94.3% (clarithromycin) (95% CI: -5.2, 4.8) non-inferiority between treatment groups 94.4% (Avelox® 400mg) vs 94.3% (clarithromycin) (95% CI: -6.7, 4.1) non-inferiority between treatment groups 93.9% (Avelox® 200mg) vs 94.4% (Avelox® 400mg) (95% CI: -5.4, 4.6) non-inferiority between treatment groups |
| Safety Results (Avelox® vs Comparator)* |
Percentage of patients experiencing a drug-related adverse event: 35.8% (Avelox® 200 mg) vs 37.5% (Avelox® 400 mg) vs 36.5% (clarithromycin) |
| Study/Auth | CAP54 (PETITPRETZ, et al.) |
| Study Design | Prospective, multinational, multicentre, randomised, double-blind study |
| Avelox® Regimen | Dose: PO 400mg od Duration:10 days |
| Comparator | Drug/dose: Amoxicillin PO 1g tds Duration: 10 days |
| No. of patients (n) † |
362 |
| Primary Endpoint | Clinical cure at 3-5 days after therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint: 91.5% (Avelox® 400mg) vs 89.7% (amoxicillin) (95% CI: -4.2, 7.8) non-inferiority between treatment groups  |
| Safety Results (Avelox® vs Comparator)* |
Percentage of patients experiencing a drug-related adverse event: 28.0% (Avelox® 400mg) vs 20.2% (amoxicillin) |
| Study/Auth | FOGARTY4, (FOGARTY, et al.) |
| Study Design | Prospective, double blind, multicentre study |
| Avelox® Regimen | Dose: PO 400mg od Duration:10 days |
| Comparator | Drug/dose: Clarithromycin PO 500mg bd Duration: 10 days |
| No. of patients (n) † |
382 |
| Primary Endpoint | Overall clinical response (cure or clinical improvement after EOT and follow up) |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint: 95% (Avelox® 400mg) vs 95% (clarithromycin) (95% CI: -3.7, 5.3) non-inferiority between treatment groups See Figure 1 |
| Safety Results (Avelox® vs Comparator)* |
Percentage of patients experiencing a drug-related adverse event: 35.0% (Avelox® 400mg) vs 34.0% (clarithromycin) |
| Study/Auth | TARGET5 (FINCH, et al.) |
| Study Design | Prospective, multinational, multicentre, randomised, open-label study |
| Avelox® Regimen | Dose: IV 400mg od followed by PO 400mg Duration:7-14 days |
| Comparator | Drug/dose: Amoxicillin/clavulanate IV 1.2 g tds followed by amoxicillin/clavulanate PO 625mg tds ± clarithromycin IV/PO 500mg bd Duration:7-14 days |
| No. of patients (n) † |
538 |
| Primary Endpoint | Clinical cure at 5-7 days after therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint (overall population): 93.4% (Avelox® 400mg) vs 85.4% (amoxicillin/clavulanate ± clarithromycin) (P=0.004; 95% CI: 2.91, 13.19) superiority in favour of Avelox® Non-severe CAP: 94.6% (Avelox® 400mg) vs 84.7% (amoxicillin/clavulanate ± clarithromycin) Severe CAP: 92.2% (Avelox® 400mg) vs 84.7% (amoxicillin/clavulanate ± clarithromycin) At 21-28 days after therapy (overall population): 83.7% (Avelox® 400mg) vs 74.3% (amoxicillin/clavulanate ± clarithromycin) (95% CI: 2.60, 16.27) superiority in favour of Avelox® Clinical outcomes at days 5-7 and 21-28 post-treatment  Number of patients apyrexic by Day 2: 140 (58.6%) of Avelox® treated patients were apyrexic by day 2, whereas 119 (46.7%) of the patients in the comparator group were apyrexic by day 2 (P = 0.025 by log rank and P = 0.009 by Wilcoxon test) |
| Safety Results (Avelox® vs Comparator)* | Percentage of patients experiencing a drug-related adverse event: 38.9% (Avelox® 400mg) vs 38.9% (amoxicillin/clavulanate ± clarithromycin) |
| Study/Auth | MOXIRAPID6 (WELTE , et al.) |
| Study Design | Prospective, multinational, multicentre, randomised, open-label study |
| Avelox® Regimen | Dose: IV 400mg od followed by PO 400mg Duration:7-14 days |
| Comparator | Drug/dose: Ceftriaxone IV 2g od ± erythromycin IV 1g every 6-8 h Duration: 7-14 days |
| No. of patients (n) † |
317 |
| Primary Endpoint | Clinical response (cure or clinical improvement) 5-20 days after therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint: 85.7% (Avelox® 400mg) vs 86.5% (ceftriaxone ± erythromycin) at 5-20 days (P=0.1; 95% CI: -7.92, 7.09) non-inferiority between treatment groups Median time to fever resolution: 3.0 days (Avelox® 400mg) vs 4.0 days (ceftriaxone ± erythromycin) after treatment initiation (P<0.003) superiority in favour of Avelox® Mean time to hospital discharge: 9.8 days (Avelox® 400mg) vs 11.1 days (ceftriaxone ± erythromycin) (P<0.001) superiority in favour of Avelox® 
|
| Safety Results (Avelox® vs Comparator)* |
Percentage of patients experiencing a drug-related adverse event: 32.5% (Avelox® 400mg) vs 38.6% (ceftriaxone ± erythromycin) no statistically significant difference between treatment groups |
| Study/Auth | CAPRIE7 (ANZUETO, et al.) |
| Study Design | Prospective, multicentre, randomised, double-blind study |
| Avelox® Regimen | Dose: IV 400mg od followed by PO 400mg Duration:7-14 days |
| Comparator | Drug/dose: Levofloxacin IV/PO 500mg od Duration: 7-14 days |
| No. of patients (n) † |
281 |
| Primary Endpoint | Clinical cure at 5-21 days after therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients (overall population) achieving primary endpoint: 92.9% (Avelox® 400mg) vs 87.9% (levofloxacin) (P=0.2; 95% CI: -1.9, 11.9) non-inferiority between treatment groups Clinical recovery by days 3–5 after the start of treatment (overall population): 97.9% (Avelox® 400mg) vs 90.0% (levofloxacin) (P=0.01; 95% CI: 1.7, 14.1) superiority in favour of Avelox®  Severe CAP: 94.7% (Avelox® 400mg) vs 84.6% (levofloxacin) (P=0.5; 95% CI: -0.12, 0.32) non-inferiority between treatment groups Age 65-74 years: 90.0% (Avelox® 400mg) vs 85.0% (levofloxacin) (P=0.6; 95% CI: -0.09, 0.19) non-inferiority between treatment groups Age >75 years: 94.5% (Avelox® 400mg) vs 90.0% (levofloxacin) (P=0.4; 95% CI: -0.05, 0.14) non-inferiority between treatment groups |
| Safety Results (Avelox® vs Comparator)* |
Percentage of patients experiencing a drug-related adverse event: 26.2% (Avelox® 400mg) vs 22.6% (levofloxacin) (P=0.5) no statistically significant difference between treatment groups No difference in cardiac events (based on ECG monitoring) |
| Study/Auth | MOTIV8 (TORRES, et al.) |
| Study Design | Prospective, multinational, multicentre, randomised, double-blind study |
| Avelox® Regimen | Dose: IV or PO 400mg od Duration:7-14 days |
| Comparator | Drug/dose: Ceftriaxone IV 2g od + sequential levofloxacin IV/PO 500mg bd Duration: 7-14 days |
| No. of patients (n) † |
569 |
| Primary Endpoint | Clinical cure 4-14 days after therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint (overall population): 86.9% (Avelox® 400mg) vs 89.9% (ceftriaxone + levofloxacin) (95% CI: -8.1, 2.2) non-inferiority between treatment groups 
Pneumonia severity index (PSI) IV/V: 84.6% (Avelox® 400mg) vs 86.8% (ceftriaxone + levofloxacin) (95% CI: -9.0, 5.8) non-inferiority between treatment groups Pneumonia severity index (PSI) III: 90.2% (Avelox® 400mg) vs 94.6% (ceftriaxone + levofloxacin) (95% CI: -11.6, 1.9 P = n.s.) no statistically significant difference between treatment groups |
| Safety Results (Avelox® vs Comparator)* |
Percentage of patients experiencing treatment related adverse events: 56.5% (Avelox® 400mg) vs 52.9% (ceftriaxone + levofloxacin) (P=0.36) no statistically significant difference between treatment groups |
| Study/Auth | PORTIER9 (PORTIER, et al.) |
| Study Design | Prospective, multicentre, randomised , open-label study |
| Avelox® Regimen | Dose: 400mg PO od Duration:10 days |
| Comparator | Drug/dose: Amoxicillin/clavulanate PO 1,000/125mg tds + roxithromycin PO 150mg bd Duration: 10 days |
| No. of patients (n) † |
289 |
| Primary Endpoint | Clinical cure 5-7 days after therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint: 86.8% (Avelox® 400mg) vs 87.0% (amoxicillin/clavulanate + roxithromycin) (95% CI: -8.0, 7.6) non-inferiority between treatment groups See Figure 2 |
| Safety Results (Avelox® vs Comparator)* |
Percentage of patients experiencing a drug-related adverse event: 24.6% (Avelox® 400mg) vs 28.6% (amoxicillin/clavulanate + roxithromycin) (P=0.4) no statistically significant difference between treatment 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
IV Intravenous
PO Per oral
Data for Figure 1 is taken from FOGARTY, a pooled analysis of six, prospective, multicentre phase III trials (n=131) evaluating the efficacy of oral or sequential IV/oral moxifloxacin in the treatment of penicillin-, macrolide-, and multidrug-resistant S. pneumoniae10.
Pooled analysis of six prospective, multicenter phase III trials
Multidrug resistant = resistant to at least three antimicrobial classes
Figure 1. Avelox® : Highly Effective Clinical Cure Rates in S. pneumoniae Drug Resistant Isolates10
Data for Figure 2 is taken from the PORTIER trial, a prospective, multicentre, randomised, comparative, open-label study (n=289) comparing moxifloxacin 400mg PO od for 10 days with amoxicillin-clavulanate 1,000/125mg td + roxithromycin 150mg bd9.
Risk factors included age > 65 years, comorbidities (e.g. COPD, diabetes), alcohol consumption, and hospitalisation during the year preceding the study
All patient numbers are the per protocol population.
Figure 2. Clinical Success Rates at Test-of-Cure. Avelox® as Effective As One of The Recommended Combination Regimens In CAP Patients With Risk Factors9
References
- Torres A, et al. Eur Respir J 2003; 21: 135-143.
- Hoeffken G, et al. Respir Med 2001; 95: 553-564.
- Petitpretz P, et al. Chest 2001; 119: 185-195.
- Fogarty C, et al. Infect Med 1999; 16: 748-763.
- Finch R, et al. Antimicrob Agents Chemother 2002; 46: 46-54.
- Welte T, et al. Clin Infect Dis 2005; 41: 1697-1705.
- Anzueto A, et al. Clin Infect Dis 2006; 42: 73-81.
- Torres A, et al. Clin Infect Dis 2008; 46: 1499-1509.
- Portier H, et al. Eur J Microbiol Infect Dis 2005; 24: 367-376.
- Fogarty C et al. Int J Clin Pract 2005; 59: 1253–1259.
