Clinical Efficacy of FACTIVE: Community-acquired Pneumonia (CAP)
With a broad spectrum of indicated pathogens (including Multi-drug resistant S pneumoniae (MDRSP) for CAP), a short dosing regimen, and proven once-daily efficacy, FACTIVE may be an appealing new treatment option for patients with mild to moderate CAP.
[Clinical studies of oral FACTIVE 320 mg qd for 5 – 14 days in patients with community-acquired pneumonia1,2,3,4,5 ]
Study | Design | Antibacterial agents & duration of therapy |
End of Therapy Clinical Success rate (%) |
Follow-up Clinical Success rate (%) |
Noninferiority proven at end of therapy and follow-up |
No. of patients (intent-to-treat population) |
---|---|---|---|---|---|---|
File et al. [2007] |
Multicenter, randomized, double-blind, parallel-group |
FACTIVE 320mg qd 5 days vs. 7days | 95.5 vs. 95.8 | 95 vs. 92.1 | Yes | 256 vs. 254 |
Lode et al [2002] |
Multicenter, randomized, open-label |
FACTIVE 7-14 days vs. Ceftriaxone 2g IV qd 1-7 days then cefuroxime 500mg bid 1-13 days | 95.9 vs. 96.1 | 92.2 vs. 93.4 | Yes | 172 vs. 173 |
Leophonte et al [2004] |
Multicenter, randomized, double-blind, double-dummy, parallel-group |
FACTIVE 7 days vs. Amoxicillin/ Clavulanate 1g/125mg tid 10 days |
95.3 vs. 90.1 | 88.7 vs. 87.6 | Yes | 167 vs. 153 |
File et al [2001] |
Multicenter, randomized, double-blind, parallel-group |
FACTIVE 7-14 days vs. Trovafloxacin 200mg qd 7-14 days |
95.8 vs. 93.6 | 94.0 vs. 89.9 | Yes | 290 vs. 281 |
Successful clinical study compared the efficacy of FACTIVE (320 mg, qd, oral 5-14days) with other antibiotic comparators in patients with CAP. FACTIVE is a potent new quinolone indicated for the treatment of mild to moderate CAP due to a range of common community-acquired pathogens.
[CAP: 5-day vs. 7-day FACTIVE Clinical Response1]
The study was a double-blind, randomized, actively-controlled, parallel-group noninferiority study of FACTIVE 320 mg qd 5day therapy vs. FACTIVE 320 mg qd 7-day therapy at end of therapy and follow-up. A conclusion of noninferior efficacy of FACTIVE was established if the lower limit of the confidence interval was ≥–10%. FACTIVE once daily for 5 days is as effective as 7 days in the PP population with respect to clinical, bacteriological and radiological efficacy.
[Clinical Success rate in patients with severe CAP6]
In the comparative study, FACTIVE was found to be highly effective and well tolerated in the treatment of mild-to-moderately severe CAP.