FACTIVE: Package Insert and Label Information (Page 5 of 7)

Community Acquired Pneumonia (CAP)

5 Day Treatment Regimen

To evaluate the safety and efficacy of a 5-day course of FACTIVE, 510 outpatient and hospitalized adults with clinically and radiologically determined mild to moderate community-acquired pneumonia were clinically evaluated in a double-blind, randomized, prospective, multicenter study comparing FACTIVE 320 mg for five days to FACTIVE 320 mg for seven days (Study OP-634-001).

Clinical success rates in the clinically evaluable population were 95.0% in the 5 day group and 92.1% in the 7 day group.Table 7. Clinical Response at Follow-Up (Test of Cure): Study OP-634-001

Drug Regimen

Success Rate % (n/N)

Treatment Difference (95% CI)

Study OP-634-001

FACTIVE 320 mg x 5 days

95.0 (230/242)

3.0 (-1.5, 7.4)

FACTIVE 320 mg x 7 days

92.1 (209/227)

The microbiological efficacy of the 5-day regimen was documented for pathogens listed in Table 8 below.Table 8. Bacterial Eradication by Pathogen for Patients Treated with FACTIVE in Study OP-634-001

5-day

7-day

Pathogen

n/N

%

n/N

%

Streptococcus pneumoniae

26/26

100

34/40

85.0

Mycoplasma pneumoniae

22/25

88.0

19/20

95.0

Haemophilus influenzae

21/22

95.5

18/18

100

Chlamydia pneumoniae

17/18

94.4

30/31

96.8

7 Day Treatment Regimen

Previous clinical studies evaluated the efficacy of FACTIVE in a 7-day treatment of CAP in adults. This clinical program consisted of three double-blind, randomized, actively-controlled clinical studies (studies 011, 012, and 049) and one open-label, actively-controlled study (study 185). In addition, two uncontrolled studies (studies 061 and 287) were conducted. Three of the studies, controlled study 011 and the uncontrolled studies, had a fixed 7-day duration of treatment for FACTIVE. Controlled study 011 compared a 7-day course of FACTIVE with a 10-day treatment course of amoxicillin/clavulanate (1g/125 mg TID) and clinical success rates were similar between treatment arms. The results of comparative studies 049, 185, and 012 were supportive although treatment duration could have been 7 to 14 days. The results of the clinical studies with a fixed 7-day duration of FACTIVE are shown in Table 9.

Table 9. Clinical Response at Follow-Up (Test of Cure): CAP Studies with a Fixed 7-day Duration of Treatment

Drug Regimen

Success Rate % (n/N)

Treatment Difference (95% CI)*

Study 011

FACTIVE 320 mg x 7 days

88.7 (102/115)

1.1 (-7.3, 9.5)

Amoxicillin/clavulanate1 g/125 mg TID x 10 days

87.6 (99/113)

Study 061

FACTIVE 320 mg x 7 days

91.7 (154/168)

(86.1, 95.2)

Study 287

FACTIVE 320 mg x 7 days

89.8 (132/147)

(84.9, 94.7)

*For uncontrolled studies, the 95% CI around the success rate is shown

The combined bacterial eradication rates for patients treated with a fixed 7-day treatment regimen of FACTIVE are shown in Table 10.Table 10. Bacterial Eradication by Pathogen for Patients Treated with FACTIVE in Studies with a Fixed 7-day Duration of Treatment

Pathogen

n/N

%

S. pneumoniae

102/117

87.2

M. pneumoniae

40/42

95.2

H. influenzae

48/53

90.6

C. pneumoniae

43/45

95.6

K. pneumoniae

18/20

90.0

M. catarrhalis

11/12

91.7

7 Day Treatment Regimen of Community-Acquired Pneumonia Due to Multi-Drug Resistant Streptococcus pneumoniae (MDRSP)

FACTIVE was also effective in the treatment of CAP due to multi-drug resistant Streptococcus pneumoniae (MDRSP*). Of 35 patients with MDRSP treated for 7 days, 29 (82.9%) achieved clinical and bacteriological success at follow-up. The clinical and bacteriological success for the 35 patients with MDRSP isolates are shown in Table 11.

*MDRSP: multi-drug resistant Streptococcus pneumoniae , includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥2 μg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole.Table 11. Clinical and Bacteriological Success for 35 Patients Treated with FACTIVE in CAP Studies with a 7-day Duration of Treatment for MDRSP

Screening Susceptibility

Clinical Success

Bacteriological Success

n/Na % n/Nb %

Penicillin-resistant

15/16

93.8

15/16

93.8

2nd generation cephalosporin-resistant

20/22

90.9

20/22 90.9

Macrolide-resistantc

24/28

85.7

23/28

82.1

Trimethoprim/sulfamethoxazole-resistant

23/26

88.5

23/26

88.5

Tetracycline-resistant

21/27

77.8

20/27

74.1

a n = the number of patients successfully treated; N = number of patients with MDRSP
b n = the number of bacteriological isolates successfully treated; N = number of isolates studied
c Macrolide antibiotics tested include clarithromycin and erythromycin

Not all isolates were resistant to all antimicrobial classes tested. Success and eradication rates are summarized in Table 12 below.Table 12. Resistant Streptococcus pneumoniae Clinical Success and Bacteriological Eradication Rates

S. pneumoniae with MDRSP

Clinical Cure Rate

Bacteriological Eradication Rate

n/N

%

n/N

%

Resistant to 2 antimicrobials

8/11

72.7

7/11

63.6

Resistant to 3 antimicrobials

5/7

71.4

5/7

71.4

Resistant to 4 antimicrobials

8/9

88.9

8/9

88.9

Resistant to 5 antimicrobials

8/8

100

8/8

100

Bacteremia with MDRSP

3/3

100

3/3

100

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