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azithromycin for Injection, USP - ADD-VANTAGE Clinical Studies

14 CLINICAL STUDIES

14.1 Community-Acquired Pneumonia

In a controlled trial of community-acquired pneumonia performed in the U.S., azithromycin (500 mg as a single daily dose by the intravenous route for 2 to 5 days, followed by 500 mg/day by the oral route to complete 7 to 10 days therapy) was compared to cefuroxime (2250 mg/day in three divided doses by the intravenous route for 2 to 5 days followed by 1000 mg/day in two divided doses by the oral route to complete 7 to 10 days therapy), with or without erythromycin. For the 291 patients who were evaluable for clinical efficacy, the clinical outcome rates, i.e., cure, improved, and success (cure + improved) among the 277 patients seen at 10 to 14 days post-therapy were as follows:

Clinical Outcome

Azithromycin

Comparator

Cure

46%

44%

Improved

32%

30%

Success (Cure + Improved)

78%

74%

In a separate, uncontrolled clinical and microbiological trial performed in the U.S., 94 patients with community-acquired pneumonia who received azithromycin in the same regimen were evaluable for clinical efficacy. The clinical outcome rates, i.e., cure, improved, and success (cure + improved) among the 84 patients seen at 10 to 14 days post-therapy were as follows:

Clinical Outcome

Azithromycin

Cure

60%

Improved

29%

Success (Cure + Improved)

89%

Microbiological determinations in both trials were made at the pre-treatment visit and, where applicable, were reassessed at later visits. Serological testing was done on baseline and final visit specimens. The following combined presumptive bacteriological eradication rates were obtained from the evaluable groups:

Combined Bacteriological Eradication Rates for Azithromycin:

a   Nineteen of twenty-four patients (79%) with positive blood cultures for S. pneumoniae were cured (intent-to-treat analysis) with eradication of the pathogen.

(at last completed visit)

Azithromycin

S. pneumoniae

64/67

(96%)a

H. influenzae

41/43

(95%)

M. catarrhalis

9/10

(90%)

S. aureus

9/10

(90%)

The presumed bacteriological outcomes at 10 to 14 days post-therapy for patients treated with azithromycin with evidence (serology and/or culture) of atypical pathogens for both trials were as follows:

Evidence of Infection

Total

Cure

Improved

Cure + Improved

Mycoplasma pneumoniae

18

11 (61%)

5 (28%)

16 (89%)

Chlamydia pneumoniae

34

15 (44%)

13 (38%)

28 (82%)

Legionella pneumophila

16

5 (31%)

8 (50%)

13 (81%)

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