Community-Acquired Pneumonia
Subjects with a diagnosis of mild-to-moderate community-acquired pneumonia were
evaluated in two, randomized, double-blind, multicenter studies. In both studies,
clinical and microbiologic evaluations were conducted for all subjects at the Test
of Cure (TOC) visit, 7 to 14 days post-treatment. In the first study, 247 subjects
were treated with a single 2.0 g oral dose of Zmax and 252 subjects were treated
with clarithromycin extended release, 1 g orally QD for 7 days.
In the second study, 211 subjects were treated with a single 2.0 g oral dose of
Zmax and 212 subjects were treated with levofloxacin, 500 mg orally QD for 7 days.
A patient was considered a cure if signs and symptoms related to the acute infection
had resolved, or if clinical improvement was such that no additional antibiotics
were deemed necessary; in addition, the chest x-ray performed at the TOC visit was
to be either improved or stable. The clinical response at TOC for the primary population,
Clinical Per Protocol Subjects, is presented in the table below.
Clinical response by pathogen in the Bacteriologic Per Protocol population, across
both studies, is presented below:
Acute Bacterial Maxillary Sinusitis
Adult subjects with a diagnosis of acute bacterial maxillary sinusitis were evaluated
in a randomized, double-blind, multicenter study; a maxillary sinus tap was performed
on all subjects at baseline. Clinical evaluations were conducted for all subjects
at the TOC visit, 7 to 14 days post-treatment. Two hundred seventy (270) subjects
were treated with a single 2.0 g oral dose of Zmax and 268 subjects were treated
with levofloxacin, 500 mg orally QD for 10 days. A subject was considered a cure
if signs and symptoms related to the acute infection had resolved, or if clinical
improvement was such that no additional antibiotics were deemed necessary. The clinical
response for the primary population, Clinical Per Protocol Subjects, is presented
below.
Clinical response by pathogen in the Bacteriologic Per Protocol population is presented
below.
