Oral gatifloxacin in outpatient community-acquired pneumonia: results from TeqCES, a community-based, open-label, multicenter study.
Gatifloxacin is an 8-methoxy fluoroquinolone with broad activity against respiratory tract pathogens, including those commonly associated with community-acquired pneumonia (CAP). To evaluate the efficacy and safety of oral gatifloxacin 400 mg once daily for seven to 14 days, community-based physicians enrolled adult outpatients with confirmed or suspected CAP in a prospective, single-arm, open-label, noncomparative study. Of 1488 clinically evaluable patients with radiographically confirmed or clinically suspected CAP, 1417 (95.2%) were cured. All strains of Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, the most commonly isolated pathogens, were susceptible to gatifloxacin. Penicillin nonsusceptibility was seen in 32.6% of S. pneumoniae isolates, and beta-lactamase production was detected in H. influenzae (26.9%) and M. catarrhalis (88%) isolates. Clinical cure rates of 91%, 94%, and 92% were achieved in patients with S. pneumoniae, H. influenzae, and M. catarrhalis, respectively. All seven patients with fully penicillin-resistant S. pneumoniae (MIC > or =2 micro g/ml) were cured. Gatifloxacin was well tolerated, with the most common drug-related adverse events being nausea (2.8%) and diarrhea (1.7%). Gatifloxacin is effective and well tolerated as empiric therapy for CAP in the outpatient community setting.
Gotfried
Mark
M
Pulmonary Associates, Phoenix, Arizona, USA. mgotfried@pol.net
Quinn
Thomas C
TC
Gothelf
Samantha
S
Wikler
Matthew A
MA
Webb
C Douglas
CD
Nicholson
Susan C
SC
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D017714:Community-Acquired Infections / Q000188:drug therapy* / Q000382:microbiology; D004334:Drug Administration Schedule; D005260:Female; D024841:Fluoroquinolones; D005500:Follow-Up Studies; D000077734:Gatifloxacin; D006801:Humans; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D018410:Pneumonia, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D000077734:Gatifloxacin