A prospective, randomized, multicenter comparative study of clinafloxacin versus a ceftriaxone-based regimen in the treatment of hospitalized patients with community-acquired pneumonia.
In an open-label, phase 3, randomized, multicenter study, clinafloxacin (200 mg/d) was compared to ceftriaxone (2 g/d; with or without erythromycin) in 527 patients with acute community-acquired bacterial pneumonia (CAP). Primary efficacy parameters were clinical cure rate and microbiologic eradication rates (by pathogen and by patient) determined 5-9 d post-therapy (test of cure; TOC). Clinical cure rates at TOC for the 2 treatment groups were equivalent in the intention-to-treat (clinafloxacin 79.3, ceftriaxone 78.6%), clinically evaluable (clinafloxacin 88.1, ceftriaxone 85.0%), modified intention-to-treat (clinafloxacin 82.6, ceftriaxone 86.9%) and microbiologically evaluable populations (clinafloxacin 86.2, ceftriaxone 86.2%). Microbiologic eradication rates were similar in the 2 treatment groups. Both drugs were tolerated. Treatment of hospitalized CAP patients with clinafloxacin is a reasonable choice, especially when a resistant pathogen is anticipated.
Petermann
W
W
Bruederkrankenaus St. Josef, Chefarzt der Medizinischen Abteilung. Paderborn. Germany.
Alegre-Martin
J
J
Odenholt
I
I
Phillips
M J
MJ
Willcox
P A
PA
Tack
K
K
Trostmann
U
U
Welling
L
L
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002443:Ceftriaxone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002511:Cephalosporins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017714:Community-Acquired Infections / Q000188:drug therapy; D003428:Cross Infection / Q000188:drug therapy; D004359:Drug Therapy, Combination / Q000008:administration & dosage / Q000627:therapeutic use*; D004917:Erythromycin / Q000627:therapeutic use; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008297:Male; D008875:Middle Aged; D018410:Pneumonia, Bacterial / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D002511:Cephalosporins; D024841:Fluoroquinolones; D004917:Erythromycin; D002443:Ceftriaxone; C057477:clinafloxacin