Randomized, open-label, parallel-group, multicenter study of the efficacy and tolerability of IV gatifloxacin with the option for oral stepdown gatifloxacin versus IV ceftriaxone (with or without erythromycin or clarithromycin) with the option for oral stepdown clarithromycin for treatment of patients with mild to moderate community-acquired pneumonia requiring hospitalization.
BACKGROUND
Empiric therapy for community-acquired pneumonia (CAP) requires the use of antibiotics with activity against a broad spectrum of respiratory pathogens and suitable pharmacokinetic properties to simplify IV-to-oral step-down therapy switches.


OBJECTIVE
The aim of this study was to compare the efficacy and tolerability of IV gatifloxacin with the option for oral stepdown gatifloxacin with a standard regimen of IV ceftriaxone (with or without erythromycin or clarithromycin) with the option for oral stepdown clarithromycin in patients with mild to moderate CAP requiring hospitalization.


METHODS
In a randomized, open-label, parallel-group, multicenter study, adults with CAP received 7 to 14 days of treatment with either IV gatifloxacin 400 mg QD with the stepdown option or IV ceftriaxone 1 or 2 g QD (with or without erythromycin 0.5 or 1 g QID or clarithromycin 500 mg BID) with the stepdown option.


RESULTS
One hundred seventy adults with CAP were included in the study. IV gatifloxacin was stepped down to oral gatifloxacin in 90.6% (7785) of patients; IV ceftriaxone was stepped down to oral clarithromycin in 87.1% (7485) of patients. Among clinically evaluable patients (n = 153), cure rates at 1 to 3 days after treatment were 97.4% in the gatifloxacin group (7476) and 90.9% in the ceftriaxone group (7077), with a 95% CI for the difference (-3.7% to 19.1%) indicating statistical equivalence. In patients in whom pathogens were isolated from pretreatment sputum cultures, bacteriologic eradication rates were 100.0% (2929) and 90.9% (3033), respectively. Both regimens were well tolerated; treatment-related adverse events occurred in 27.1% (2385) and 21.2% (1885) of patients, respectively.


CONCLUSIONS
In the population studied, treatment with IV gatifloxacin with an option for oral stepdown gatifloxacin was as effective for achieving clinical cure as IV ceftriaxone (with or without concomitant IV erythromycin or clarithromycin) with an option for oral stepdown clarithromycin. Both regimens were well tolerated.
Corrêa
João Carlos
JC
Hospital da Venerável Ordem Terceira de São Francisco da Penitência, Rio de Janeiro, Brazil. MedicData@msn.com
Badaró
Roberto
R
Bumroongkit
Chaiwat
C
Mera
Jorge Raúl
JR
Dolmann
Alberto Lorenzo
AL
Juárez Martínez
Luis Guillermo
LG
Mayrinck
Lusane Romero
LR
Tamez
Ricardo
R
Yang
Joanna Y
JY
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002443:Ceftriaxone / Q000008:administration & dosage / Q000627:therapeutic use*; D017291:Clarithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D017714:Community-Acquired Infections / Q000188:drug therapy*; D004917:Erythromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D024841:Fluoroquinolones; D000077734:Gatifloxacin; D006760:Hospitalization; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D011014:Pneumonia / Q000188:drug therapy* / Q000382:microbiology
D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D004917:Erythromycin; D002443:Ceftriaxone; D017291:Clarithromycin; D000077734:Gatifloxacin