Efficacy and safety of tigecycline versus levofloxacin for community-acquired pneumonia.
BACKGROUND
Tigecycline, an expanded broad-spectrum glycylcycline, exhibits in vitro activity against many common pathogens associated with community-acquired pneumonia (CAP), as well as penetration into lung tissues that suggests effectiveness in hospitalized CAP patients. The aim of the present study was to compare the efficacy and safety of intravenous (IV) tigecycline with IV levofloxacin in hospitalized adults with CAP.


METHODS
In this prospective, double-blind, non-inferiority phase 3 trial, eligible patients with a clinical diagnosis of CAP supported by radiographic evidence were stratified by Fine Pneumonia Severity Index and randomized to tigecycline or levofloxacin for 7-14 days of therapy. Co-primary efficacy endpoints were clinical response in the clinically evaluable (CE) and clinical modified intent-to-treat (c-mITT) populations at test-of-cure (Day 10-21 post-therapy).


RESULTS
Of the 428 patients who received at least one dose of study drug, 79% had CAP of mild-moderate severity according to their Fine score. Clinical cure rates for the CE population were 88.9% for tigecycline and 85.3% for levofloxacin. Corresponding c-mITT population rates were 83.7% and 81.5%, respectively. Eradication rates for Streptococcus pneumoniae were 92% for tigecycline and 89% for levofloxacin. Nausea, vomiting, and diarrhoea were the most frequently reported adverse events. Rates of premature discontinuation of study drug or study withdrawal because of any adverse event were similar for both study drugs.


CONCLUSIONS
These findings suggest that IV tigecycline is non-inferior to IV levofloxacin and is generally well-tolerated in the treatment of hospitalized adults with CAP.


BACKGROUND
NCT00081575.
Tanaseanu
Cristina
C
St Pantelimon Clinical Emergency Hospital, Bucharest, Romania. cristina.tanaseanu@gmail.com
Milutinovic
Slobodan
S
Calistru
Petre I
PI
Strausz
Janos
J
Zolubas
Marius
M
Chernyak
Valeriy
V
Dartois
Nathalie
N
Castaing
Nathalie
N
Gandjini
Hassan
H
Cooper
C Angel
CA
D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D017714:Community-Acquired Infections / Q000188:drug therapy* / Q000382:microbiology; D003967:Diarrhea / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D008911:Minocycline / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D009325:Nausea / Q000139:chemically induced; D015242:Ofloxacin / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D018410:Pneumonia, Bacterial / Q000188:drug therapy*; D011446:Prospective Studies; D012720:Severity of Illness Index; D000078304:Tigecycline; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced; D055815:Young Adult
D000900:Anti-Bacterial Agents; D064704:Levofloxacin; D000078304:Tigecycline; D015242:Ofloxacin; D008911:Minocycline