PMID- 12240780
OWN - NLM
STAT- MEDLINE
DCOM- 20030312
LR  - 20190922
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 24
IP  - 8
DP  - 2002 Aug
TI  - A multicenter, open-label, randomized comparison of levofloxacin and azithromycin 
      plus ceftriaxone in hospitalized adults with moderate to severe 
      community-acquired pneumonia.
PG  - 1292-308
AB  - BACKGROUND: Changing etiologic patterns and the growing problem of antimicrobial 
      resistance, particularly an increase in macrolide-resistant pneumococcal 
      bacteremia, are causing physicians to adopt new approaches to the treatment of 
      community-acquired pneumonia (CAP). OBJECTIVE: The relative efficacy and 
      tolerability of levofloxacin monotherapy and azithromycin and ceftriaxone 
      combination therapy were assessed in hospitalized adults with moderate to severe 
      CAP. METHODS: This Phase IV, multicenter, open-label, randomized trial compared 2 
      treatment regimens: (1) levofloxacin 500 mg PO or IV q24h, and (2) azithromycin 
      500 mg IV q24h for > or = 2 days plus ceftriaxone 1 g IV q24h for 2 days, 
      followed by an optional transition to azithromycin 500 mg PO q24h at the 
      investigator's discretion. The total duration of therapy was to be a minimum of 
      10 days in both treatment groups. Ceftriaxone was included in the initial 
      azithromycin regimen to ensure coverage against pneumococcal bacteremia. RESULTS: 
      Of 236 patients in the intent-to-treat population, completion or withdrawal 
      information was available for 110 patients in the levofloxacin group and 114 in 
      the azithromycin group. Baseline demographic and disease characteristics were 
      comparable between groups. At the end of treatment, the clinical success rate 
      (cured + improved) in clinically evaluable patients was 94.1% in the levofloxacin 
      group and 92.3% in the azithromycin group. The respective posttherapy 
      microbiologic eradication rates were 89.5% and 92.3%. Levofloxacin was as well 
      tolerated as azithromycin, with an incidence of drug-related adverse events (AEs) 
      for all body systems of 5.3% and 9.3%, respectively. None of the drug-related AEs 
      were considered serious [corrected]. CONCLUSIONS: In this study in hospitalized 
      patients with moderate to severe CAP, levofloxacin monotherapy was at least as 
      effective as a combination regimen of azithromycin and ceftriaxone in providing 
      coverage against the current causative pathogens in CAP. In addition, 
      levofloxacin was as well tolerated as the combination of azithromycin and 
      ceftriaxone.
FAU - Frank, Elliott
AU  - Frank E
AD  - Jersey Shore Medical Center, Neptune, New Jersey, USA.
FAU - Liu, Jing
AU  - Liu J
FAU - Kinasewitz, Gary
AU  - Kinasewitz G
FAU - Moran, Gregory J
AU  - Moran GJ
FAU - Oross, Margaret P
AU  - Oross MP
FAU - Olson, William H
AU  - Olson WH
FAU - Reichl, Veronica
AU  - Reichl V
FAU - Freitag, Susan
AU  - Freitag S
FAU - Bahal, Neelam
AU  - Bahal N
FAU - Wiesinger, Barbara A
AU  - Wiesinger BA
FAU - Tennenberg, Alan
AU  - Tennenberg A
FAU - Kahn, James B
AU  - Kahn JB
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 6GNT3Y5LMF (Levofloxacin)
RN  - 75J73V1629 (Ceftriaxone)
RN  - 83905-01-5 (Azithromycin)
RN  - A4P49JAZ9H (Ofloxacin)
SB  - IM
EIN - Clin Ther. 2003 Mar;25(3):1039
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Azithromycin/administration & dosage/adverse effects/*therapeutic use
MH  - Ceftriaxone/administration & dosage/adverse effects/*therapeutic use
MH  - Community-Acquired Infections/classification/*drug therapy
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - *Levofloxacin
MH  - Male
MH  - Middle Aged
MH  - Ofloxacin/administration & dosage/adverse effects/*therapeutic use
MH  - Pneumonia/classification/*drug therapy
MH  - Severity of Illness Index
EDAT- 2002/09/21 10:00
MHDA- 2003/03/13 04:00
CRDT- 2002/09/21 10:00
PHST- 2002/09/21 10:00 [pubmed]
PHST- 2003/03/13 04:00 [medline]
PHST- 2002/09/21 10:00 [entrez]
AID - S0149-2918(02)80034-0 [pii]
AID - 10.1016/s0149-2918(02)80034-0 [doi]
PST - ppublish
SO  - Clin Ther. 2002 Aug;24(8):1292-308. doi: 10.1016/s0149-2918(02)80034-0.