PMID- 11911557
OWN - NLM
STAT- MEDLINE
DCOM- 20020913
LR  - 20190922
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 24
IP  - 2
DP  - 2002 Feb
TI  - A multicenter, randomized, investigator-blinded study of 5- and 10-day 
      gatifloxacin versus 10-day amoxicillin/clavulanate in patients with acute 
      bacterial sinusitis.
PG  - 269-81
AB  - BACKGROUND: Treatment guidelines for acute bacterial sinusitis recommend 10 to 14 
      days of therapy with amoxicillin/clavulanate, high-dose amoxicillin, cefpodoxime, 
      cefuroxime, or a newer fluoroquinolone. OBJECTIVE: This study compared the 
      clinical efficacy of short-course (5-day) gatifloxacin with standard 10-day 
      regimens of amoxicillin/clavulanate or gatifloxacin in patients with a diagnosis 
      of acute, uncomplicated maxillary sinusitis. METHODS: This was a multicenter, 
      investigator-blinded study in adult patients (age >18 years) with physical 
      findings, signs and symptoms (for at least 7 days), and radiographic findings 
      indicating acute, uncomplicated maxillary sinusitis. Patients were randomized to 
      receive gatifloxacin 400 mg once daily for 5 days, gatifloxacin 400 mg once daily 
      for 10 days, or amoxicillin/clavulanate 875 mg twice daily for 10 days. Clinical 
      response was assessed once between days 3 and 5 of treatment, once I to 3 days 
      after the completion of study treatment, once 7 to 14 days posttreatment 
      (test-of-cure visit), and once 21 to 28 days posttreatment. Safety was assessed 
      throughout the study. RESULTS: The study enrolled 445 patients. The treatment 
      groups were similar in terms of history of sinusitis, presenting signs and 
      symptoms, and radiographic findings. The most common presenting symptoms were 
      nasal congestion, sinus tenderness, and purulent nasal discharge (>90% of 
      patients); 99% of patients had abnormal radiographic findings. At the 
      test-of-cure visit, clinical cure rates for clinically evaluable patients in the 
      3 treatment groups were 74% (102/137) for 5-day gatifloxacin, 80% (101/127) for 
      10-day gatifloxacin, and 72% (101/ 141) for 10-day amoxicillin/clavulanate (95% 
      CI for the difference in cure rates: 5-day gatifloxacin vs 
      amoxicillin/clavulanate, -7.6 to 13.2; 5- vs 10-day gatifloxacin, -15.2 to 5.1; 
      10-day gatifloxacin vs amoxicillin/clavulanate, -2.3 to 18.1). The distribution 
      and incidence of drug-related adverse events (AEs) were comparable between 
      treatment groups, and the majority (>95%) were mild or moderate in severity. The 
      most common drug-related AEs included vaginitis, diarrhea, and nausea. 
      CONCLUSION: In this population of patients with acute, uncomplicated sinusitis of 
      presumed bacterial origin, a short course (5 days) of gatifloxacin therapy was 
      associated with comparable clinical cure rates and tolerability to those of 
      standard 10-day therapy with gatifloxacin or amoxicillin/clavulanate.
FAU - Sher, Lawrence D
AU  - Sher LD
AD  - Peninsula Research Associates, Rolling Hills Estates, California 90274, USA. 
      L.Sher@verizon.net
FAU - McAdoo, Michael A
AU  - McAdoo MA
FAU - Bettis, Robert B
AU  - Bettis RB
FAU - Turner, Mark A
AU  - Turner MA
FAU - Li, Nicole F
AU  - Li NF
FAU - Pierce, Phillip F
AU  - Pierce PF
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Anti-Infective Agents)
RN  - 0 (Fluoroquinolones)
RN  - 74469-00-4 (Amoxicillin-Potassium Clavulanate Combination)
RN  - L4618BD7KJ (Gatifloxacin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Amoxicillin-Potassium Clavulanate Combination/adverse effects/*therapeutic use
MH  - Anti-Bacterial Agents/adverse effects/*therapeutic use
MH  - Anti-Infective Agents/adverse effects/*therapeutic use
MH  - Drug Therapy, Combination/adverse effects/*therapeutic use
MH  - Female
MH  - *Fluoroquinolones
MH  - Gatifloxacin
MH  - Humans
MH  - Male
MH  - Maxillary Sinusitis/*drug therapy
MH  - Middle Aged
MH  - Single-Blind Method
EDAT- 2002/03/26 10:00
MHDA- 2002/09/14 10:01
CRDT- 2002/03/26 10:00
PHST- 2002/03/26 10:00 [pubmed]
PHST- 2002/09/14 10:01 [medline]
PHST- 2002/03/26 10:00 [entrez]
AID - S0149-2918(02)85023-8 [pii]
AID - 10.1016/s0149-2918(02)85023-8 [doi]
PST - ppublish
SO  - Clin Ther. 2002 Feb;24(2):269-81. doi: 10.1016/s0149-2918(02)85023-8.