Sparfloxacin vs ofloxacin in the treatment of acute bacterial exacerbations of chronic bronchitis: a multicenter, double-blind, randomized, comparative study. Sparfloxacin Multicenter ABECB Study Group.
OBJECTIVE
Comparison of efficacy and safety of sparfloxacin vs ofloxacin for treatment of acute bacterial exacerbations of chronic bronchitis (ABECB).


METHODS
Multicenter, double-blind, randomized study.


METHODS
Sixty-eight private offices and outpatient clinics in the United States and Canada.


METHODS
Seven hundred ninety-eight adults with ABECB, as confirmed by the acute onset of new (or worsened from the immediate premorbid state) cough and sputum production.


METHODS
Randomization 1:1 to sparfloxacin, 400 mg on day 1, then 200 mg once daily, or ofloxacin, 400 mg twice daily, with matching comparator placebos, given concurrently for 10 consecutive days.


RESULTS
The primary efficacy parameter was overall response in the bacteriologically evaluable population. Overall success rates in this population were 85.3% and 89.3% for sparfloxacin and ofloxacin, respectively. The two-sided 95% confidence interval was -9.9, 1.9, indicating that sparfloxacin was statistically equivalent to ofloxacin. The all-treated population analysis was similar to that in the evaluable population. Bacterial eradication rates were similar in both treatment groups for Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Enterobacter cloacae, and Staphylococcus aureus. The frequency of adverse events overall was comparable in the two treatment groups. The sparfloxacin group had a lower frequency of digestive and nervous system adverse events, but a higher frequency of photosensitivity reactions than the ofloxacin group.


CONCLUSIONS
Once-daily oral treatment with 200 mg sparfloxacin (after initial 400 mg dose) is as effective as twice-daily treatment with 400 mg ofloxacin in patients with ABECB.
DeAbate
C A
CA
Medical Research Center, New Orleans, USA.
Henry
D
D
Bensch
G
G
Jubran
A
A
Chodosh
S
S
Harper
L
L
Tipping
D
D
Talbot
G H
GH
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D001991:Bronchitis / Q000188:drug therapy / Q000382:microbiology*; D002690:Chlamydia Infections / Q000188:drug therapy; D016993:Chlamydophila pneumoniae / Q000187:drug effects; D002908:Chronic Disease; D003371:Cough / Q000188:drug therapy; D004311:Double-Blind Method; D016972:Enterobacter cloacae / Q000187:drug effects; D004756:Enterobacteriaceae Infections / Q000188:drug therapy; D005260:Female; D024841:Fluoroquinolones; D006192:Haemophilus Infections / Q000188:drug therapy; D006193:Haemophilus influenzae / Q000187:drug effects; D006801:Humans; D007710:Klebsiella Infections / Q000188:drug therapy; D007711:Klebsiella pneumoniae / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D001936:Moraxella catarrhalis / Q000187:drug effects; D016870:Neisseriaceae Infections / Q000188:drug therapy; D015242:Ofloxacin / Q000627:therapeutic use*; D010919:Placebos; D011008:Pneumococcal Infections / Q000188:drug therapy; D015363:Quinolones / Q000627:therapeutic use*; D013183:Sputum / Q000187:drug effects; D013203:Staphylococcal Infections / Q000188:drug therapy; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D010919:Placebos; D015363:Quinolones; D015242:Ofloxacin; C061363:sparfloxacin