Randomised double-blind comparison of oral gatifloxacin and co-amoxiclav for acute exacerbation of chronic Bronchitis.

Abstract

Antimicrobial therapy can have a significant impact in the treatment of acute infectious exacerbations in patients with chronic bronchitis, in whom repeated episodes are common. The aim of this randomised, double-blind, double-dummy, parallel group study was to compare the efficacy and safety of oral gatifloxacin (200 and 400 mg once daily) administered for 5 days with co-amoxiclav (500 mg amoxicillin/125 mg clavulanic acid t.i.d.) administered for 10 days in 414 adult patients with acute exacerbation of chronic bronchitis. Overall clinical response rates (cure plus improvement) were 86.2%, 79.4% and 81.7% in the gatifloxacin 200 mg, gatifloxacin 400 mg and co-amoxiclav groups, respectively, and the equivalence hypothesis used for statistical analysis showed equivalent efficacy for both gatifloxacin 200 and 400 mg compared to co-amoxiclav. The same was true for rates of bacterial response, with eradication or presumed eradication of causative pathogens achieved in 87.5%, 87.3% and 79.1% of cases in the gatifloxacin 200 mg, gatifloxacin 400 mg and co-amoxiclav groups, respectively. All treatments were well tolerated, with the nature and frequency of treatment-related adverse events similar in all groups. The results of the study show that gatifloxacin is a safe and effective agent for the treatment of patients with chronic bronchitis experiencing an acute infectious exacerbation.

• Authors: M Solèr, H Lode, R Baldwin, J H A Levine, A J M Schreurs, J A van Noord, F P V Maesen, M Zehrer, European Gatifloxacin Study group
• Journal: European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology (Eur J Clin Microbiol Infect Dis) Vol. 22 Issue 3 Pg. 144-50 (Mar 2003) ISSN: 0934-9723 [Print] Germany
• PMID: 12649711 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Infective Agents
• Fluoroquinolones
• Amoxicillin-Potassium Clavulanate Combination
• Gatifloxacin

Topics

• Administration, Oral
• Amoxicillin-Potassium Clavulanate Combination (administration & dosage, adverse effects, therapeutic use)
• Anti-Infective Agents (administration & dosage, adverse effects, therapeutic use)
• Bacteria (classification, isolation & purification)
• Bacterial Infections (drug therapy)
• Bronchitis, Chronic (drug therapy, microbiology)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Fluoroquinolones
• Gatifloxacin
• Humans
• Male
• Partial Pressure
• Treatment Outcome
• Vital Capacity