ABSTRACT
Antibiotic therapy is of clinical benefit in certain patients with acute exacerbations of chronic bronchitis (AECB). In this randomised, investigator-blinded, multicentre trial, azithromycin (500mg once a day (qd) for 3 days) was compared with moxifloxacin (400mg qd for 5 days) for the treatment of outpatients with AECB (forced expiratory volume in 1s (FEV(1)) >35%). Of 342 patients randomised to either treatment, 169 received azithromycin and 173 received moxifloxacin. The mean age in the azithromycin and moxifloxacin groups was 56.4 years and 55.5 years, respectively. In the intent-to-treat analysis, clinical success rates for azithromycin and moxifloxacin were comparable at Days 10-12 (90% versus 90%, respectively) and Days 22-26 (81% versus 82%, respectively). Among patients who were culture-positive at baseline for Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis or Haemophilus parainfluenzae, clinical efficacy for azithromycin versus moxifloxacin at Days 10-12 was 93% versus 84%, respectively, and at Days 22-26 it was 89% versus 73%, respectively. The incidence of at least one treatment-related adverse event (AE) in the azithromycin and moxifloxacin groups was 18.3% and 19.1%, respectively. The most common AEs were diarrhoea, nausea, abdominal pain and vaginitis. Most treatment-related AEs were of mild or moderate severity, with no serious treatment-related AEs. One subject in the moxifloxacin group discontinued treatment owing to a treatment-related AE (precordial pain and dry throat). Compliance with both regimens was >90%. Three-day azithromycin and 5-day moxifloxacin demonstrate comparable efficacy and safety for the treatment of AECB in outpatients.
Subject(s)
Aza Compounds/therapeutic use , Azithromycin/therapeutic use , Bronchitis, Chronic/drug therapy , Quinolines/therapeutic use , Abdominal Pain/chemically induced , Adult , Aged , Anti-Bacterial Agents/adverse effects , Anti-Bacterial Agents/pharmacology , Anti-Bacterial Agents/therapeutic use , Aza Compounds/adverse effects , Aza Compounds/pharmacology , Azithromycin/adverse effects , Azithromycin/pharmacology , Bronchitis, Chronic/microbiology , Drug Administration Schedule , Female , Fluoroquinolones , Haemophilus influenzae/drug effects , Haemophilus influenzae/isolation & purification , Haemophilus parainfluenzae/drug effects , Haemophilus parainfluenzae/isolation & purification , Humans , Male , Microbial Sensitivity Tests , Middle Aged , Moraxella catarrhalis/drug effects , Moraxella catarrhalis/isolation & purification , Moxifloxacin , Nausea/chemically induced , Patient Compliance , Quinolines/adverse effects , Quinolines/pharmacology , Single-Blind Method , Streptococcus pneumoniae/drug effects , Streptococcus pneumoniae/isolation & purification , Treatment Outcome , Vaginitis/chemically inducedABSTRACT
STUDY OBJECTIVES: To compare the safety and efficacy of oral azithromycin and levofloxacin in the treatment of outpatients with acute bacterial exacerbations of chronic bronchitis (ABECB). DESIGN: Randomized, double-blinded, double-dummy, multicenter trial with 1:1 treatment allocation. SETTING: Outpatient treatment setting. PATIENTS: Two hundred thirty-five male or female outpatients between the ages of 35 and 75 years who had received a clinical diagnosis of ABECB. INTERVENTIONS: Blinded treatment with either oral azithromycin, 500 mg on day 1 and 250 mg per day for days 2 to 5, or, oral levofloxacin, 500 mg q24h for 7 days. RESULTS: Both treatments were well-tolerated, with the majority of adverse events being GI in nature. Favorable clinical outcomes in clinically evaluable patients were demonstrated in 89% of patients receiving azithromycin and in 92% of patients receiving levofloxacin by day 4 of therapy. At day 24, the posttherapy visit, favorable responses were approximately 82% and 86%, respectively, for patients in the two treatment groups. The bacterial eradication rates of respiratory pathogens were 96% for azithromycin and 85% for levofloxacin. CONCLUSIONS: Despite increasing concerns over macrolide resistance and a higher incidence of Gram-negative pathogens, a standard 5-day course of oral azithromycin was clinically and bacteriologically equivalent to a 7-day course of oral levofloxacin in the treatment of patients with ABECB.
Subject(s)
Anti-Bacterial Agents/therapeutic use , Anti-Infective Agents/therapeutic use , Azithromycin/therapeutic use , Bacterial Infections/drug therapy , Bronchitis, Chronic/microbiology , Levofloxacin , Ofloxacin/therapeutic use , Acute Disease , Adult , Aged , Double-Blind Method , Female , Humans , Logistic Models , Male , Middle Aged , Multivariate AnalysisABSTRACT
The comparative safety of azithromycin was assessed in adult patients (> or =12 years) with community-acquired respiratory tract infections. Of 3229 patients evaluated, 1616 received azithromycin 500 mg once daily for 3 days and 1613 received standard regimens of amoxycillin, amoxycillin/clavulanic acid, cefaclor, clarithromycin, or roxithromycin. A similar incidence of treatment-related adverse events occurred with azithromycin (10.3%) and comparators (11.5%). Significantly fewer patients were withdrawn from azithromycin than comparator treatment (0.4 versus 2.1%; P=0.0001). Most adverse events were mild/moderate in intensity and affected the gastrointestinal system. Azithromycin was as well tolerated as other antibiotics commonly used for bacterial infections in adults.
