amoxicillin-potassium-clavulanate-combination and Lung-Diseases--Obstructive

This randomized, double-blind study evaluated the efficacy and safety of a short, 5-day course of telithromycin, a new ketolide antibacterial, compared with a standard 10-day course of amoxicillin/clavulanate, in the treatment of acute exacerbations of chronic bronchitis (AECB). The study enrolled 325 adult patients with AECB and a history of chronic obstructive pulmonary disease (COPD). Patients received either telithromycin 800 mg once daily (qd) for 5 days (followed by placebo for 5 days) or amoxicillin/clavulanate 500/125 mg three times daily (tid) for 10 days. Clinical cure rates for telithromycin post-therapy (Days 17-21, test-of-cure) and late post-therapy (Days 31-36) were 86.1 and 78.1%, respectively; 82.1 and 75.0% for amoxicillin/clavulanate. Excellent clinical cure rates were also observed for high-risk patients. Bacteriologic outcome was satisfactory for 69.2% of telithromycin recipients vs 70.0% for amoxicillin/clavulanate recipients. Both treatments were generally well tolerated, although the frequency of drug-related adverse events was almost two-fold higher for amoxicillin/clavulanate (25.0 vs. 13.1%). Thus, a 5-day course of telithromycin 800 mg qd is an effective and well-tolerated alternative to a standard 10-day course of amoxicillin/clavulanate 500/125 mg tid for first-line empiric treatment of AECB in adults with COPD.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bronchitis, Chronic; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Ketolides; Lung Diseases, Obstructive; Macrolides; Male; Middle Aged; Treatment Outcome

The study was designed to extend retrospectively the analysis of a previously reported study on chronic bronchitis patients with acute exacerbations treated with amoxicillin-clavulanic acid or matched placebo. We retrospectively re-clustered patients on the basis of severity of baseline lung function: Cluster 1 (104 patients) mean screening FEV(1)32.67+/-6.83 (SD); Cluster 2 (109 patients) mean screening FEV(1)54.12+/-5.56; Cluster 3 (122 patients) mean screening FEV(1)71.54+/-5.51. The success rate in the antibiotic group was significantly greater compared to the placebo group (P<0.001). When clinical improvement was analysed on the basis of patient re-clustering, 31.4% of Cluster 1 (severe COPD) patients treated with amoxicillin/clavulanate showed clinical improvement, whereas success was recorded in 58.8%. Conversely, 13.2% of Cluster 1 patients receiving placebo improved and 17% successfully recovered (P<0.001). Mild and moderate COPD patients (Clusters 2 and 3) were grouped together. In these two groups, 31.2% and 53.6% of patients receiving antibiotic treatment showed improvement or recovery, respectively, compared to 29.2% improvements and 30.2% successful recoveries among placebo-treated patients (P<0.001). In placebo-treated patients the improvement/success vs. failure rate was significantly different in Cluster 1 patients compared to Cluster 2+3 subjects (P<0.01, (2)test). The differences in final FEV(1)values in the treatment group and placebo group were significantly different (P<0.01) in favour of the active treatment group. Among more severe patients (Cluster 1), the comparison between screening and follow up FEV(1)values showed an improvement following antibiotic treatment and worsening after placebo (P<0.01). In Clusters 2 and 3 the difference between screening and follow up FEV(1)values was not significant for both treatment groups. Our patients with severe functional impairment and higher number of exacerbations per year are those who derive the greatest benefit from antibiotic treatment.

Topics: Aged; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Chronic Disease; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Retrospective Studies; Severity of Illness Index

Exacerbations of chronic obstructive pulmonary disease (COPD) have an inflammatory component in addition to the possible infectious component. The antiinflammatory properties of fenspiride (Pneumorel(R) 80 mg) should be evaluated in this frequent clinical situation.. Assess the supplementary therapeutic benefit provided by fenspiride administered in combination with antibiotics in COPD patients presenting an episode of bronchial infection.. A preliminary randomized placebo-controlled double-blind study was conduced in 7 centers. Patients under 80 years of age of both sexes were included. All patients had COPD and presented a bronchial infection defined as the presence of at least 2 of the 3 criteria defined by Anthonisen. Patients were randomly assigned to group F or group P. Group F received an antibiotic therapy from day 1 to day 11 plus fenspiride (3 x 80mg/d from day 0 to day 30). Group P received the same antibiotic therapy plus placebo. Amoxicillin 500mg plus clavulanic acid 125, 3 tablets/day, was administered in both groups.. Thirty-nine patients were included (group F 19 patients, group P 20 patients; 6 women and 33 men; mean age 61.1 +/- 9.8 years). The 3 Anthonisen criteria were present in 79% and 75% of the patients in group F and P respectively (NS). On day 11, expectoration resolved in 39% and 32% (NS) and cough in 44% and 16% (NS) of the patients in groups F and P respectively. Lung auscultation returned to normal in 83% of the patients in group F compared with 47% in group P (p=0.05). A composite clinical score including expectoration cough and auscultation findings showed that 28% of the patients in group F were symptom-free on day 11 compared with 0% in group P (p=0.04). On day 30, the two groups were comparable.. In this preliminary study of patients with COPD presenting a bronchial superinfection, there was a significant improvement in lung auscultation and in the composite clinical score in patients given fenspiride. Fenspiride was thus found to provide an early clinical benefit.

Topics: Acute Disease; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bronchitis; Bronchodilator Agents; Combined Modality Therapy; Cyclooxygenase Inhibitors; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Prospective Studies; Spiro Compounds; Treatment Outcome

In a double-blind, placebo-controlled trial, patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) were randomly allocated to oral treatment with sparfloxacin (200 mg loading dose followed by 100 mg once daily) or amoxycillin/clavulanic acid (500 mg/125 mg tds) for a total treatment duration of 7 to 14 days. Patients were evaluable if they had a FEV1/FVC ratio of less than 70% at stable state and presented with a suspected infectious exacerbation defined as increases in dyspnoea, sputum volume and sputum purulence. The primary efficacy variable was the overall success (defined as disappearance or improvement of dyspnoea and reductions in sputum volume and purulence) at end of treatment and follow-up. Overall efficacy was assessed in both the intent-to-treat (728 patients) and the evaluable (351 patients) populations. At the end of treatment and follow-up, success rates were identical for the sparfloxacin (87.3% and 78.7%) and amoxycillin-clavulanic acid (88.8% and 79.8%) treatment groups. Similar figures were found for the intent-to-treat population. The analysis of drug safety was similar for both treatment groups. The most frequently encountered pathogens were Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Sparfloxacin appeared superior for bacteriological eradication of Haemophilus influenzae, and Moraxella catarrhalis. Sparfloxacin in a single daily dose appears at least as effective as amoxycillin/clavulanic acid in the treatment of patients with acute exacerbations of COPD.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Fluoroquinolones; Haemophilus influenzae; Humans; Lung Diseases, Obstructive; Middle Aged; Moraxella catarrhalis; Quinolones; Streptococcus pneumoniae

Antibiotic therapy for acute episodes of chronic obstructive pulmonary disease (COPD) is a controversial issue still not clarified. In order to evaluate the effectivity of the antibiotic therapy, we designed a double-blind controlled and randomized clinical trial, in which 90 patients hospitalized due to an acute episode of COPD were divided into three groups: group I, cotrimoxazole (29 patients); group II, amoxicillin-clavulanic acid (32 patients) and group III, placebo (29 patients). Gasometric and spirometric measures were taken in addition to clinical evaluation at hospital admission and discharge using a numerical valoration system. All patients were treated with common bronchodilators. The three groups were homogeneous at their admission and there were no statistical differences at their discharge. We conclude that antibiotics do not play a relevant role in the improvement of acute episodes of COPD.

Topics: Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Trimethoprim, Sulfamethoxazole Drug Combination

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Cefuroxime; Chi-Square Distribution; Chronic Disease; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Israel; Lung Diseases, Obstructive; Male; Middle Aged; Single-Blind Method

The objective of this report was to document the pattern of initial antibiotic prescribing in acute exacerbations of chronic obstructive pulmonary disease (COPD) in a hospital setting. All episodes of acute exacerbation of COPD, as diagnosed by the admitting doctor, in one hospital in the period January to May 1996, were identified. Case notes were reviewed retrospectively. Cases of radiographic pneumonia, bronchiectasis and incorrectly coded admissions were excluded. Symptoms, microbial cultures and initial antibiotic therapies were recorded. One hundred and fifty-nine patient episodes were identified; 40 were excluded yielding a sample of 119. Nineteen case notes were unavailable leaving a sample of 100 (84%) episodes. Eighty were treated with antibiotics on admission; amoxycillin was the most frequently prescribed, in 46 (58%) episodes. Of the antibiotic treated group, 42 (53%) patients were given dual therapy, most commonly a macrolide antibiotic with either amoxycillin or a cephalosporin. Intravenous treatment was used in 22 (28%) cases. The duration of intravenous treatment was >48 h in 12 (15%) cases. A total of 76 sputum samples were analysed from 55 patient episodes: 34 (45%) were culture positive. In 15 (27%) patient episodes, antibiotic therapy was changed or instituted on the basis of culture results. These data suggest that antibiotic treatment is not optimal, with overuse of antibiotics, especially intravenous and dual therapy.

Topics: Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Case-Control Studies; Drug Therapy, Combination; Drug Utilization Review; Female; Humans; Lung Diseases, Obstructive; Male; Penicillins; Retrospective Studies; Tetracycline

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria, Anaerobic; Bacterial Infections; Community-Acquired Infections; Drug Therapy, Combination; Empyema, Pleural; Humans; Lung Abscess; Lung Diseases, Obstructive; Microbial Sensitivity Tests; Pleurisy; Pneumonia, Bacterial; Respiratory Tract Infections

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Cefixime; Cefotaxime; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Respiratory Tract Infections; Sputum

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acids; Drug Therapy, Combination; Haemophilus influenzae; Humans; Lung Diseases, Obstructive; Microbial Sensitivity Tests; Moraxella catarrhalis; Streptococcus pneumoniae