amoxicillin-potassium-clavulanate-combination and Bronchitis

Background. Mycoplasma pneumoniae (M. pneumoniae) is widely recognised as an important cause of community-acquired lower respiratory tract infection (LRTI) in children. Pulmonary manifestations are typically tracheobronchitis or pneumonia but M. pneumoniae is also implicated in wheezing episodes in both asthmatic and non-asthmatic individuals. Although antibiotics are used to treat LRTIs, are view of several major textbooks offers conflicting advice for using antibiotics in the management of M. pneumoniae LRTI in children.Objectives To determine whether antibiotics are effective in the treatment of childhood LRTI secondary to M. pneumoniae infections acquired in the community.Search methods We searched CENTRAL (2014, Issue 3), MEDLINE (1966 to July week 4, 2014), EMBASE (1980 to July, 2014), and both WHOICTRP and ClinicalTrials.gov (13 August 2014).Selection criteria Randomised controlled trials (RCTs) comparing antibiotics commonly used for treating M. pneumoniae (i.e. macrolide, tetracycline or quinolone classes) versus placebo, or antibiotics from any other class in the treatment of children under 18 years of age with community acquired LRTI secondary to M. pneumoniae.Data collection and analysis The review authors independently selected trials for inclusion and assessed methodological quality. We extracted and analysed relevant data separately and resolved disagreements by consensus.Main results A total of 1912 children were enrolled from seven studies. Data interpretation was limited by the inability to extract data that referred to children with M. pneumoniae. In most studies, clinical response did not differ between children randomised to a macrolide antibiotic and children randomised to a non-macrolide antibiotic. In one controlled study (of children with recurrent respiratory infections, whose acute LRTI was associated with Mycoplasma, Chlamydia or both, by polymerase chain reaction and/or paired sera) 100% of children treated with azithromycin had clinical resolution of their illness compared to 77% not treated with azithromycin at one month. Authors' conclusions There is insufficient evidence to draw any specific conclusions about the efficacy of antibiotics for this condition in children (although one trial suggests macrolides may be efficacious in some children with LRTI secondary to Mycoplasma). The use of antibiotics has to be balanced with possible adverse events. There is still a need for high quality, double-blinded RCTs to assess the ef

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Bronchitis; Child; Community-Acquired Infections; Erythromycin; Humans; Mycoplasma pneumoniae; Pneumonia, Mycoplasma; Randomized Controlled Trials as Topic

Acute lower respiratory tract infections (LRTI) range from acute bronchitis and acute exacerbations of chronic bronchitis to pneumonia. Approximately five million people die from acute respiratory tract infections annually. Among these, pneumonia represents the most frequent cause of mortality, hospitalisation and medical consultation. Azithromycin is a macrolide antibiotic, structurally modified from erythromycin and noted for its activity against some gram-negative organisms associated with respiratory tract infections, particularly Haemophilus influenzae (H. influenzae).. To compare the effectiveness of azithromycin to amoxycillin or amoxycillin/clavulanic acid (amoxyclav) in the treatment of LRTI, in terms of clinical failure, incidence of adverse events and microbial eradication.. We searched CENTRAL (2014, Issue 10), MEDLINE (January 1966 to October week 4, 2014) and EMBASE (January 1974 to November 2014).. Randomised controlled trials (RCTs) and quasi-RCTs, comparing azithromycin to amoxycillin or amoxycillin/clavulanic acid in participants with clinical evidence of an acute LRTI, such as acute bronchitis, pneumonia and acute exacerbation of chronic bronchitis.. The review authors independently assessed all potential studies identified from the searches for methodological quality. We extracted and analysed relevant data separately. We resolved discrepancies through discussion. We initially pooled all types of acute LRTI in the meta-analyses. We investigated the heterogeneity of results using the forest plot and Chi(2) test. We also used the index of the I(2) statistic to measure inconsistent results among trials. We conducted subgroup and sensitivity analyses.. We included 16 trials involving 2648 participants. We were able to analyse 15 of the trials with 2496 participants. The pooled analysis of all the trials showed that there was no significant difference in the incidence of clinical failure on about days 10 to 14 between the two groups (risk ratio (RR), random-effects 1.09; 95% confidence interval (CI) 0.64 to 1.85). A subgroup analysis in trials with acute bronchitis participants showed significantly lower clinical failure in the azithromycin group compared to amoxycillin or amoxyclav (RR random-effects 0.63; 95% CI 0.45 to 0.88). A sensitivity analysis showed a non-significant reduction in clinical failure in azithromycin-treated participants (RR 0.55; 95% CI 0.25 to 1.21) in three adequately concealed studies, compared to RR 1.32; 95% CI 0.70 to 2.49 in 12 studies with inadequate concealment. Twelve trials reported the incidence of microbial eradication and there was no significant difference between the two groups (RR 0.95; 95% CI 0.87 to 1.03). The reduction of adverse events in the azithromycin group was RR 0.76 (95% CI 0.57 to 1.00).. There is unclear evidence that azithromycin is superior to amoxycillin or amoxyclav in treating acute LRTI. In patients with acute bronchitis of a suspected bacterial cause, azithromycin tends to be more effective in terms of lower incidence of treatment failure and adverse events than amoxycillin or amoxyclav. However, most studies were of unclear methodological quality and had small sample sizes; future trials of high methodological quality and adequate sizes are needed.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Bronchitis; Drug Therapy, Combination; Humans; Pneumonia; Randomized Controlled Trials as Topic; Respiratory Tract Infections; Treatment Failure

Mycoplasma pneumoniae (M. pneumoniae) is widely recognised as an important cause of community-acquired lower respiratory tract infection (LRTI) in children. Pulmonary manifestations are typically tracheobronchitis or pneumonia but M. pneumoniae is also implicated in wheezing episodes in both asthmatic and non-asthmatic individuals. Although antibiotics are used to treat LRTIs, a review of several major textbooks offers conflicting advice for using antibiotics in the management of M. pneumoniae LRTI in children.. To determine whether antibiotics are effective in the treatment of childhood LRTI secondary to M. pneumoniae infections acquired in the community.. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 2), which contains the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1966 to February week 5, 2012) and EMBASE (1980 to March 2012).. Randomised controlled trials (RCTs) comparing antibiotics commonly used for treating M. pneumoniae (i.e. macrolide, tetracycline or quinolone classes) versus placebo, or antibiotics from any other class in the treatment of children under 18 years of age with community-acquired LRTI secondary to M. pneumoniae.. The review authors independently selected trials for inclusion and assessed methodological quality. We extracted and analysed relevant data separately. We resolved disagreements by consensus.. A total of 1912 children were enrolled from seven studies. Data interpretation was limited by the inability to extract data that referred to children with M. pneumoniae. In most studies, clinical response did not differ between children randomised to a macrolide antibiotic and children randomised to a non-macrolide antibiotic. In one controlled study (of children with recurrent respiratory infections, whose acute LRTI was associated with Mycoplasma, Chlamydia or both by polymerase chain reaction, and/or paired sera) 100% of children treated with azithromycin had clinical resolution of their illness compared to 77% not treated with azithromycin at one month.. There is insufficient evidence to draw any specific conclusions about the efficacy of antibiotics for this condition in children (although one trial suggests macrolides may be efficacious in some children with LRTI secondary to Mycoplasma). The use of antibiotics has to be balanced with possible adverse events. There is still a need for high quality, double-blinded RCTs to assess the efficacy and safety of antibiotics for LRTI secondary to M. pneumoniae in children.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Bronchitis; Child; Community-Acquired Infections; Erythromycin; Humans; Mycoplasma pneumoniae; Pneumonia, Mycoplasma; Randomized Controlled Trials as Topic

Acute lower respiratory tract infections (LRTI) range from acute bronchitis and acute exacerbations of chronic bronchitis to pneumonia. Approximately five million people die of acute respiratory tract infections annually. Among these, pneumonia represents the most frequent cause of mortality, hospitalization and medical consultation. Azithromycin is a new macrolide antibiotic, structurally modified from erythromycin and noted for its activity against some gram-negative organisms associated with respiratory tract infections, particularly Haemophilus influenzae (H. influenzae).. To compare the effectiveness of azithromycin to amoxycillin or amoxycillin/clavulanic acid (amoxyclav) in the treatment of LRTI, in terms of clinical failure, incidence of adverse events and microbial eradication.. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007 Issue 2), MEDLINE (January 1966 to July 2007), and EMBASE (January 1974 to July 2007).. Randomized and quasi-randomized controlled trials, comparing azithromycin to amoxycillin or amoxycillin/clavulanic acid in participants with clinical evidence of acute LRTI: acute bronchitis, pneumonia, and acute exacerbation of chronic bronchitis were studied.. The criteria for assessing study quality were generation of allocation sequence, concealment of treatment allocation, blinding, and completeness of the trial. All types of acute LRTI were initially pooled in the meta-analyses. The heterogeneity of results was investigated by the forest plot and Chi-square test. Index of I-square (I(2)) was also used to measure inconsistent results among trials. Subgroup and sensitivity analyses were conducted.. Fifteen trials were analysed. The pooled analysis of all trials showed that there was no significant difference in the incidence of clinical failure on about day 10 to 14 between the two groups (relative risk (RR), random-effects 1.09; 95% confidence interval (CI) 0.64 to 1.85). Sensitivity analysis showed a reduction of clinical failure in azithromycin-treated participants (RR 0.55; 95% CI 0.25 to 1.21) in three adequately concealed studies, compared to RR 1.32; 95% CI 0.70 to 2.49 in 12 studies with inadequate concealment. Twelve trials reported the incidence of microbial eradication and there was no significant difference between the two groups (RR 0.95; 95% CI 0.87 to 1.03). The reduction of adverse events in the azithromycin group was RR 0.76 (95% CI 0.57 to 1.00).. There is unclear evidence that azithromycin is superior to amoxicillin or amoxyclav in treating acute LRTI. In patients with acute bronchitis of a suspected bacterial cause, azithromycin tends to be more effective in terms of lower incidence of treatment failure and adverse events than amoxicillin or amoxyclav. Future trials of high methodological quality are needed.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Bronchitis; Drug Therapy, Combination; Humans; Pneumonia; Randomized Controlled Trials as Topic; Respiratory Tract Infections; Treatment Failure

The spectrum of acute lower respiratory tract infection ranges from acute bronchitis and acute exacerbations of chronic bronchitis to pneumonia. Annually approximately five million people die of acute respiratory tract infections. Among these, pneumonia represents the most frequent cause of mortality, hospitalization and medical consultation. Azithromycin is a new macrolide antibiotic, structurally modified from erythromycin and is noted for its activity against some gram-negative organisms associated with respiratory tract infections, particularly Haemophilus influenzae (H. influenzae).. To compare the effectiveness of azithromycin to amoxycillin or amoxycillin/clavulanic acid (amoxyclav) in the treatment of LRTI, in terms of clinical failure, incidence of adverse events and microbial eradication.. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2003), MEDLINE (January 1966 to January Week 3, 2004), and EMBASE (January 1988 to 2003).. Randomised and quasi-randomised controlled trials, which compared azithromycin to amoxycillin or amoxycillin/clavulanic acid in patients with clinical evidence of acute LRTI: acute bronchitis, pneumonia, and acute exacerbation of chronic bronchitis were studied.. The criteria for assessing study quality were generation of allocation sequence, concealment of treatment allocation, blinding, and completeness of the trial. All types of acute lower respiratory tract infections were initially pooled in the meta-analyses. Funnel plot was used to examine publication bias. The heterogeneity of results was investigated by the forest plot and Chi-square test. Index of I(2) was also used to measure inconsistency results among trials. Subgroup analysis was conducted for age, types of respiratory tract infection and types of antibiotic in control groups. Sensitivity analysis was conducted under the condition of trial size and concealment of treatment allocation.. Fourteen trials with 2,521 enrolled patients used 2,416 patients in the analysis. A total of 1,350 patients received azithromycin and 1,066 received amoxicillin or amoxicillin-clavulanic acid. The pooled analysis of all trials showed that there was no significant difference in the incidence of clinical failure on about day 10 to 14 after therapy started between the two groups (relative risk (RR) (random effects) 0.96; 95% CI 0.58 to 1.57). Sensitivity analysis showed that a reduction of clinical failure in azithromycin-treated patients (RR 0.52; 95% CI 0.24 to 1.12) in three adequately concealed studies, compared to RR 1.14 (95% CI 0.62 to 2.08) in eleven studies with inadequate concealment. Eleven trials reported the incidence of microbial eradication and there was no significant difference between the two groups (RR 0.98; 95% CI 0.91 to 1.07). The reduction of adverse events in azithromycin group was RR 0.75 (95% CI 0.56 to 1.00).. There is unclear evidence that azithromycin is superior to amoxicillin or amoxicillin-clavulanic acid in treating acute LRTI. Future trials with high methodological quality are needed.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Bronchitis; Drug Therapy, Combination; Humans; Pneumonia; Randomized Controlled Trials as Topic; Treatment Failure

Topics: Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bronchitis; Double-Blind Method; Drug Therapy, Combination; Haemophilus Infections; Haemophilus influenzae; Humans; Moraxella catarrhalis; Multicenter Studies as Topic; Neisseriaceae Infections; Pneumonia; Pneumonia, Pneumococcal; Randomized Controlled Trials as Topic; Respiratory Tract Infections; Staphylococcal Infections; Staphylococcus aureus; Streptococcus pneumoniae

Cefprozil was evaluated in four multicentre comparative studies in the treatment of acute respiratory tract infections. In two studies, cefprozil 500 mg q. 12 hours was compared to cefaclor 500 mg q. eight hours for ten days of therapy. Randomization was on a 2:1 (cefprozil:cefaclor) basis in the European centres and 1:1 in North America. The clinical efficacy in acute bronchitis was 88% (284 out of 324 patients) for cefprozil and 88% (183 out of 208) for cefaclor, with successful bacteriological eradication of the causative pathogen in 86% and 82% of the patients, respectively. Amongst the patients with acute exacerbations of chronic bronchitis, the clinical response rate of 80% (59 out of 74) for cefprozil appeared superior to that of cefaclor at 62% (p = 0.067), whilst the bacteriological response rates were 62% (36 out of 58) for cefprozil and 74% (20 out of 27) for cefaclor. In pneumonia, the clinical response rates for cefprozil and cefaclor therapy were similar, 82% vs. 79%, although bacteriological eradication rates were better for cefprozil at 82% than for cefaclor at 71%. In the comparison of cefprozil with cefuroxime axetil, a total of 170 patients were evaluable. The clinical and bacteriological response rates for cefprozil of 95% and 100% were better than those for cefuroxime axetil 500 mg q. 12 hours of 84% and 75%, respectively. In the cefprozil vs. amoxicillin-clavulanate, 500 mg q. eight hours comparative study, the two antibiotics displayed no significant difference in clinical or bacteriological responses.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adolescent; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Bronchitis; Cefaclor; Cefprozil; Cefuroxime; Cephalosporins; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Male; Multicenter Studies as Topic; Pneumonia; Prodrugs; Randomized Controlled Trials as Topic; Respiratory Tract Infections

A regimen of cefprozil (500 mg twice daily), a new oral cephalosporin with a broad in vitro spectrum of antimicrobial activity, was compared to standard regimens of cefaclor (500 mg three times daily), cefuroxime axetil (500 mg twice daily), or amoxicillin/clavulanate (500 mg/125 mg three times daily) for the treatment of lower respiratory tract infections (mainly bronchitis and acute exacerbations of chronic bronchitis) in adults in three open-label, randomized trials. In the first trial, in which bacterial pathogens were isolated in initial cultures for only one-third of the patients, 90% of the pathogens were susceptible to cefprozil. A satisfactory clinical response was noted for 84% of the evaluable patients who received cefprozil versus 79% of those who received cefaclor for treatment of lower respiratory tract infections; rates of bacteriologic efficacy were 82% and 78%, respectively. In the second study rates of satisfactory clinical response were 96% with cefprozil and 83% with cefuroxime axetil (P less than .03) for treatment of bronchitis; the respective bacteriologic response rates were 100% and 92%. In the third trial, clinical efficacy was 91% for cefprozil and 87% for amoxicillin/clavulanate for treatment of bronchitis; bacteriologic efficacy was 95% and 96%, respectively. Tolerability and safety profiles were comparable, except that there was a higher rate of diarrhea among patients who received amoxicillin/clavulanate (P = .03).

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Bronchopneumonia; Cefaclor; Cefprozil; Cefuroxime; Cephalosporins; Clavulanic Acids; Drug Therapy, Combination; Humans; Pneumonia, Pneumococcal

Two controlled clinical trials compared loracarbef (LY163892 with amoxicillin/clavulanate or amoxicillin in the treatment of acute exacerbations of chronic bronchitis. Collectively, of 1,057 patients enrolled, 390 qualified for analysis: group 1 comprised 200 patients treated with loracarbef (400 mg twice daily); group 2, 120 patients treated with amoxicillin/clavulanate (500 mg three times daily); and group 3, 70 patients treated with amoxicillin (500 mg three times daily). Symptomatic and bacteriologic outcomes were assessed at post-therapy (within 72 hours of therapy completion), and at late-posttherapy (10-14 days after therapy completion). These evaluations were combined to provide an "overall" evaluation that accounted for all unfavorable outcomes occurring at either the posttherapy or late-posttherapy visit. At the posttherapy evaluation, 93.0% of group 1 patients, 95.0% of group 2 patients, and 88.6% of group 3 patients demonstrated favorable clinical outcomes (cure or improvement). "Overall" favorable clinical outcomes were achieved in 88.0% of group 1 patients, 90.0% of group 2 patients, and 81.4% of group 3 patients. Bacteriologic results from the two studies could not be merged due to marked differences in how posttherapy bacteriologic results were assessed. The clinical significance of positive posttherapy sputum cultures was doubtful: 90% of patients with a positive sputum culture at the posttherapy visit who returned for the late-posttherapy visit had successful clinical outcomes documented at the late-posttherapy evaluation. Loracarbef was associated with a lower incidence of diarrhea and a higher incidence of headache as compared with amoxicillin/clavulanate. These results suggest that 400 mg loracarbef twice daily for 7 days is effective and safe in the treatment of acute exacerbations of chronic bronchitis.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Cephalosporins; Chronic Disease; Clavulanic Acids; Diarrhea; Drug Therapy, Combination; Europe; Female; Headache; Humans; Incidence; Male; Middle Aged; Treatment Outcome; United States

To evaluate the efficacy of oral anti-inflammatory or antibiotic treatment compared with placebo in the resolution of cough in patients with uncomplicated acute bronchitis and discoloured sputum.. Multicentre, parallel, single blinded placebo controlled, randomised clinical trial.. Nine primary care centres in Spain.. Adults aged 18 to 70 presenting symptoms associated with respiratory tract infection of less than one week's duration, with cough as the predominant symptom, the presence of discoloured sputum, and at least one other symptom of lower respiratory tract infection (dyspnoea, wheezing, chest discomfort, or chest pain).. Patients were randomised to receive either ibuprofen 600 mg three times daily, amoxicillin-clavulanic acid 500 mg/125 mg three times daily, or placebo three times daily for 10 days. The duration of symptoms was measured with a diary card.. Number of days with frequent cough after the randomisation visit.. 416 participants were randomised (136 to ibuprofen, 137 to antibiotic, and 143 to placebo) and 390 returned their symptom diaries fully completed. The median number of days with frequent cough was slightly lower among patients assigned to ibuprofen (9 days, 95% confidence interval 8 to 10 days) compared with those receiving amoxicillin-clavulanic acid (11 days, 10 to 12 days) or placebo (11 days, 8 to 14 days), albeit without statistically significant differences. Neither amoxicillin-clavulanic acid nor ibuprofen increased the probability of cough resolution (hazard ratio 1.03, 95% confidence interval 0.78 to 1.35 and 1.23, 0.93 to 1.61, respectively) compared with placebo. Adverse events were observed in 27 patients, and were more common in the antibiotic arm (12%) than ibuprofen or placebo arms (5% and 3%, respectively; P<0.01).. No significant differences were observed in the number of days with cough between patients with uncomplicated acute bronchitis and discoloured sputum treated with ibuprofen, amoxicillin-clavulanic acid, or placebo.. Current Controlled Trials ISRCTN07852892.

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Inflammatory Agents; Bronchitis; Cough; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Ibuprofen; Male; Middle Aged; Prospective Studies; Single-Blind Method; Spain; Sputum; Treatment Outcome

Despite guideline recommendations, there are no published randomised controlled trial data on the efficacy of antibiotics for chronic wet cough in children. The majority of children with chronic wet cough have protracted bacterial bronchitis (PBB), a recognised condition in multiple national guidelines. The authors conducted a parallel 1:1 placebo randomised controlled trial to test the hypothesis that a 2-week course of amoxycillin clavulanate is efficacious in the treatment of children with chronic wet cough.. 50 children (median age 1.9 years, IQR 0.9-5.1) with chronic (>3 weeks) wet cough were randomised to 2 weeks of twice daily oral amoxycillin clavulanate (22.5 mg/kg/dose) or placebo. The primary outcome was 'cough resolution' defined as a >75% reduction in the validated verbal category descriptive cough score within 14 days of treatment compared with baseline scores, or cessation of cough for >3 days. In selected children, flexible bronchoscopy and bronchoalveolar lavage (BAL) were undertaken at baseline.. Cough resolution rates (48%) were significantly higher in children who received amoxycillin clavulanate compared with those who received placebo (16%), p=0.016. The observed difference between proportions was 0.32 (95% CI 0.08 to 0.56). Post treatment, median verbal category descriptive score in the amoxycillin clavulanate group of 0.5 (IQR 0.0-2.0) was significantly lower than in the placebo group, 2.25 (IQR 1.15-2.9) (p=0.02). Pre-treatment BAL data were consistent with PBB in the majority of children, with no significant difference between groups.. A 2-week course of amoxycillin clavulanate will achieve cough resolution in a significant number of children with chronic wet cough. BAL data support the diagnosis of PBB in the majority of these children.. ACTRN 12605000533695.

Topics: Administration, Oral; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bronchitis; Bronchoalveolar Lavage Fluid; Child; Child, Preschool; Chronic Disease; Cough; Double-Blind Method; Drug Administration Schedule; Female; Humans; Infant; Male; Treatment Outcome

Perioperative antibiotic prophylaxis has significantly reduced wound infection rates in clean-contaminated head and neck surgical procedures but controversy still remains regarding the optimal antibiotic regime.. To examine the efficacy of different antibiotics in head and neck oncological surgery prophylaxis.. In this prospective, double-blind clinical trial, 189 patients with carcinoma of the upper aerodigestive tract were randomized to receive amoxicillin-clavulanate or cefazolin intravenously up to 1h before surgery and at 8-h intervals for an additional three doses.. An overall wound infection rate of 22% was observed. The infection rate in patients receiving cefazolin was 24% (22/92) vs. 21% (20/97) in those receiving amoxicillin-clavulanate; the difference was not statistically significant. Postoperative overall non-wound infection developed in 12% (22/189) patients; the rate of infection was 9.8% (9/92) in patients receiving cefazolin vs. 13.4% (13/97) in those receiving amoxicillin-clavulanate, without a statistically significant difference between the two groups. Gram-negative bacteria were more often isolated with Pseudomonas aeruginosa as the dominant species. The risk of postoperative infection was more influenced by the type of surgical procedure than by disease stage.. In clean-contaminated head and neck oncologic surgery amoxicillin-clavulanate prophylaxis was at least as efficient as cefazolin. However, when taking into account the fact that beta-lactamase containing strains have recently been spreading, amoxicillin-clavulanate should be the logical first choice.

Topics: Amoxicillin-Potassium Clavulanate Combination; Antibiotic Prophylaxis; Bronchitis; Carcinoma, Squamous Cell; Cefazolin; Double-Blind Method; Head and Neck Neoplasms; Humans; Injections, Intravenous; Laryngeal Neoplasms; Mouth Neoplasms; Pharyngeal Neoplasms; Pneumonia, Bacterial; Postoperative Complications; Prospective Studies; Pseudomonas aeruginosa; Pseudomonas Infections; Staphylococcal Infections; Streptococcal Infections; Surgical Wound Infection; Tracheitis

This post hoc analysis of data from a previous randomized, blinded, multicenter, parallel, noninferiority study assessed the bacterial etiology, symptom resolution, and tolerability of severe acute bacterial exacerbation of chronic bronchitis (ABECB) patients treated with either levofloxacin 750 mg QD for 5 days or amoxicillin/clavulanate 875 mg/125 mg BID for 10 days. Severe ABECB was defined as ABECB and forced expiratory volume in 1 second (FEV(1)) <50% of the predicted value, or (FEV(1)) of 50% to 65% of the predicted value plus comorbidities, or > or =4 exacerbations per year. A total of 369 patients were included in the intent-to-treat (ITT) population (187 treated with levofloxacin and 182 treated with amoxicillin/clavulanate), and 175 patients were microbiologically assessable (MA) (86 treated with levofloxacin and 89 treated with amoxicillin/clavulanate). In the ITT population, the mean age was 58.7 years, 49.1 % were male, and 48.2% were current smokers. At the on-treatment visit, a significantly higher proportion of MA patients in the levofloxacin group resolved purulent sputum production (57.5% vs 35.6%; P < 0.006), sputum production (65.4% vs 45.3%; P < 0.013), and cough (60.0% vs 44.0%; P < 0.045), compared with the amoxicillin/clavulanate group. However, no significant between-group differences were observed at posttreatment. A total of 341 pathogens were isolated, of which 143 (41.9%) were traditional ABECB flora, 181 (53.1%) were other gram-negative organisms, and 17 (5.0%) were gram-positive organisms. Overall susceptibility of the pathogens was 97.1% for levofloxacin and 90.6% for amoxicillin/clavulanate (P < 0.001). The prevalence of treatment-emergent adverse events was 42.1 % in patients who received levofloxacin and 48.6 % in those who received amoxicillin/clavulanate (95% CI,-4.0 to 17.0).

Topics: Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Bronchitis; Chronic Disease; Drug Administration Schedule; Female; Humans; Levofloxacin; Male; Ofloxacin

The efficacy of a new pharmacokinetically enhanced formulation of amoxycillin/clavulanate (AMX/CA) 2000/125 mg, twice daily, designed to provide adequate levels of amoxycillin over the 12-h dosing interval to eradicate penicillin-resistant Streptococcus pneumoniae (PRSP) with amoxycillin (+/-clavulanic acid) MICs of /=4 mg/l. In the pooled comparator group, the success rate at follow-up was 86.5% (45/52). For PRSP (AMX/CA MICs of 0.5-8 mg/l), the overall success rate was 98.2% (55/56) at follow-up for AMX/CA 2000/125 mg and 50.0% (2/4) for comparators. AMX/CA 2000/125 mg shows efficacy comparable to that of the comparators evaluated against S. pneumoniae infections. Due to its favorable pharmacokinetic/pharmacodynamic profile and promising clinical success, the new AMX/CA 2000/125 mg formulation should be considered for the empirical treatment of respiratory tract infections in regions with a high prevalence of antimicrobial-resistant S. pneumoniae and in patients at high risk of antimicrobial-resistant S. pneumoniae infection as this formulation covers many PRSP that are non-susceptible to amoxycillin (+/-clavulanic acid) (MICs of >/=4 mg/l) as well as common beta-lactamase-producing respiratory pathogens.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Double-Blind Method; Drug Administration Schedule; Drug Resistance, Bacterial; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Multicenter Studies as Topic; Pneumonia, Bacterial; Respiratory Tract Infections; Streptococcal Infections; Streptococcus pneumoniae; Treatment Outcome

Clarithromycin has established efficacy and safety in the treatment of respiratory infections.. This study examined the efficacy and safety of a new extended-release formulation of clarithromycin compared with amoxicillin/clavulanate in the treatment of acute exacerbation of chronic bronchitis (AECB).. This phase IIIB, multicenter, randomized, parallel-group, investigator-blinded study in patients with AECB and productive cough with purulent sputum compared treatment with extended-release clarithromycin (two 500-mg tablets once daily for 7 days) and amoxicillin/clavulanate (one 875-mg tablet twice daily for 10 days). Assessments were performed before treatment, between study days 10 and 12 (or within 48 hours after premature discontinuation), and between study days 17 and 21 (test of cure).. Of 287 patients randomized and treated, 270 were clinically evaluable (137 clarithromycin, 133 amoxicillin/clavulanate). Treatment groups were well matched in terms of demographic characteristics, medical condition, and history. Among clinically evaluable patients at test of cure, 85% and 87% of clarithromycin- and amoxicillin/clavulanate-treated patients, respectively, demonstrated clinical cure (as defined in 1998 draft US Food and Drug Administration guidelines); among clinically and bacteriologically evaluable patients, 92% versus 89%, respectively, demonstrated bacteriologic cure. Overall pathogen eradication rates were similar in the 2 groups (88% clarithromycin, 89% amoxicillin/clavulanate). Rates of premature discontinuation of study drug for any reason differed between treatments: 3% (4/142) of clarithromycin-treated patients versus 12% (17/145) of amoxicillin/clavulanate-treated patients (P = 0.005). One percent (2/142) and 6% (8/145) of the respective treatment groups discontinued study drug because of adverse events. Adverse events generally occurred with a similar frequency in the 2 groups; however, taste alteration was more common with clarithromycin (9/142 [6%]) than with amoxicillin/clavulanate (1/145 [1%]; P = 0.01). Mean severity scores for gastrointestinal adverse events showed a significant difference between groups (1.16 for clarithromycin-treated patients and 1.58 for amoxicillin/clavulanate-treated patients: P = 0.016).. The results of this study demonstrate the clinical and bacteriologic equivalence and improved gastrointestinal tolerability of a 7-day course of once-daily extended-release clarithromycin relative to a 10-day course of twice-daily amoxicillin/clavulanate in the treatment of AECB.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Clarithromycin; Female; Humans; Male; Middle Aged; Tablets

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

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bronchitis; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Treatment Outcome

In this study the efficacy and cost-effectiveness of i.v. ceftriaxone 1 g once daily (CTX) was compared with standard i.v. antibiotic treatment (STD) for lower respiratory tract infections (LRTI). STD was given according to the guidelines of the American Thoracic Society and consisted of either cefuroxime 1500 mg three times daily (q8h), amoxicillin/clavulanic acid 1200 mg q8h or ceftriaxone 2 g once daily; each with or without a macrolide. After a minimum of 5 days i.v. therapy, patients could be switched to oral therapy. One hundred patients were enrolled in the study; 52 patients received CTX and 48 STD. Groups were comparable with respect to demographic and baseline characteristics. Seventy patients had a confirmed diagnosis of pneumonia. Twenty-nine patients had a severe type I exacerbation of chronic bronchitis. In one patient the diagnosis of LRTI could not be confirmed. In approximately 50% of the patients a microbiological diagnosis could be made. The most important isolated pathogens from sputum and blood were (positive blood cultures in brackets): Streptococcus pneumoniae 14 (9) and Haemophilus influenzae 16. Mean duration of i.v. therapy was 7.4 days in both groups. Average duration of hospitalisation was 15.0 days for CTX patients and 15.9 days for STD patients. Overall cure and improvement rate at the end of treatment was 47 (90%) for patients receiving ceftriaxone 1 g compared to 37 (77%) for patients receiving standard therapy. Pathogens were eradicated or presumed to be eradicated in 84% of the CTX patients and in 76% of the STD patients. Mean total costs per treatment were lower for CTX than for STD treatment: NLG 169 versus 458. These results show, that i.v. ceftriaxone 1 g once daily is as effective as standard therapy in the treatment of LRTI and that its use reduces treatment costs, in view of the multiple daily dosing regimens of most standard therapies.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bronchitis; Ceftriaxone; Cephalosporins; Chronic Disease; Drug Administration Schedule; Drug Costs; Female; Follow-Up Studies; Humans; Male; Middle Aged; Pneumonia

A multinational, multicentre, randomized, prospective, parallel-group study compared treatment with ciprofloxacin administered as an oral suspension (500 mg twice daily for 7 days) with co-amoxiclav tablets (625 mg three times daily for 7 days) in patients suffering from acute exacerbations of chronic bronchitis (AECB). A total of 147 of 165 cases treated with ciprofloxacin (89.1%) and 146 of 162 cases treated with co-amoxiclav (90.1%) were classified as being clinical successes at the primary efficacy assessment 7 days after the end of therapy (assessed as reduced cough, improvement in dyspnoea, reduction in 24-h sputum volume or reduced purulence of sputum). Treatment equivalence was statistically confirmed; treatment difference:--1.0%, 95% CI--6.6% and 4.5%. Before treatment, 128 bacterial strains were isolated from 103 patients (60 ciprofloxacin and 68 co-amoxiclav). The most commonly isolated organism was Haemophilus influenzae (60 isolates), followed by Moraxella catarrhalis (12 isolates), Streptococcus pneumoniae (11 isolates) and Staphylococcus aureus (10 isolates). At day 14, 40 of 46 ciprofloxacin-treated patients (87.0%) and 46 of 55 co-amoxiclav-treated patients (83.6%) who were valid for bacteriological analysis were classified as being bacteriological success (classed as eradication, eradication with colonization or presumed eradication; treatment difference: 3.3%, 95% CI--8.3% and 14.9%). The adverse event profile was comparable between treatment groups. Most adverse events considered possibly or probably related to study drug were related to the gastrointestinal system and were of mild or moderate severity: nausea (13% ciprofloxacin, 10.6% co-amoxiclav), flatulence (10.3% ciprofloxacin, 3.9% co-amoxiclav), abdominal pain (7.6% ciprofloxacin, 7.3% co-amoxiclav) and diarrhoea (4.3% ciprofloxacin, 6.7% co-amoxiclav). We concluded that a 7-day course of ciprofloxacin suspension is equivalent to a 7-day course of co-amoxiclav tablets in terms of clinical and bacteriological efficacy and tolerability for the treatment of AECB. Thus, ciprofloxacin suspension may offer a suitable alternative treatment for AECB patients who have difficulty in swallowing, or who prefer liquid medications to tablets.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Bronchitis; Ciprofloxacin; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Prospective Studies; Tablets; Treatment Outcome

Although there have been a number of studies in adults, to date there has been little research into sequential antimicrobial therapy (SAT) in paediatric populations. The present study evaluates the impact of a SAT protocol for the treatment of severe lower respiratory tract infection in paediatric patients. The study involved 89 paediatric patients (44 control and 45 SAT). The SAT patients had a shorter length of hospital stay (4.0 versus 8.3 days), shorter duration of inpatient antimicrobial therapy (4.0 versus 7.9 days) with the period of iv therapy being reduced from a mean of 5.6 to 1.7 days. The total healthcare costs were reduced by 52%. The resolution of severe lower respiratory tract infection with a short course of iv antimicrobials, followed by conversion to oral therapy yielded clinical outcomes comparable to those achieved using longer term iv therapy. SAT proved to be an important cost-minimizing tool for realizing substantial healthcare costs savings.

Topics: Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bronchitis; Cefixime; Cefotaxime; Child; Child, Preschool; Clinical Protocols; Drug Administration Schedule; Female; Health Care Costs; Humans; Infant; Injections, Intravenous; Length of Stay; Male; Pneumonia; Treatment Outcome

Cefaclor and amoxycillin/clavulanate are active against Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis and Staphylococcus aureus--pathogens commonly associated with acute exacerbations of chronic bronchitis (AECB). This randomised, parallel-group, single-blind, multicentre study investigated the comparative efficacy and safety of 7-day treatment regimens of cefaclor AF (750 mg b.d. [n = 73]) and amoxycillin/clavulanate (875/125 mg b.d. [n = 72]) in AECB. A favourable clinical response was obtained in 95.9% of patients on cefaclor AF and 97.2% of patients on amoxycillin/clavulanate. There were no statistically significant differences between the groups for improvement in clinical response measured by pulmonary peak expiratory flow (PPEF), or for common symptoms associated with AECB. Both agents were well tolerated, with no statistically significant differences in overall safety; however, nausea and vomiting, and abdominal pain, the most frequently occurring adverse events in the amoxycillin/clavulanate group, were not reported in the cefaclor group. In conclusion, cefaclor AF and amoxycillin/clavulanate have similar efficacy and safety profiles in the treatment of AECB.

Topics: Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Bronchitis; Cefaclor; Cephalosporins; Chronic Disease; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Single-Blind Method

Treatments with once-daily trovafloxacin (200 or 100 mg) and amoxicillin/clavulanic acid (500/125 mg three times daily) were compared in adults with acute exacerbations of chronic obstructive bronchitis. At end of treatment, 95% (113/119) of clinically evaluable patients receiving trovafloxacin 200 mg, 98% (113/115) of patients treated with trovafloxacin 100 mg and 97% (113/117) of patients receiving amoxicillin/clavulanic acid were cured or improved. At study end, 91%, 87% and 88%, respectively, were cured or improved. At end of treatment, trovafloxacin 200 mg eradicated Haemophilus influenzae in 97% of patients, Streptococcus pneumoniae in 90% and Chlamydia pneumoniae in 100%. The respective eradication rates for trovafloxacin 100 mg were 84%, 100% and 100%; those for amoxicillin/clavulanic acid were 92%, 100% and 100%. At study end, trovafloxacin 200 mg totally eradicated all three pathogens. Trovafloxacin 100 mg eradicated Haemophilus influenzae in 91% of patients, Streptococcus pneumoniae in 100% and Chlamydia pneumoniae in 80%. Respective eradication rates for amoxicillin/clavulanic acid were 78%, 100% and 80%. Only 7% (10/144) of patients receiving trovafloxacin 200 mg reported treatment-related adverse events, as did 7% (10/135) of patients given trovafloxacin 100 mg and 12% (17/140) of patients given amoxicillin/clavulanic acid.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Bronchitis; Chlamydia Infections; Chronic Disease; Drug Therapy, Combination; Female; Fluoroquinolones; Haemophilus Infections; Humans; Male; Middle Aged; Naphthyridines; Pneumococcal Infections

Step-by-step therapy of patients with pneumonia and exacerbated chronic bronchitis with amoxyclav (amoxycillin/potassium clavulanate) in a dose of 1.2 g administered intravenously dropwise every 8 hours for the first 2 days of the treatment with subsequent oral use of the drug in a dose of 625 mg thrice a day for 5 days proved to be highly efficient. The recovery and improvement were stated in 19 (95 per cent) out of 20 patients. The adverse reaction (urticaria) was observed in 1 patient. Identical results were recorded in a comparative randomized trial with the use of cefotaxime in a dose of 1.0 g intramuscularly every 8 hours for 7 days. The pharmacoeconomic estimate showed the expediency of the step-by-step therapy with the use of amoxycillin/potassium clavulanate.

Topics: Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Cefotaxime; Cephalosporins; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Humans; Injections, Intravenous; Length of Stay; Male; Middle Aged; Pneumonia, Bacterial; Treatment Outcome

Amoxyclav (amoxycillin/potassium clavulanate, A/PC) was used in the treatment of 55 children with acute bronchitis and pneumonia. The drug was administered in a dose of 20-40 mg/kg body weight a day in 3 portions. The treatment course was 4 to 10 days. The treatment was performed under careful clinicoroent-genologic control. The clinical picture of the disease in the children was characterized by a moderate process which made it possible to treat the children as outpatients. The clinical efficacy amounted to 90.5 per cent. The isolates of Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus aureus and Haemophilus influenzae proved to be susceptible to A/PC. It may be used as the 1st class agent in the treatment of children with lower respiratory tract infection.

Topics: Administration, Oral; Adolescent; Ambulatory Care; Amoxicillin-Potassium Clavulanate Combination; beta-Lactam Resistance; Bronchitis; Child; Child, Preschool; Community-Acquired Infections; Drug Therapy, Combination; Female; Haemophilus influenzae; Humans; Infant; Male; Pneumonia, Bacterial; Staphylococcus aureus; Streptococcus pneumoniae

The efficacy and safety of a 3-day regimen of azithromycin prescribed in the new tablet form and of a 10-day regimen of amoxycillin clavulanic acid (co-amoxiclav, Augmentin) were compared in patients with acute lower respiratory tract infections. Of the 144 enrolled patients, 123 had a Type 1 acute exacerbation of chronic bronchitis (AECB), three patients had pneumonia, and 18 had purulent bronchitis. Treatment was successful, defined as cure or major improvement on day 14, in 59/62 (95%) patients in the azithromycin treatment group compared with 54/61 (90%) patients in the co-amoxiclav. At 30 days, the incidence of success was 77% (48/62) in the azithromycin treated group, compared with 66% (40/61) of co-amoxiclav-treated patients. At 60 days, incidences were 66% (41/62) and 59% (36/61), respectively. Several pathogens were isolated: Haemophilus influenzae in 21 patients (minimum inhibitory concentration (MIC) range for azithromycin 0.12-4 mg/l; co-amoxiclav 0.25-4 mg/l); Streptococcus pneumoniae in nine (MIC azithromycin < or = 0.06 > or = 256 mg/l; co-amoxiclav < or = 0.06-1 mg/l); and Moraxella catarrhalis in 11 (MIC azithromycin < or =0.06-2 mg/l; co-amoxiclav < or = 0.06-0.5 mg/l). Microbiological response rates were comparable. A significant correlation between clinical and microbiological cure was found (p = 0.02, power 0.6). In 15 (10%) patients, positive serology for viruses or atypical pathogens was found. In the co-amoxiclav-treatment group, 24 patients had mild adverse events (12 diarrhoea), compared with 27 treated with azithromycin (p = 0.47). It is concluded that a 3-day regimen of azithromycin prescribed as tablets is as clinically and microbiologically effective as a 10-day regimen of co-amoxiclav in the treatment of acute lower respiratory tract infections. Moreover, since the percentage of viral infections was low and a significant correlation between microbiological and clinical cure was found, this study shows that clinical symptoms can be used to establish which patients with AECB (Type 1) should be treated with antimicrobial agents.

Topics: Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Bronchitis; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Pneumonia, Bacterial; Treatment Outcome

An open randomized trial was conducted in 142 hospitalized and out-patients with acute purulent exacerbation of chronic bronchitis to compare the clinical efficacy and tolerability of azithromycin (n = 69) and amoxicillin/clavulanic acid (n = 73). Azithromycin (500 mg) was administered as a single dose for three days and amoxicillin/clavulanic acid (amoxicillin 875 mg-clavulanic acid 125 mg) was given b.i.d. for 8 days (8.16 +/- 1.18). Before therapy and 24-48 hours after the end of treatment, sputum culture (by positioning five orthodontal swabs at the opening of salivary gland ducts after a washing of the oral cavity with sterile saline solution to avoid oral contamination), chest X-rays, arterial blood gas analysis, trials of respiratory functions and routine blood tests were performed. In the azithromycin group (69 patients) the efficacy rate was 67.6% (46 patients: 34 cured and 12 improved); in 22 patients (32.4%) the treatment failed; 1 patient was not evaluated because of no follow-up. The overall efficacy rate in the amoxicillin/clavulanic acid group (73 patients) was 97.3% (71 patients: 60 cured and 11 improved); in 1 patient (1.4%) the treatment failed and 1 patient was a drop-out for side effects. All pathogens isolated before treatment were susceptible to the antibiotics administered. At the end of treatment microbiological efficacy was 67.1% in the azithromycin group and 98.6% in the amoxicillin/clavulanic acid group. The tolerability was judged good in both treatment groups. Side effects were observed in 1 patient treated with amoxicillin/clavulanic acid (diarrhea), which imposed interruption of treatment, and in 2 patients from the azithromycin group (gastralgia and biochemical laboratory tests: renal function).(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Azithromycin; Bacterial Infections; Bronchitis; Chronic Disease; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Sputum

Acute lower respiratory tract infections in children are a worldwide public health problem, with an estimated 4 million potentially preventable deaths every year. Until recently, penicillin and related drugs were the treatment of choice for empiric therapy of paediatric lower respiratory tract infections. However, concerns over the emergence of penicillin-resistant strains of Streptococcus pneumoniae and beta-lactamase-producing strains of Haemophilus influenzae and Moraxella catarrhalis have led physicians to turn increasingly towards alternatives, such as the third generation cephalosporins. The oral extended spectrum cephalosporin cefpodoxime proxetil is highly active against the bacterial pathogens commonly associated with childhood lower respiratory tract infections. In order to evaluate its clinical efficacy in children with acute febrile lower respiratory tract infections, an international, multicenter, comparative, randomized open study was conducted in children ages 3 months to 11.5 years. Of 348 cases enrolled, 234 were randomized to cefpodoxime proxetil (8 mg/kg/day twice daily) and 114 to amoxicilin/clavanulate (amoxicillin 40 mg/kg/day 3 times a day). The duration of treatment was 10 days. Pretreatment diagnosis was pneumonia in 292 patients, bronchiolitis in 19 patients and acute bronchitis in 37 patients. Pathogens isolated from 59 cases included H. influenzae (47.5%), S. pneumoniae (23.7%), M. catarrhalis (11.9%) and Haemophilus parainfluenzae (6.8%). Clinical efficacy was evaluable in 278 children at the end of treatment when 95.2% of patients in the cefpodoxime proxetil group and 96.7% of patients in the amoxicillin/clavanulate group showed a satisfactory clinical response (cured or improved). The improvement was sustained at the follow-up visit, 10 to 20 days after completion of treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchiolitis; Bronchitis; Cefpodoxime Proxetil; Ceftizoxime; Child; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Humans; Infant; Pneumonia, Bacterial; Treatment Outcome

Five hundred thirty-seven patients were enrolled in two independent, investigator-blinded, multicenter, randomized clinical trials comparing the clinical and bacteriologic efficacies and the safety of 5- or 10-day treatment with cefuroxime axetil with those of 10-day treatment with amoxicillin-clavulanate in the treatment of secondary bacterial infections of acute bronchitis. Patients received either 5 or 10 days of treatment (n = 177 in each group) with cefuroxime axetil at 250 mg twice daily or 10 days of treatment (n = 183) with amoxicillin-clavulanate at 500 mg three times daily. Patients in the cefuroxime axetil (5 days) group received placebo on days 6 to 10. Bacteriologic assessments were based on sputum specimen cultures obtained preceding and, when possible, following treatment. Organisms were isolated from the pretreatment sputum specimens of 242 of 537 (45%) patients, with the primary pathogens being Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, and Staphylococcus aureus (28, 25, 13, 9, and 8% of isolates, respectively). Pathogens were eradicated or presumed to be eradicated in 87% (52 of 60), 91% (53 of 58), and 86% (60 of 70) of bacteriologically evaluable patients treated with cefuroxime axetil (5 days), cefuroxime axetil (10 days), and amoxicillin-clavulanate, respectively. A satisfactory clinical outcome (cure or improvement) was achieved in 82% (107 of 130), 86% (117 of 136), and 83% (130 of 157) of the clinically evaluable patients treated with cefuroxime axetil (5 days), cefuroxime axetil (10 days), and amoxicillin-clavulanate, respectively. Treatment with amoxicillin-clavulanate was associated with a significantly higher incidence of drug-related adverse events than was treatment with cefuroxime axetil for either 5 or 10 days (P = 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal adverse events (37 versus 19 and 15%, respectively; P < 0.001), particularly diarrhea and nausea. These results indicate that treatment with cefuroxime axetil at 250 mg twice daily for 5 days is as effective as treatment for 10 days with either the same dose of cefuroxime axetil or amoxicillin-clavulanate at 500 mg three times daily in patients with acute bronchitis. In addition, treatment with cefuroxime axetil for either 5 or 10 days is associated with significantly fewer gastrointestinal adverse events, particularly diarrhea and nausea, than is 10-day treatment with amoxic

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Bronchitis; Cefuroxime; Cephalosporins; Child; Clavulanic Acids; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Prospective Studies; Treatment Outcome

In an open randomized study 218 outpatients (159 males and 59 females) ranging between 18 and 85 years of age (mean 61.9) suffering from bacterial exacerbation of chronic bronchitis have been randomly treated: 79 with co-amoxiclav (amoxicillin 875 mg+clavulanic acid 125 mg) twice daily, 69 with cefixime (400 mg) once daily, and 70 with ciprofloxacin (500 mg) twice daily for an average period of 10 days. Before treatment start, 234 bacterial strains (105 Gram-positive and 129 Gram-negative) were isolated as the cause of exacerbation; the leading pathogens were Streptococcus pneumoniae and Haemophilus spp. Eradication rates at the end of treatment were 82.2% for the co-amoxiclav group, 77.6% for the cefixime group, and 81.2% for ciprofloxacin group. Clinical success (cure+improvement) was obtained in 90.8% of the cases treated with co-amoxiclav, in 80.9% for the cefixime group and in 85.7% of patients treated with ciprofloxacin. Seven adverse events (8.9%) of which 4 cases of diarrhea and 3 of itching, were recorded in the co-amoxiclav group. Eleven adverse events (14.7%) were recorded in the cefixime group including gastrointestinal disturbances in 6 patients and mild to moderate increase of liver function in 2. Nine adverse events (12.9%) occurred in the ciprofloxacin group, including insomnia in 3 patients, gastrointestinal disturbances in 2, and serious increase of liver function tests in one patient. It can be concluded that there were no statistically significant differences among the three treatment groups. However, co-amoxiclav demonstrated a higher efficacy rate than cefixime and ciprofloxacin and was better tolerated. Therefore, it can be used as a first-choice drug in the treatment of exacerbation of chronic bronchitis.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bronchitis; Cefixime; Cefotaxime; Chronic Disease; Ciprofloxacin; Clavulanic Acids; Drug Therapy, Combination; Evaluation Studies as Topic; Female; Gram-Negative Bacteria; Gram-Positive Bacteria; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Treatment Outcome

In this open comparative and prospective study 180 adults of either sex were randomised to treatment with either amoxicillin/clavulanic acid (AMC) 500/125mg tid or cefetamet pivoxil (CAT) 500mg bid for 7 days. Demographic data and assessable findings were similar in both groups. Clinical outcomes of 169 assessable patients showed high efficacy of both drugs: 92% with AMC and 96% with CAT. Bacteriological response rates were equivalent in 141 evaluable cases: 84% vs. 89%, respectively. Baseline susceptibility testing (DIN) revealed a notable number of Haemophilus species either intermediately susceptible or resistant to AMC. Gastrointestinal disorders predominated among the adverse events with diarrhea occurring nearly twice as often in the AMC group. CAT is an effective and safe alternative option in the treatment of AECB in adults. The advantage of CAT is its enhanced activity against gram-negative bacteria. It is well tolerated.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Ceftizoxime; Cephalosporins; Chronic Disease; Clavulanic Acids; Drug Therapy, Combination; Female; Gastrointestinal Diseases; Haemophilus Infections; Haemophilus influenzae; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Prospective Studies

Cefprozil was evaluated in four multicentre comparative studies in the treatment of acute respiratory tract infections. In two studies, cefprozil 500 mg q. 12 hours was compared to cefaclor 500 mg q. eight hours for ten days of therapy. Randomization was on a 2:1 (cefprozil:cefaclor) basis in the European centres and 1:1 in North America. The clinical efficacy in acute bronchitis was 88% (284 out of 324 patients) for cefprozil and 88% (183 out of 208) for cefaclor, with successful bacteriological eradication of the causative pathogen in 86% and 82% of the patients, respectively. Amongst the patients with acute exacerbations of chronic bronchitis, the clinical response rate of 80% (59 out of 74) for cefprozil appeared superior to that of cefaclor at 62% (p = 0.067), whilst the bacteriological response rates were 62% (36 out of 58) for cefprozil and 74% (20 out of 27) for cefaclor. In pneumonia, the clinical response rates for cefprozil and cefaclor therapy were similar, 82% vs. 79%, although bacteriological eradication rates were better for cefprozil at 82% than for cefaclor at 71%. In the comparison of cefprozil with cefuroxime axetil, a total of 170 patients were evaluable. The clinical and bacteriological response rates for cefprozil of 95% and 100% were better than those for cefuroxime axetil 500 mg q. 12 hours of 84% and 75%, respectively. In the cefprozil vs. amoxicillin-clavulanate, 500 mg q. eight hours comparative study, the two antibiotics displayed no significant difference in clinical or bacteriological responses.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adolescent; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Bronchitis; Cefaclor; Cefprozil; Cefuroxime; Cephalosporins; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Male; Multicenter Studies as Topic; Pneumonia; Prodrugs; Randomized Controlled Trials as Topic; Respiratory Tract Infections

The efficacy and safety of a three-day regimen of azithromycin (500 mg od) and a ten-day regimen of co-amoxiclav (625 mg tid) were compared in a single-blind study in 99 patients with acute lower respiratory tract infections. Of these, 70 (71%) suffered an infective exacerbation of their chronic obstructive pulmonary disease. Nine patients had pneumonia and 19 purulent bronchitis. Treatment success, defined as cure or improvement, occurred in 43 of 48 (90%) patients in the azithromycin group, compared with 45 of 51 (88%) patients in the co-amoxiclav group. The most common isolated pathogens were Haemophilus influenzae (25 cases; MIC range of azithromycin (A) < or = 0.06-4 mg/L; for co-amoxiclav (CA) 0.25-4 mg/L; Streptococcus pneumoniae (10 cases; A: < or = 0.06- > 128; CA: < or = 0.06); and Moraxella catarrhalis (four cases; A: < or = 0.06; CA: < or = 0.06-0.25). Microbiological response rates were comparable in the two groups. In 5% of patients, serological evidence for virus or atypical pathogens was found. Thirteen (26%) patients treated with co-amoxiclav had gastrointestinal complaints (seven with diarrhoea), compared with five (10%) treated with azithromycin (P = 0.09). Additional complaints occurred in three patients treated with co-amoxiclav and in one patient treated with azithromycin. It was concluded that a three-day regimen of azithromycin was as effective, clinically and microbiologically, as a ten-day regimen of co-amoxiclav in the treatment of acute lower respiratory tract infections.

Topics: Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Azithromycin; Bronchitis; Clavulanic Acids; Drug Administration Schedule; Drug Combinations; Erythromycin; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Male; Middle Aged; Moraxella catarrhalis; Neisseriaceae Infections; Pneumococcal Infections; Respiratory Tract Infections; Single-Blind Method; Streptococcus pneumoniae

In a large multinational study, the clinical and bacteriological efficacy of intravenous cefuroxime 750 mg t.i.d. followed by oral cefuroxime axetil 500 mg b.i.d. was compared to that of amoxicillin plus clavulanic acid (CA) administered as 1.2 g intravenously t.i.d. followed by 625 mg orally t.i.d. in the treatment of lower respiratory tract infections in hospitalised patients. A total of 512 patients were entered (256 in each treatment group). All were suffering from pneumonia or acute exacerbations of chronic bronchitis or bronchiectasis and required initial parenteral antibiotic therapy. Parenteral therapy lasted 48 to 72 h and was followed by five days of oral therapy. The clinical responses in the two treatment groups were very similar: 223 of 256 (87.1%) patients were cured or improved with cefuroxime/cefuroxime axetil compared to 220 of 256 (85.9%) with amoxicillin/CA. Positive pre-treatment sputum samples were obtained from 44% of the patients. Clearance rates obtained were again similar: 72.8% with cefuroxime/cefuroxime axetil and 70% with amoxicillin/CA. Ten percent of the isolates were beta-lactamase producers, similar numbers of which were cleared in both groups. Both regimens were generally well tolerated, with only 5% of patients treated with the cefuroxime regimen and 4.3% of patients treated with amoxicillin/CA experiencing drug-related adverse events. Cefuroxime/cefuroxime axetil "follow-on" therapy produces clinical and bacteriological efficacy equivalent to that of amoxicillin/CA, with the advantage of twice daily oral administration.

Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchiectasis; Bronchitis; Cefuroxime; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Injections, Intravenous; Male; Middle Aged; Pneumonia; Prodrugs; Respiratory Tract Infections

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

A regimen of cefprozil (500 mg twice daily), a new oral cephalosporin with a broad in vitro spectrum of antimicrobial activity, was compared to standard regimens of cefaclor (500 mg three times daily), cefuroxime axetil (500 mg twice daily), or amoxicillin/clavulanate (500 mg/125 mg three times daily) for the treatment of lower respiratory tract infections (mainly bronchitis and acute exacerbations of chronic bronchitis) in adults in three open-label, randomized trials. In the first trial, in which bacterial pathogens were isolated in initial cultures for only one-third of the patients, 90% of the pathogens were susceptible to cefprozil. A satisfactory clinical response was noted for 84% of the evaluable patients who received cefprozil versus 79% of those who received cefaclor for treatment of lower respiratory tract infections; rates of bacteriologic efficacy were 82% and 78%, respectively. In the second study rates of satisfactory clinical response were 96% with cefprozil and 83% with cefuroxime axetil (P less than .03) for treatment of bronchitis; the respective bacteriologic response rates were 100% and 92%. In the third trial, clinical efficacy was 91% for cefprozil and 87% for amoxicillin/clavulanate for treatment of bronchitis; bacteriologic efficacy was 95% and 96%, respectively. Tolerability and safety profiles were comparable, except that there was a higher rate of diarrhea among patients who received amoxicillin/clavulanate (P = .03).

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Bronchopneumonia; Cefaclor; Cefprozil; Cefuroxime; Cephalosporins; Clavulanic Acids; Drug Therapy, Combination; Humans; Pneumonia, Pneumococcal

Two controlled clinical trials compared loracarbef (LY163892 with amoxicillin/clavulanate or amoxicillin in the treatment of acute exacerbations of chronic bronchitis. Collectively, of 1,057 patients enrolled, 390 qualified for analysis: group 1 comprised 200 patients treated with loracarbef (400 mg twice daily); group 2, 120 patients treated with amoxicillin/clavulanate (500 mg three times daily); and group 3, 70 patients treated with amoxicillin (500 mg three times daily). Symptomatic and bacteriologic outcomes were assessed at post-therapy (within 72 hours of therapy completion), and at late-posttherapy (10-14 days after therapy completion). These evaluations were combined to provide an "overall" evaluation that accounted for all unfavorable outcomes occurring at either the posttherapy or late-posttherapy visit. At the posttherapy evaluation, 93.0% of group 1 patients, 95.0% of group 2 patients, and 88.6% of group 3 patients demonstrated favorable clinical outcomes (cure or improvement). "Overall" favorable clinical outcomes were achieved in 88.0% of group 1 patients, 90.0% of group 2 patients, and 81.4% of group 3 patients. Bacteriologic results from the two studies could not be merged due to marked differences in how posttherapy bacteriologic results were assessed. The clinical significance of positive posttherapy sputum cultures was doubtful: 90% of patients with a positive sputum culture at the posttherapy visit who returned for the late-posttherapy visit had successful clinical outcomes documented at the late-posttherapy evaluation. Loracarbef was associated with a lower incidence of diarrhea and a higher incidence of headache as compared with amoxicillin/clavulanate. These results suggest that 400 mg loracarbef twice daily for 7 days is effective and safe in the treatment of acute exacerbations of chronic bronchitis.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Cephalosporins; Chronic Disease; Clavulanic Acids; Diarrhea; Drug Therapy, Combination; Europe; Female; Headache; Humans; Incidence; Male; Middle Aged; Treatment Outcome; United States

Forty-eight patients with acute bronchitis and four with pneumonia were randomly assigned to receive five doses (500 mg on day 1, plus 250 mg/day on days 2-5) of azithromycin; 54 patients with acute bronchitis and four with pneumonia were assigned 30 doses (625 mg every eight hours for ten days) of amoxicillin/clavulanic acid (CA). The two regimens were equally effective, with clinical improvement or cure in 92% and 87% of patients respectively, bacteriological cure in 89% and 86%, with 91% and 89% of pathogens eliminated. Minor side effects occurred in 6% and 12% of patients in the two groups, respectively. No major abnormalities in laboratory safety parameters were seen in either group.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Azithromycin; Bronchitis; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Erythromycin; Female; Humans; Male; Middle Aged; Pneumonia; Pseudomonas aeruginosa; Streptococcus pneumoniae

Augmentin (875 amoxicillin and 125 mg potassium clavulanate) was administered orally to patients with chronic bronchitis. Concentrations of amoxicillin and clavulanic acid were measured in serum, sputum and urine. Peak serum levels for amoxicillin of 11.23 +/- 2.61 micrograms/ml were observed at 2 hours and for clavulanic acid of 2.55 +/- 0.54 micrograms/ml at 1 hour. After 9 hours, 50% of the amoxicillin and 39% of the clavulanic acid had been renally excreted. The peak sputum concentration of amoxicillin was 1.31 +/- 0.42 micrograms/ml at 4 hours and of clavulanate was 0.79 +/- 0.23 micrograms/ml at 2 hours. Patients awaiting surgery received an oral dose of augmentin as above. Samples of lung, tonsil, middle ear mucosa and prostate were obtained and tissue concentrations of both compounds measured. Peak levels of amoxicillin ranged from 0.87 micrograms/g (tonsil) to 2.56 micrograms/g (lung) and of clavulanic acid from 0.20 micrograms/g (prostate) to 0.56 micrograms/g (lung) between 3 and 4 hours after dosing.

Topics: Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Chronic Disease; Clavulanic Acids; Drug Therapy, Combination; Humans; Multicenter Studies as Topic; Tissue Distribution

The efficacy and safety of ofloxacin 400 mg once daily and amoxycillin/clavulanic acid 500/125 mg three times daily were compared in a double-blind manner in patients with an acute exacerbation of chronic bronchitis. Of 102 patients enrolled, 95 (93%) could be assessed for effectiveness. Treatment success was achieved in 41 (84%) of 49 patients in the ofloxacin group compared with 41 (89%) of 46 patients in the amoxycillin/clavulanic acid group. One patient who received ofloxacin and four patients in the amoxycillin/clavulanic acid group stopped medication because of unacceptable side effects. Microbiological results were evaluable in 47% of the patients. Predominant initial pathogens were Haemophilus influenzae, Streptococcus pneumoniae, sometimes in combination, and less frequently Branhamella catarrhalis. In two patients with clinical failure, randomized to ofloxacin, the initial pneumococcal strains persisted in the sputum after treatment.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Chronic Disease; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Humans; Ofloxacin; Remission Induction

This European, multicentre trial evaluated the efficacy and tolerance of cefpodoxime proxetil in comparison with co-amoxiclav (amoxycillin plus clavulanic acid) in the treatment of acute exacerbations of chronic bronchitis. The study design was double-blind and double-placebo controlled. Doses of either 200 mg bd of cefpodoxime proxetil or 500 mg/125 mg tds amoxycillin plus clavulanic acid were given orally for 9.6 +/- 1.8 days. Two hundred and fifty-one patients were enrolled in 27 centres in West Germany, France, and Italy. The overall clinical efficacy was 97.2% in the cefpodoxime proxetil group compared with 94.7% in the co-amoxiclav group. Fifty-eight adverse events, mainly gastrointestinal, occurred in 42 patients with no significant difference between the groups. A significant difference in the number of resistant pathogens on pre-treatment culture to the advantage of cefpodoxime was noted. In our experience, both drugs were of similar value in the treatment of respiratory tract infections. Thus, cefpodoxime proxetil should be an effective antibiotic for the treatment of acute exacerbations of chronic bronchitis.

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Cefpodoxime Proxetil; Ceftizoxime; Chronic Disease; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Prodrugs

This investigation compared the efficacy of oral formulations of amoxycillin/clavulanate and ciprofloxacin in acute exacerbations of chronic bronchitis. Forty patients were randomized to receive either Augmentin (1,000 mg amoxycillin +250 mg clavulanate) tds or ciprofloxacin (500 mg) bd. During and before therapy sputum samples were taken for bacteriology, sputum volume measurement and histamine determination. Lung function was also monitored. From sputum, 143 bacterial isolates and 15 yeast strains were obtained before therapy. During therapy with amoxycillin/clavulanate the incidence of Gram-positive isolates decreased significantly whereas ciprofloxacin left their frequency unchanged. On the other hand, ciprofloxacin more effectively diminished the incidence of Gram-negative isolates. Yeasts were grown from the sputum of several patients before and during therapy. Their number did not increase during amoxycillin/clavulanate therapy while it increased under ciprofloxacin. The groups showed no significant differences with regard to sputum production, histamine concentration or lung function. The majority of patients (28/40) acknowledged improvement of their symptoms. There was no significant difference between the groups. On the basis of these results both amoxycillin/clavulanate and ciprofloxacin appear of similar value for treatment of patients with exacerbations of chronic bronchitis.

Topics: Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Chronic Disease; Ciprofloxacin; Clavulanic Acids; Drug Therapy, Combination; Female; Histamine; Humans; Male; Prospective Studies; Randomized Controlled Trials as Topic; Respiratory Function Tests; Sputum

Two treatments, pivmecillinam 200 mg plus pivampicillin 250 mg (Miraxid) given twice-daily and amoxycillin 250 mg plus clavulanic acid 125 mg (Augmentin) given three times daily were compared in two parallel groups of 388 general practice patients with acute bronchitis or acute exacerbations of chronic bronchitis. Patients with acute bronchitis (140 on Miraxid, 144 on Augmentin) received a 7-day course of treatment and those with acute exacerbations of chronic bronchitis (55 on Miraxid, 49 on Augmentin) a 10-day course of treatment. Both treatments were equally effective, with 99 (71%) patients with acute bronchitis being successfully treated with Miraxid and 107 (74%) with Augmentin. In acute exacerbations of chronic bronchitis, Miraxid was successful in 29 (53%) patients and Augmentin in 24 (49%) patients. Side-effects were reported by 26 (12%) of patients in both treatment groups. This single blind multicentre general practice study comparing twice-daily Miraxid with 3 times daily Augmentin demonstrated that both treatments were equally effective clinically and equally well tolerated.

Topics: Adult; Aged; Amdinocillin; Amdinocillin Pivoxil; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Bronchitis; Clavulanic Acids; Clinical Trials as Topic; Drug Administration Schedule; Drug Combinations; Family Practice; Female; Humans; Male; Middle Aged; Pivampicillin

Topics: Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; beta-Lactamase Inhibitors; beta-Lactams; Bronchitis; Clavulanic Acid; Clinical Trials as Topic; Doxycycline; Drug Combinations; Humans; Middle Aged

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Inflammatory Agents; Bronchitis; Cough; Female; Humans; Ibuprofen; Male; Sputum

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Inflammatory Agents; Bronchitis; Cough; Female; Humans; Ibuprofen; Male; Sputum

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Bronchitis; Humans; Ibuprofen; Treatment Outcome

Though general antibiotic consumption data is available, information on the actual patterns of prescribing antibiotics locally is difficult to obtain. An easy to use methodology was designed to assess ambulatory management of infections by Latvian general practitioners (GPs).. GPs were asked to record data in a patient data collection form for every patient that received antibiotics. Study period - (7 days) one week in November, 2008. Data recorded included the following details: an antibiotic, the prescribed dose, dosing interval, route of administration combined with the demographic factors of the patient and clinical diagnosis based on a pre-defined list.. Two hundred forty eight forms out of the 600 (41%) were returned by post. Antibiotics were prescribed in 6.4% (1711/26803) of outpatient consultations. In total, 1763 antibiotics were prescribed during the study period. Ninety seven percent of the patients received monotherapy and only 47 (2.7%) patients were prescribed two antibiotics. The most commonly prescribed antibiotics were amoxicillin (33.9% of prescribed), amoxicillin/clavulanate (18,7%) and clarithromycin (7.6%). The most commonly treated indications were pharyngitis (29.8%), acute bronchitis (25.3%) and rhinosinusitis (10.2%). Pneumonia was mostly treated with amoxicillin/clavulanate (25,7%), amoxicillin (15.7%) and clarithromycin (19.3%).. Methodology employed provided useful additional information on ambulatory practice of prescribing antibiotics and could be used in further assessment studies. Educational interventions should be focused on treatment of acute pharyngitis and bronchitis in children and unnecessary use of quinolones in adults for uncomplicated urinary tract infection.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Ambulatory Care; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bronchitis; Child; Child, Preschool; Clarithromycin; Drug Prescriptions; Female; General Practice; Humans; Infant; Latvia; Male; Middle Aged; Pharyngitis; Pneumonia; Practice Patterns, Physicians'; Sinusitis; Surveys and Questionnaires; Urinary Tract Infections; Young Adult

Topics: Acute Disease; Adrenal Cortex Hormones; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bronchitis; Bronchodilator Agents; Common Cold; Community-Acquired Infections; Comorbidity; Diagnosis, Differential; Drug Therapy, Combination; Dyspnea; Humans; Male; Middle Aged; Pneumonia, Bacterial; Pulmonary Disease, Chronic Obstructive

The recommended antibiotic prophylaxis by second-generation cephalosporins reduces the incidence of wound infection and empyema, but its effectiveness on postoperative pneumonias (POPs) after major lung resection lacks demonstration. We investigated risk factors and characteristics of POPs occurring when antibiotic prophylaxis by second-generation cephalosporin or an alternative prophylaxis targeting organisms responsible for bronchial colonization was used.. An 18-month prospective study on all patients undergoing lung resections for noninfectious disease was performed. Prophylaxis by cefamandole (3 g/24 h, over 48 hours) was used during the first 6 months, whereas amoxicillin-clavulanate (6 g/24 h, over 24 hours) was used during the subsequent 12 months. Intraoperative bronchial aspirates were systematically cultured. Patients with suspicion of pneumonia underwent bronchoscopic sampling for culture.. Included were 168 patients in the first period and 277 patients in the second period. The incidence of POP decreased by 45% during the second period (P = 0.0027). A significant reduction in antibiotic therapy requirement for postoperative infections (P = 0.0044) was also observed. Thirty-day mortality decreased from 6.5% to 2.9% (P = 0.06). Multivariate analysis showed that type of resection, intraoperative colonization, chronic obstructive pulmonary disease, gender, body mass index, and type of prophylaxis were independent risk factors of POP. A case control-study that matched patients of the two periods according to these risk factors (except for antibiotic prophylaxis) confirmed that the incidence of POP was lowered during the second period.. Targeted antibiotic prophylaxis may decrease the rate of POPs after lung resection and improve outcome.

Topics: Aged; Amoxicillin-Potassium Clavulanate Combination; Antibiotic Prophylaxis; Bronchitis; Case-Control Studies; Cefamandole; Cephalosporins; Dose-Response Relationship, Drug; Drug Administration Schedule; Education, Medical, Continuing; Female; Follow-Up Studies; France; Humans; Incidence; Lung Diseases; Male; Middle Aged; Multivariate Analysis; Pneumonectomy; Pneumonia, Bacterial; Postoperative Complications; Preoperative Care; Probability; Prospective Studies; Reference Values; Risk Assessment; Surgical Wound Infection; Survival Rate

The aim of work was the assessment of plasma anion oxalate (Ox) concentration in children during antibacterial treatment depending on way and time of antibiotic administration.. The examinations were carried out in 80 children, without nephrolithiasis, aged 10.1 +/- 4.3 years with bronchopneumonia, treated with beta-lactame antibiotics. The children were divided in two groups: I--children treated with oral amoxicillin + clavulanic acid or cefuroxime axetil (n=40), II--children treated with the same antibiotics intravenously (n=40). The Ox concentration in plasma and urine was measured using an enzymatic method with oxalate oxidase, four times. (0)--before treatment, (a)--in third day and (b)--in last day of administration (10 to 14 day), (c)--3 weeks after finishing treatment with antibiotics.. The result showed that in children before treatment (0) mean plasma Ox concentration was 2.439 +/- 0.645 micromol/l. In 3rd day (a) the Ox concentration increased to 7.848 +/- 0.999 micromol/l (p < 0.01), in last day of treatment (b) decreased to 5.681 +/- 0.871 micromol/l, and after 3 weeks (c) came back to initial values (p > 0.05). Intravenous antibiotics administration did not influence plasma Ox concentration.. Plasma oxalate concentration increases during oral administration of beta-lactame antibiotics caused by increased intestinal absorption, as a result of saprophytic microflora deterioration. However intravewous administration of the same antibiotics does not change the concentration of plasma oxalate.

Topics: Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anions; Anti-Bacterial Agents; beta-Lactamases; Bronchitis; Cefuroxime; Child; Child, Preschool; Female; Humans; Infant; Male; Oxalates; Pneumonia

Topics: Amoxicillin-Potassium Clavulanate Combination; Bronchial Spasm; Bronchitis; Child; Child, Preschool; Female; Humans; Male; Otitis Media; Tooth Discoloration

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; beta-Lactamase Inhibitors; beta-Lactamases; Bronchitis; Colony Count, Microbial; Community-Acquired Infections; Drug Resistance, Microbial; Drug Therapy, Combination; Humans; Opportunistic Infections; Pneumonia, Bacterial; Pneumonia, Pneumococcal; Respiratory Tract Infections; Streptococcus pneumoniae

Sixty outpatients at the age of 65 to 75 years with exacerbated chronic bronchitis were treated with antibiotics: amoxycillin/clavulanic acid (20 patients), cefaclor (20 patients) and ciprofloxacin (20 patients). The treatment course in all the cases was 5 days. Bacteriological tests of the sputum specimens and estimation of the isolate antibiotic susceptibility by the disk diffusion method were applied to all the patients before and after the treatment. 73 per cent of the patients had mixed infection. The microflora mainly included various species of streptococci highly susceptible to the drugs (54 per cent) as well as highly susceptible strains of pneumococci and hemophilic bacilli (33 and 17 per cent respectively). Atypical microflora was detected in 10 per cent of the cases. Pseudomonas aeruginosa strains were isolated in 2 cases. Acinetobacter sp. slightly susceptible only to ciprofloxacin was isolated in 1 case. Citrobacter sp. slightly susceptible to cefaclor and moderately susceptible to ciprofloxacin was detected in 1 case. Enterobacter sp. moderately susceptible only to ciprofloxacin was isolated in 1 case. A positive factor was moderate susceptibility of Proteus mirabilis to all the three drugs. In 24 patients (the average age of 54.7 years) the pharmacokinetics of ofloxacin administered under 2 different regimens was studied. The drug was used in a single dose of 400 mg once a day (group 1) or in a dose of 200 mg twice a day (group II) followed by estimation of the drug concentration in the blood and sputum. The pathogen eradication was stated in 61.5 and 72.7 per cent of the patients in groups I and II, respectively. By the results of the treatment with the use of the above mentioned antibiotics in the elderly patients fluoroquinolones should be considered preferable from the clinical and pharmacoeconomic viewpoints.

Topics: Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Area Under Curve; Bronchitis; Cefaclor; Cephalosporins; Chronic Disease; Ciprofloxacin; Cost-Benefit Analysis; Drug Therapy, Combination; Humans; Microbial Sensitivity Tests; Middle Aged; Ofloxacin; Penicillins

In a retrospective study, the clinical and microbiological efficacy of amoxycillin-clavulanic acid and ciprofloxacin were evaluated in outpatients observed within the previous year who were affected by acute purulent exacerbations of chronic bronchitis. Of the 95 patients included in the trial, 50 received amoxycillin 875 mg-clavulanic acid 125 mg 8-hourly for 10 days and 45 received ciprofloxacin 500 mg 12-hourly before meals for 10 days. Of the amoxycillin-clavulanic acid-treated patients, 90% showed clear clinical improvement and in 10% treatment failed. In the ciprofloxacin group, 75.5% of patients showed improvement and in 24.5% treatment failed. All pathogens isolated prior to therapy were susceptible to the antibiotic used for therapy. At the end of treatment, in the amoxycillin-clavulanic acid-treated group, 84% of strains were eradicated and 8% persisted; others were superinfections. In the ciprofloxacin group, 57.7% of strains were eradicated, 26.6% persisted and 15.5% were superinfections. No clinically significant side effects were observed in either group. Overall, amoxycillin-clavulanic acid demonstrated superior clinical and microbiological efficacy to ciprofloxacin, although this might be attributable to the higher proportion of aerobic Gram-negative pathogens in the ciprofloxacin group.

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Bronchitis; Chronic Disease; Ciprofloxacin; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Retrospective Studies

Topics: Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bronchitis; Clinical Trials as Topic; Female; Humans; Male; Middle Aged; Pneumonia, Bacterial; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Infections; Sputum

Twenty patients, all admitted to hospital with acute purulent exacerbations of chronic bronchitis associated with Haemophilus influenzae, Streptococcus pneumoniae or beta-lactamase producing Branhamella catarrhalis were treated twice daily for ten days with amoxycillin/clavulanate. Ten patients were first given 1000 mg amoxycillin with 200 mg potassium clavulanate intravenously bd for three days, before crossing to the standard oral regimen of 1000 mg amoxycillin + 250 mg potassium clavulanate bd. Clinical results on day 10 were excellent in 16/20 patients, but 14 patients developed recurrences or reinfections within a week of the end-of-treatment, five of them with beta-lactamase producing B. catarrhalis. Bacteriological and kinetic studies showed that the branhamella beta-lactamases were inhibited by 0.25 mg/l clavulanic acid and that the mean sputum concentration of clavulanic acid was 0.16 mg/l, that of amoxycillin being 0.92 mg/l. The importance of the follow-up of such infections is stressed.

Topics: Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; beta-Lactamase Inhibitors; Bronchitis; Chronic Disease; Clavulanic Acids; Drug Combinations; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Kinetics; Male; Middle Aged; Moraxella; Recurrence; Sputum; Streptococcal Infections; Streptococcus pneumoniae

Forty-five patients with acute chronic bronchitis were treated with Augmentin, an amoxycillin combined with the beta-lactamase inhibitor clavulanic acid, initially by parenteral administration followed by oral treatment after 3 days lasting in the mean 7.1 days. The over-all clinical evaluation showed a cure rate of 93%. Side-effects were comparable to therapy with other amoxycillins. Bacteriological evaluation of the sputum samples demonstrated in 91% of cases an elimination of the initially isolated organism. Prior to therapy we found in 25% of the isolated strains beta-lactamase-producing and Augmentin-sensitive organisms. The parenteral formulation of Augmentin seems to be a valuable addition to the parenteral therapy of lower respiratory tract infections.

Topics: Acute Disease; Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; beta-Lactamases; Bronchitis; Clavulanic Acids; Drug Combinations; Dyspnea; Female; Humans; Infusions, Parenteral; Male; Middle Aged; Sputum

Twenty-four patients with pulmonary infections (7 pneumoniae, 17 exacerbations of chronic bronchitis) were treated with a combination of 250 mg of amoxicillin and 125 mg of clavulanic acid supplemented by 500 mg of amoxicillin every eight hours. All patients showed good clinical, roentgenological, and bacteriological response. Bacteria were cleared from sputum by the third day of treatment in half of the patients and by the end of treatment in all but one of the others. Pathogens eradicated from sputum, with concurrent clinical cure, included gram-negative bacteria producing cephalosporinases shown to be resistant to the combination drug by both disk and minimal inhibitory concentration determinations.

Topics: Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; beta-Lactamases; beta-Lactams; Bronchitis; Clavulanic Acid; Drug Combinations; Humans; Microbial Sensitivity Tests; Middle Aged; Pneumonia