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A double-blind cross-over study was undertaken to compare the efficacy of amoxycillin and pivampicillin on Haemophilus influenzae infection of the lower respiratory tract in children. 20 patients with cystic fibrosis (CF) or chronic obstructive pulmonary disease (COPD) due to other causes were included in the study. All patients had a history of regularly harbouring H. influenzae in sputum and repeated treatment failures with pivampicillin. 18 completed two 14-day courses in random order with equimolar doses of pivampicillin (80 mg/kg/day) and amoxycillin (62 mg/kg/day). Both drugs were well tolerated with no serious side effects, but pivampicillin was associated with more pronounced nausea. In steady state the mean serum concentrations of antibiotics 2 and 4 h after medication were 9.7 and 3.7 micrograms/ml for pivampicillin and 19.1 and 7.9 micrograms/ml for amoxycillin (p less than 0.01). Eradication of H. influenzae and clinical improvement was seen in one-third of the courses with both drugs. Betalactamase producing ampicillin-resistant strains emerged during 58% of the amoxycillin courses, but only in 16% of the pivampicillin courses (p less than 0.001). The high number of treatment failures and the development of resistant strains indicate that betalactamase inhibitors may possibly improve the efficacy of these drugs, especially of amoxycillin, in these patients.
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PMID:A comparative study of amoxycillin and pivampicillin in persistent Haemophilus influenzae infection of the lower respiratory tract in children with chronic lung disease. 352 32

Twenty-one adult patients hospitalized with lower respiratory tract infections due to Branhamella catarrhalis or Haemophilus influenzae or both were treated with the combination of oral amoxicillin and potassium clavulanate (Augmentin) in an open, noncomparative clinical trial. Diseases included pneumonia, empyema, and exacerbations of bronchiectasis and chronic lung disease. Thirteen of 16 B. catarrhalis and six of nine H. influenzae isolates were beta-lactamase positive. The patients with B. catarrhalis were treated for a mean of 5.3 days, and those with H. influenzae were treated for a mean of 7.0 days. The overall response to therapy was excellent, with 18 of 19 beta-lactamase-producing strains eradicated on therapy. One patient secondarily infected with Pseudomonas aeruginosa was a clinical failure, and two patients with H. influenzae who became culture positive again after therapy were considered microbiologic failures. Gastrointestinal side effects (especially nausea) were common, although all patients completed a course of therapy. Sputum levels of amoxicillin were surprisingly low (less than 0.05 to 0.54 micrograms/ml), a finding which may explain the high relapse rate (22%) seen with H. influenzae, as these are below the usual MICs of amoxicillin for this organism. The combination of amoxicillin plus potassium clavulanate appears to be an excellent drug for treatment of beta-lactamase-producing strains of these two species, although mild gastrointestinal side effects are common.
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PMID:Amoxicillin-clavulanic acid in the treatment of lower respiratory tract infections caused by beta-lactamase-positive Haemophilus influenzae and Branhamella catarrhalis. 387 10

Three grams of amoxycillin administered twice daily for seven days, as an oral powder (Amoxil 3G sachets, Bencard) dispersed in water, to 17 patients with bronchiectasis resulted in striking clinical, spirometric and bacteriological improvement in 11 of 12 patients who were producing purulent sputum from which Haemophilus influenzae was cultured by a selective bacteriological technique (Roberts & Cole, 1980). In the five patients from whose sputum this organism could not be cultured, and in one from whom it could, there was no improvement. Untoward effects were limited to nausea in one patient and acceptability of the regimen by the remaining patients was unanimous. There was no evidence of accumulation of the drug in serum or sputum. The rapidity of effect and oral form of the treatment suggest that it may provide a simple out-patient regimen for chronic bronchial sepsis and severe purulent exacerbations of chronic bronchitis from which H. influenzae can be cultured.
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PMID:A simple oral antimicrobial regimen effective in severe chronic bronchial suppuration associated with culturable Haemophilus influenzae. 660 Nov 2

Twenty-three patients were treated with Augmentin for severe respiratory tract infections caused by beta-lactamase producing organisms. The success rate, clinically and bacteriologically, was 19 out of 23. One non beta-lactamase producing H. influenzae, and three mixed organisms including Staph aureus accounted for the four failures. The elimination of the organisms, sensitive to Augmentin were quick and clinical improvement was seen in 72 hours. The only side effects noted were nausea in three patients, which abated on taking the tablets with meals. Augmentin is a useful drug in the treatment of respiratory tract infection particularly in acute exacerbation of chronic bronchitis.
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PMID:Respiratory tract infections caused by beta-lactamase producing organisms treated with augmentin. 698 77

We compared the clinical and microbiological efficacy of dirithromycin with that of azithromycin in outpatients with acute bacterial exacerbations of chronic bronchitis who could be graded into stage III according to Ball's system of stratification. A total of 80 patients was studied. Of these, 40 were treated with dirithromycin as a once-daily dose of 500 mg for 5 days, and 40 with azithromycin as a once-daily dose of 500 mg for 3 days. At post-therapy, treatment success (cure or improvement) was achieved in 36 out of 40 (90%) patients receiving dirithromycin compared with 37 out of 40 (92.5%) in the azithromycin group. At the late post-therapy visit, 34 out of 36 (94.4%) dirithromycin-treated patients were cured as were 33 of 37 (89.2%) azithromycin-treated patients. A small proportion of patients treated with dirithromycin (10%) or with azithromycin (12.5%) suffered mild side effects. Gastrointestinal disorders, including abdominal cramps, nausea, or diarrhea, were common adverse effects. The main pathogens isolated before treatment were Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Eradication rates at the end of treatment were 90% (36 out of 40) for the dirithromycin group and 92.5% (37 out of 40) for the azithromycin group. Persistence of H. influenzae isolates was found in 3 out of 11 (27.3%) patients treated with dirithromycin and in 2 out of 9 (22.2%) who had received azithromycin. At the late post-therapy visit, eradication occurred in 34 out of 36 (94.4%) strains in the dirithromycin group and in 33 out of 37 (89.2%) in the azithromycin group. We conclude that dirithromycin and azithromycin appear to be equally effective in the treatment of acute bacterial exacerbations of chronic bronchitis.
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PMID:Comparative study of dirithromycin and azithromycin in the treatment of acute bacterial exacerbations of chronic bronchitis. 1032 42

Community-acquired pneumonia (CAP) remains a common and serious illness with approximately 2-4 million cases reported annually. Management of CAP is therapeutically challenging due to the increasing prevalence of penicillin- and macrolide-resistant pneumococci and beta-lactamase producing Haemophilus influenzae, as well as the increased recognition of 'atypical' pathogens, such as Chlamydia pneumoniae and Mycoplasma pneumoniae, and the frequent need for empiric therapy. We aimed to evaluate the safety and efficacy of moxifloxacin in the treatment of patients with CAP. To do this we carried out a prospective, uncontrolled, non-blind, Phase III clinical trial, in 27 U.S. centers. Patients included in the study were over 18 years of age with signs and symptoms of CAP confirmed by evidence of a new or progressive infiltrate on chest radiograph. The intervention used was moxifloxacin 400 mg PO once daily for 10 days. Sputum samples were collected pretherapy for Gram stain and culture for typical organisms. Culture and serological testing for Chlamydia pneumoniae and Mycoplasma pneumoniae was also performed. Susceptibility to moxifloxacin was determined by disk diffusion and MIC. Clinical and bacteriological responses were determined at the end of therapy (0-6 days post-therapy), follow-up (14-35 days post-therapy) and overall (end of therapy plus follow-up). Analyses were performed on both valid for efficacy and intent-to-treat populations. The primary efficacy variable was overall clinical resolution. Of 254 patients enrolled in the Study, 196 patients were included in the efficacy analyses. The majority of patients were male (58%) and Caucasian (85%) with a mean age of 49 years (range: 18 to 85 years). Only 3% of patients were hospitalized pretherapy. The most common pretherapy organisms identified, by culture or serology, in the valid for efficacy population (i.e. 147 organisms among 116 patients), were: Chlamydia pneumoniae (n=63; 54%), Mycoplasma pneumoniae (n=29; 25%), Streptococcus pneumoniae (n=14; 12%) and Haemophilus influenzae (n=13; 10%). End of therapy, follow-up and overall clinical resolution rates for the valid for efficacy population were 94%, 93% and 93%, respectively. The 95% CI for the overall clinical resolution rate was 88.1%, 95.9%. The overall bacteriological response for patients diagnosed by culture or serological criteria, was 91% (95% CI=84%, 96%). For patients who only met serological criteria for infection, the overall bacteriological response was 94% (60/64). Bacterial response rates for the four most commonly isolated pathogens were: 89% (56/63) for C. pneumoniae, 93% (27/29) for M. pneumoniae, 93% (13/14) for S. pneumoniae and 85% (11/13) for H. influenzae. Drug-related adverse events were reported in 33% (85/254) of moxifloxacin-treated patients. Nausea (9%), diarrhea (6%) and dizziness (4%) were the most commonly reported adverse events. Atypical organisms were isolated in high frequency among patients with CAP. Moxifloxacin 400 mg once daily for 10 days was effective and well-tolerated in the treatment of these adult patients with CAP. Moxifloxacin offers an effective treatment alternative for CAP due to both typical and atypical bacterial pathogens.
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PMID:Efficacy and safety of ten day moxifloxacin 400 mg once daily in the treatment of patients with community-acquired pneumonia. Community Acquired Pneumonia Study Group. 1071 13

Telithromycin is a new ketolide antimicrobial, specifically developed for the treatment of community-acquired respiratory tract infections. It has a wide spectrum of antibacterial activity against common respiratory pathogens including Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes. It also has activity against atypical pathogens, such as Chlamydia pneumoniae, Legionella pneumophila and Mycoplasma pneumoniae. Telithromycin maintains activity against beta-lactam and macrolide-resistant respiratory tract pathogens and does not appear to induce cross-resistance to other members of the macrolide-lincosamide-streptogramin (MLS) group of antimicrobials. It demonstrates bactericidal activity against S. pneumoniae and H. influenzae and has a prolonged concentration-dependent post-antibiotic effect (PAE) in vitro. The drug has favourable pharmacokinetics following oral administration. It is well absorbed, achieves good plasma levels and is highly concentrated in pulmonary tissues and white blood cells. In clinical trials, telithromycin given orally at a dose of 800 mg once daily for 5 - 10 days was as effective as comparator antimicrobials for the treatment of adults with community-acquired pneumonia, acute exacerbations of chronic bronchitis, acute maxillary sinusitis and group A-beta-haemolytic streptococcal pharyngitis or tonsillitis. The adverse events and safety profile were similar to comparator antimicrobials. The most common adverse events were diarrhoea, nausea, headache and dizziness. Telithromycin should provide an effective, convenient and well-tolerated once-daily oral therapy for treatment of respiratory infections.
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PMID:Telithromycin: a new ketolide antimicrobial for treatment of respiratory tract infections. 1117 47

Gatifloxacin is an 8-methoxy fluoroquinolone with broad activity against respiratory tract pathogens, including those commonly associated with community-acquired pneumonia (CAP). To evaluate the efficacy and safety of oral gatifloxacin 400 mg once daily for seven to 14 days, community-based physicians enrolled adult outpatients with confirmed or suspected CAP in a prospective, single-arm, open-label, noncomparative study. Of 1488 clinically evaluable patients with radiographically confirmed or clinically suspected CAP, 1417 (95.2%) were cured. All strains of Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, the most commonly isolated pathogens, were susceptible to gatifloxacin. Penicillin nonsusceptibility was seen in 32.6% of S. pneumoniae isolates, and beta-lactamase production was detected in H. influenzae (26.9%) and M. catarrhalis (88%) isolates. Clinical cure rates of 91%, 94%, and 92% were achieved in patients with S. pneumoniae, H. influenzae, and M. catarrhalis, respectively. All seven patients with fully penicillin-resistant S. pneumoniae (MIC > or =2 micro g/ml) were cured. Gatifloxacin was well tolerated, with the most common drug-related adverse events being nausea (2.8%) and diarrhea (1.7%). Gatifloxacin is effective and well tolerated as empiric therapy for CAP in the outpatient community setting.
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PMID:Oral gatifloxacin in outpatient community-acquired pneumonia: results from TeqCES, a community-based, open-label, multicenter study. 1237 37

In this multicentre, multinational, comparative, double-blind clinical trial, outpatients with both clinical signs and symptoms and radiographic evidence of acute sinusitis were randomly assigned to receive for 7 days either a twice-daily oral regimen of faropenem daloxate (300 mg) or a twice daily oral regimen of cefuroxime axetil (250 mg). Among 452 patients considered valid for clinical efficacy, faropenem daloxate treatment was found to be statistically equivalent to cefuroxime axetil (89.0% vs. 88.4%-95% CI=-5.2%; +6.4%) at the 7-16 days post-therapy assessment. At 28-35 days post-therapy, the continued clinical cure rate in the faropenem daloxate group was 92.6% and that for the cefuroxime axetil group was 94.9% (95% CI: -6.8%; +1.2%). A total of 148 organisms was obtained in 136 microbiologically valid patients (30.1%). The predominant causative organisms were Streptococcus pneumoniae (47.1%), Haemophilus influenzae (30.1%), Staphylococcus aureus (14.7%) and Moraxella catarrhalis (8.8%). The bacteriological success rate at the 7-16 days post-therapy evaluation was similar in both treatment groups: 91.5% and 90.8% in the faropenem daloxate and cefuroxime axetil groups, respectively (95% CI=-9.2%; +9.5%). Eradication or presumed eradication was detected for 97.3% and 96.3% of S. pneumoniae, 85.0% and 90.5% of H. influenzae, 88.9% and 90.9% of S. aureus and 100.0% and 83.3% of M. catarrhalis in faropenem daloxate and cefuroxime axetil recipients, respectively. At least one drug-related event was reported by 9.5% of the faropenem daloxate-treated patients and by 10.3% of those who received cefuroxime axetil. The most frequently reported drug-related events were diarrhoea (2.2% versus 2.9%), nausea/vomiting (1.5% vs. 0.7%), abdominal pain (0.7% vs 1.5%) and skin reactions (1.5% vs. 1.1%). Overall, faropenem daloxate was at least as effective clinically and bacteriologically as cefuroxime axetil and was well tolerated.
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PMID:Comparison of the efficacy and safety of faropenem daloxate and cefuroxime axetil for the treatment of acute bacterial maxillary sinusitis in adults. 1270 1

The objective of the study was to compare the clinical efficacy and bacteriological response of levofloxacin and amoxicillin/clavulanic acid (co-amoxiclav) in the treatment of purulent maxillary sinusitis. Sixty patients randomly received either levofloxacin 300 mg orally once daily (LEV group) or co-amoxiclav 625 mg three times a day (COA group) for 14 days. Thirty four patients were in the LEV group and 26 patients were in the COA group. The mean total symptom score was significantly decreased after treatment and was comparable between both groups. Radiological improvement was 61.8% in the LEV group (41.2% resolution, 20.6% improvement) and 61.5% in the COA group (26.9% resolution, 34.6% improvement). Pretreatment maxillary antral aspiration cultures were positive in 28 patients (82.4%) in the LEV group and 20 patients (76.9%) in the COA group. Bacteriological eradication was 78.5% in the LEV group and 70.0% in the COA group, which was not significantly different. In the LEV group, the eradication rate for major pathogens of acute sinusitis was 100% for H. influenzae (both betalactamase +ve and -ve), 100% for S. pneumoniae and S. aureus, 100% for Neisseria species, and 66.7% for P. aeruginosa. The eradication rate in the COA group was 75% for H. influenzae (both betalactamase +ve and -ve), 100% for S. pnumoniae and S. aureus, 50% for Neisseria species, and 0% for P. aeruginosa. There were no significant changes in vital sign measurements or hemato-biochemical parameters at the end of treatment as compared to baseline values, in both groups. Adverse events were found in 8.8% of patient in the LEV group and in 7.7% of patients in the COA group. Adverse events included nausea, abdominal pain, and diarrhea. All the adverse events in both groups were mild and resolved spontaneously. This study demonstrated that levofloxacin 300 mg orally once daily was as effective and safe as amoxicillin/clavulanic acid 625 mg three times a day in the treatment of maxillary sinusitis, either acute or acute exacerbation. Both drugs showed bacteriological efficacy that was not significantly different. The once daily dosage regimen is more applicable, convenience and has better compliance.
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PMID:An open label, randomized comparative study of levofloxacin and amoxicillin/clavulanic acid in the treatment of purulent sinusitis in adult Thai patients. 1507 30


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