Between October, 1993, and March, 1994, we conducted a clinical trial comparing cefpodoxime-proxetil and amoxicillin-clavulanate in acute otitis media. From 364 children, 4 months to 4.5 years old, a nasopharyngeal sample was obtained before and after treatment. Antibiotic susceptibility was established by determining minimal inhibitory concentrations by the agar dilution method. Serotype and randomly amplified polymorphic DNA analysis were used to compare pre- and posttreatment S. pneumoniae strains.
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Eighteen patients undergoing thoracotomy for suspected pulmonary neoplasia were given 200 mg cefpodoxime equivalent by mouth, before operation. Plasma samples were obtained before dose administration, and plasma and lung tissue samples were obtained at the time of operation which was 3, 6 or 12 h after the dose. All samples were assayed for cefpodoxime. The mean ratios for lung tissue/plasma concentrations were similar between 3 and 12 h after dose, suggesting that equilibrium between plasma and lung tissue concentrations was reached within 3 h of medication. The mean concentrations of cefpodoxime in lung tissue were 0.63 +/- 0.16, 0.52 +/- 0.09 and 0.19 +/- 0.02 mg/kg at 3, 6 and 12 h after administration, respectively. These observations indicate good, rapid and sustained penetration into lung tissue in concentrations greater than or equal to the MIC90 for most common micro-organisms found in community-acquired pneumonia.
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Clinical studies of cefpodoxime proxetil (CPDX-PR), a new cephem antibiotic, were carried out in 60 patients in the pediatric field. The overall efficacy rate on 54 patients with various infections was 98.1%, and few side effects, all of them very mild, were developed in 6 of 60 patients (10%). It was concluded that CPDX-PR was one of the most useful antibiotics in the pediatric field because of the high efficacy rate and the safety.
As the post-marketing surveillance of cefpodoxime proxetil (Banan), MICs of cefpodoxime (CPDX, an active form of Banan) against 1090 clinical isolates of 22 species from 15 medical institutions all over Japan from June 2000 to March 2001 were measured using the broth microdilution method approved by the Japanese Society of Chemotherapy and compared with those of oral cephem antibacterials, cefaclor, cefdinir, cefditoren, and cefcapene. In this study, remarkable change in the activity of CPDX was observed in Streptococcus pneumoniae and Haemophilus influenzae compared with the susceptibility in the studies before Banan was launched. This cause is considered to be the increase in the incidence of the following resistant strains: penicillin-intermediate S. pneumoniae (47.3%), penicillin-resistant S. pneumoniae (PRSP, 15.1%), and beta-lactamase-negative ampicillin-resistant (BLNAR) H. influenzae (24.0%), which were scarcely isolated in 1989 when Banan was launched. Other tested drugs also exhibited low activity against these resistant strains. However, CPDX showed comparatively good activity with MIC90 of 2 micrograms/mL against PRSP. Against methicillin-susceptible Staphylococcus spp., Streptococcus pyogenes, Streptococcus agalactiae, and Moraxella catarrhalis, CPDX also showed comparatively good activity with MIC90 of < or = 4 micrograms/mL, which was almost equal to that in the studies before its marketing. Against quinolones-resistant Neisseria gonorrhoeae, CPDX showed excellent activity with MIC90 of 0.5 microgram/mL. Against members of the family Enterobacteriaceae except for Citrobacter freundii, Enterobacter spp., Proteus vulgaris, and Morganella morganii, CPDX showed good activity. However, in Escherichia coli, Klebsiella spp. Proteus spp., and Providencia spp., there are some high-resistant strains to all tested drugs including CPDX. Against Peptostreptococcus spp., MIC90 of CPDX was 8 micrograms/mL and its MIC range was widely distributed from 0.03 to 32 micrograms/mL, which were similar to those in the studies before its marketing. In this study, CPDX showed the decrease in the activity against several species as did other drugs tested, but against most of species tested, CPDX maintained good activity. Furthermore, it is necessary to pay much attention to the trend of resistant strains.
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The clinical efficacy of cefditoren pivoxil (CDTR-PI) was evaluated for 43 pediatric patients with acute otitis media or acute sinusitis. The causative organisms were identified and their susceptibilities to 6 oral beta-lactam antibiotics were measured; ampicillin (ABPC), cefaclor (CCL), cefdinir (CFDN), cefditoren pivoxil (CDTR-PI), cefteram pivoxil (CFTM-PI) and cefpodoxime proxetil (CPDX-PR). The ages of 43 patients were distributed from 4 months to 10 years and 7 months, and especially children under 4 years accounted for 72% (31 cases). In 22 cases (51%), Haemophilus influenzae or Streptococcus pneumoniae were identified as the pathogens, but in 18 cases, no causative organisms were defined. Treatment by CDTR-PI was successful in 12 cases out of 15 evaluable cases in which H. influenzae or S. pneumoniae were identified as the main causative organisms. From the susceptibility testing of them, some strains of H. influenzae were found to be ABPC-resistant and some strains of S. pneumoniae were benzylpenicillin (PCG)-resistant. To support above clinical evaluation of CDTR-PI, susceptibility testings on clinically isolated H. influenzae (81 strains) and S. pneumoniae (79 strains) were performed using above mentioned 6 oral beta-lactam antibiotics. The MIC80s against H. influenzae were; CDTR-PI 0.06 microgram/ml, CCL 2 micrograms/ml, CPDX-PR 0.125 microgram/ml, CFTM-PI 0.03 microgram/ml, CFDN 1 microgram/ml and ABPC 1 microgram/ml. Those against S. pneumoniae were; CDTR-PI 0.5 microgram/ml, CCL > 4 micrograms/ml, CPDX-PR 2 micrograms/ml, CFTM-PI 1 microgram/ml, CFDN 2 micrograms/ml and ABPC 1 microgram/ml. From those results, it was concluded that CDTR-PI or CFTM-PI may be preferable for the treatment of acute otitis media and acute sinusitis in children.
122 patients with bacterial infections of respiratory tract, ear, nose, and throat, urinary tract and skin and soft tissue were treated with cefpodoxime proxetil. In the treatments of patients with clinical efficacy tates of cefpodoxime proxetil for infections in these four systems were 90.0%, 97.5%, 90.0% and 86.4%, respectively. The bacterial clearance rate of gram-positive bacterial was 96.9%, and that of gram-negative bacteria 96.4%. Adverse drug reaction rate was 18.9%.
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The linear regression analysis data for the calibration plots showed good linear relationship, with r(2) = 0.998 ± 0.0015 with respect to peak area in the concentration range of 100-600 ng per spot. The mean value±SD of slope and intercept were 3.38 ± 1.47 and 986.9 ± 108.78 with respect to peak area. The method was validated for precision, recovery, and robustness. The limits of detection and quantification were 3.99 and 12.39 ng per spot, respectively. Cefpodoxime proxetil was subjected to acid and alkali hydrolysis, oxidation, and thermal degradation. The drug undergoes degradation under acidic and basic conditions, indicating that the drug is susceptible to both acid and base. The degraded product was well resolved from the pure drug, with significantly different R(f) value. Statistical analysis proves that the method is repeatable, selective, and accurate for the estimation of the investigated drug.
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The antimicrobial activity of cefpodoxime, the active metabolite of the new cephalosporin ester cefpodoxime proxetil, in comparison to cefixime, cefotiam, cefuroxime, and cefotaxime was determined against a broad spectrum of freshly isolated gram-positive and gram-negative bacterial strains. Cefpodoxime was demonstrated to be inhibitory at concentrations of less than or equal to 1 mg/l against 90% of strains of Moraxella catarrhalis, Haemophilus influenzae, Escherichia coli (beta-lactamase- negative strains), Klebsiella spp., Serratia spp., Proteus mirabilis, Proteus vulgaris, Providencia spp., and Salmonella spp. This antimicrobial activity of cefpodoxime was generally superior to that of cefuroxime and similar to that of cefixime. Cefpodoxime was active at less than or equal to 1 mg/l against 50% of the members of beta-lactamase-producing Escherichia coli, Enterobacter cloacae, Enterobacter aerogenes, Citrobacter spp., and Morganella morganii. Cefpodoxime proved to be highly inhibitory against group A, B, and G streptococci and Streptococcus pneumoniae (MIC90 less than 0.015 mg/l). The MICs of cefpodoxime and those of the other cephalosporins were less than 2 mg/l for greater than or equal to 90% of the strains of Staphylococcus aureus and Staphylococcus epidermidis, with the exception of cefixime which had no activity with MICs below 8 mg/l against these bacteria. Pseudomonas spp., Acinetobacter spp., and Enterococcus spp. were resistant to cefpodoxime. The antibacterial activity of cefpodoxime was only to a minor degree influenced by different growth conditions with the exception of high inoculum sizes against some beta-lactamase producing strains of gram-negative bacilli.(ABSTRACT TRUNCATED AT 250 WORDS)
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Analysis of restriction fragment-length polymorphism of ribosomal DNA regions (ribotypes) was used as an epidemiologic tool to compare 25 pre- and posttreatment strains obtained from 12 patients treated with either cefpodoxime proxetil or amoxicillin-clavulanic acid. Ribotyping is a promising method to differentiate relapse from reinfection in the treatment failures of Escherichia coli urinary tract infections.