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To assess the efficacy and safety of a single-dose therapy for acute uncomplicated cystitis (AUC), we compared 4 treatment regimens in 120 women. Patients eligible for the study were randomly assigned to one of four treatment groups: Ciprofloxacin (CPFX) 200 mg in a single oral dose (group A); 200 mg once daily for 3 days (group B); 200 mg twice daily for 3 day (group C); and cefpodoxime-proxcetil (CPDX-PR) 200 mg once daily for 3 days (group D). The efficacy was evaluated 3 days after the single-dose therapy or at the end of a three-day therapy according to the criteria proposed by the Japanese UTI Committee. The overall clinical efficacy in a total of 107 patients was evaluated to be excellent, moderate, and poor in 72 (67.3%), 35 (31.8%), and 1 (0.9%), respectively. The causative organisms were eradicated in 88.0, 85.2, 85.2, and 82.1% of the patients in groups A, B, C, and D, respectively. Recurrence was identified in 3 (2 in group A and one in group D) of 16 patients who were followed at 2 to 3 weeks after the treatment. No adverse reactions related to the antibiotics were recognized in the study. There were no significant differences in the clinical efficacy or recurrence rate among these four treatment regimens. These results indicate that the single-dose therapy of CPFX is the treatment of choice in women with AUC.
The care strategy of pharyngitis has been changed dramatically these last years. Because of evolution of antibiotic resistance, the attitude which prevailed of the systematic treatment of pharyngitis in order to prevent a hypothetical acute rheumatic fever, could not persist. Discrimination between pharyngitis due to group A streptococcus (GAS) and nonstreptococcal pharyngitis (usually of viral causes) cannot be made in a reliable way by the clinical signs and symptoms, even if clinical scores are used. The free availability to practitioners of GAS rapid diagnostic tests, sensitive (>90%) and specific (>95%), changes the rule by simplifying it: pharyngitis with positive test must be treated with antibiotics, those with negative test should not be received such treatment. A reduction of two thirds of antibiotics consumption for pharyngitis can be expected, while maintaining the benefit (improvement of the clinical signs, reduction of contagiousness and the complications) for the patients for whom it is necessary. Because of GAS resistance to macrolides and the absence of resistance to beta-lactam antibiotics, a compound belonging of this last family should be prescribed and for a short treatment duration: amoxicillin (50 mg/kg/j, b.i.d for 6 days), cefpodoxime proxetil (8 mg/kg/j b.i.d for 5 days), cefuroxime axetil (30 mg/kg/j b.i.d for 4 days).
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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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To determine the effect of protein binding on the pharmacokinetics and distribution from plasma to interstitial fluid (ISF) of cephalexin and cefpodoxime proxetil in dogs.
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An open-label, dose-response study of cefpodoxime proxetil (CPD), an expanded-spectrum cephalosporin, was conducted with 58 males with uncomplicated Neisseria gonorrhoeae infections with single doses of 600, 400, 200, 100, or 50 mg of CPD administered orally by tablet. CPD eradicated N. gonorrhoeae in all 50 evaluable patients (10 per group) at all doses studied. Eight of the isolates eradicated were beta-lactamase-producing organisms. Two patients reported three side effects, nausea, vomiting, and diarrhea, which were mild and resolved without intervention or sequelae. There were no clinically remarkable drug-related changes in vital signs or clinical laboratory assays. Results show that single oral doses of CPD are an effective and well-tolerated treatment for uncomplicated N. gonorrhoeae infection in males at doses as low as 50 mg.
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The risk for a child to carry penicillin-resistant S. pneumoniae (MIC > or = 0.125 mg/l) did not increase after antibiotic treatment: 84 of 364 (23.1%) before, 70 of 364 (19.2%) after. There was a significant decrease of penicillin-susceptible S. pneumoniae carriage, 117 of 364 (32.1%) before treatment compared with 24 of 364 (6.6%) (P = 0.0001) after treatment. However, among the children carrying S. pneumoniae at the end of the treatment there was an increase in the percentage of penicillin-resistant pneumococci: 84 of 201 (41.8%) before treatment and 70 of 94 (74.5%) after treatment. Among the 94 children carrying S. pneumoniae at the end of the treatment, 22 did not harbor pneumococcus before, 16 carried another genotypically different serotype and 56 harbored the same serotype. Among these 56 children 2 patients harbored strains that had increased MICs for the tested beta-lactam antibiotics. The randomly amplified polymorphic DNA analysis showed that in one case, the strains were genetically different.
Deciding whether an antibiotic is necessary, when to begin therapy and selecting an optimal drug is an everyday challenge in clinical practice. In vitro susceptibility testing which determines the minimum concentration necessary for a particular antibiotic to inhibit or kill most strains of a bacterial species and pharmacodynamic modeling are useful but have limitations. The need for antibiotic therapy for acute otitis media (AOM) has been recently questioned. However, explanations for uniformly positive results with many antibiotic and placebo comparative trials include overdiagnosis of AOM at study entry, inclusion of patients with mild or uncomplicated AOM and broad criteria for the definition of clinical success. Recurrent and persistent AOM does not have as favorable a natural history as uncomplicated AOM; children below 2 years of age benefit most from antibiotic therapy. Selecting the best choice among the many antibiotics that can be used to treat AOM has become more complex over the last decade due to escalating antibiotic resistance among the pathogens that cause this infection. Broader spectrum antibiotics such as cefdinir, the newly introduced third generation cephalosporin, have their most prominent use in the treatment of persistent and recurrent AOM. In the early 1950s and 1960s penicillin clearly was the best available agent for the treatment of group A streptococcal (GAS) infections. In the 1970s the situation began to change as cephalosporin antibiotics became available. Superior eradication rates with cephalosporins such as cefdinir have now been well-documented. The leading hypothesis to explain the widening gap in efficacy between penicillin and cephalosporins relates to two major concepts: the presence of copathogens and differential alteration of the normal microbial ecology in the throat as a consequence of the selected therapy. There are positive and negative consequences to early initiation of antibiotic therapy for GAS tonsillopharyngitis. Penicillin has persisting good efficacy in patients older than the age of 12 years and in those who have been ill for >2 days. Shortening therapy for GAS tonsillopharyngitis offers a therapeutic advantage. Cefpodoxime proxetil and cefdinir have a 5-day indication for the treatment of GAS tonsillopharyngitis. Antibiotics with lower side effect profile, infrequent dosing, good palatability in suspension formulation and efficacy with short duration of treatment may lead to better outcomes because noncompliance often results in failed therapy, persistence of infection and morbidity.
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Twenty nine children were treated with cefpodoxime proxetil (CPDX-PR, CS-807) and the clinical efficacy and side effects were evaluated. Ages of the patients ranged from 2 months to 10 years. Dose levels of CPDX-PR ranged from 7.5 to 12.0 mg/kg/day for 5 to 12.7 days. The 29 patients included 9 tonsillitis, 2 otitis media, 5 scarlet fever, 3 bronchopneumonia, 1 lymphadenitis, 8 urinary tract infections and 1 staphylococcal scalded skin syndrome, and they were evaluated for the clinical efficacy of CPDX-PR. Results were excellent in 21 and good in 8 patients. Out of the 29 patients, 3 cases showed diarrhea and 2 cases showed elevated GOT and GPT. The pharmacokinetics of CPDX-PR was studied in 9 patients whose ages ranged from 1 to 9 years. The serum peak concentrations of CPDX in 5 patients were between 1.37 and 4.10 micrograms/ml (mean: 2.53 micrograms/ml) at 1 to 6 hours after dosing 3 mg/kg before meals. Those of 4 patients ranged 3.29 to 4.88 micrograms/ml (mean: 4.36 micrograms/ml) at 2 hours after administering 6 mg/kg before meals. Portions of CPDX excreted into urine within 6 hours ranged from 20.3 to 34.3% (mean 27.1%) in 5 patients who were given 3 mg/kg, and ranged from 24.1 to 65.7% (mean 41.1%) in 4 patients given 6 mg/kg.
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In order to objectively evaluate the effectiveness, safety and usefulness of the new oral cephem cefpodoxime proxetil (CS-807, CPDX-PR) for the treatment of skin and soft tissue infections, a double-blind comparative study was undertaken using cefaclor (CCL) as the control drug. CPDX-PR and CCL were administered for 7 days at daily doses of 400 mg (divided into 2 portions) and 750 mg (divided into 3 portions), respectively. A total of 243 patients (118 in the CPDX-PR group and 125 in the CCL group) was treated in this study. The effectiveness, safety and usefulness were evaluated in 222 (106 in the CPDX-PR group and 116 in the CCL group), 234 (113 in the CPDX-PR group and 121 in the CCL group) and in 223 patients (107 in the CPDX-PR group and 116 in the CCL group), respectively. There were no differences in patients' backgrounds between the 2 groups, except for the presence or the absence of surgical treatments. The results we obtained are summarized below: 1. In the evaluation of clinical efficacy by the subcommittee, excellent, good, fair and poor efficacy were observed in 36, 43, 17 and 10 patients in the CPDX-PR group, respectively; the efficacy rate was, therefore, calculated to be 74.5%. As for the CCL group, respective results were observed in 50, 39, 17 and 10 patients, indicating an efficacy rate of 76.7%. There was no significant difference between the 2 groups. Improvement rates judged by physicians in charge were 80.2% in the CPDX-PR group and 88.8% in the CCL group. Moreover, no significant difference in diseases or severity were found between the 2 groups. 2. As for the bacteriological efficacy, the 2 groups showed high elimination rates, as 90.1% and 91.6% of the disease causing bacteria were eliminated in the CPDX-PR group and in the CCL group, respectively. Elimination rates in single infections with Staphylococcus aureus were determined to be 85.7% in the CPDX-PR group and 85.0% in the CCL group. 3. Although 6 patients in the CPDX-PR group and 2 patients in the CCL group developed side effects, which were mainly gastrointestinal symptoms, there was no significant difference in the incidence of side effects between the 2 groups. Abnormal laboratory values were found in 5 patients in the CPDX-PR group and 1 patient in the CCL group. 4. There was no significant difference in the usefulness between the 2 groups.(ABSTRACT TRUNCATED AT 400 WORDS)