cefpodoxime-proxetil and Acute-Disease

Cefpodoxime proxetil is an oral third generation cephalosporin with a broad spectrum of antibacterial activity. The drug has in vitro activity against many common Gram-positive and Gram-negative pathogens associated with common paediatric infections, making the drug a useful option for empirical therapy. In randomised controlled trials conducted in children with acute otitis media, oral cefpodoxime proxetil 8 to 10 mg/kg/day (usually administered in 2 divided doses) for 5 to 10 days was at least as effective as standard regimens of amoxicillin/ clavulanic acid, cefixime, cefuroxime axetil or cefaclor as assessed by either clinical or bacteriological criteria. Cefpodoxime 8 to 10 mg/kg/day (administered in 2 divided doses) for 5 to 10 days was at least as effective as standard 10-day regimens of penicillin V in the treatment of children with pharyngitis and/or tonsillitis. Significant differences in favour of cefpodoxime proxetil were demonstrated in terms of clinical (1 study) and bacteriological (2 studies) criteria. The clinical efficacy of 5 days of treatment with cefpodoxime proxetil is similar to that of 10 days of treatment with penicillin V. In children with lower respiratory tract infections (primarily pneumonia), clinical and bacteriological efficacy rates achieved with cefpodoxime proxetil treatment were similar to those produced by cefuroxime axetil or amoxicillin/clavulanic acid in randomised controlled trials. Cefpodoxime proxetil also demonstrated clinical efficacy in paediatric patients with skin and soft tissue infections. In randomised studies that included both adults and children with a variety of infections (e.g. abscess, atheroma, furuncle and carbuncle, infected wounds, cellulitis), cefpodoxime proxetil showed efficacy similar to that of cefuroxime axetil or cefaclor. Cefpodoxime proxetil is well tolerated by paediatric patients, with adverse events (primarily gastrointestinal tract disturbances and skin rashes) that are consistent with those reported for other oral cephalosporins.. Cefpodoxime proxetil is a third generation cephalosporin with a broad spectrum of antibacterial activity and a favourable pharmacokinetic profile which allows twice-daily administration. It is generally well tolerated and demonstrates good bacteriological and clinical efficacy in paediatric patients with various infectious diseases, including acute otitis media, tonsillitis and/or pharyngitis. Based on these characteristics, cefpodoxime proxetil is a suitable option for the treatment of paediatric patients with various common bacterial infections.

Topics: Acute Disease; Adolescent; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Cefpodoxime Proxetil; Ceftizoxime; Child; Child, Preschool; Humans; Infant; Microbial Sensitivity Tests; Otitis Media; Prodrugs; Tissue Distribution

Although it varies from country to country, there is a worrying worldwide increase in antibiotic resistance among pathogens causing otitis. This has led to a search for therapeutic alternatives to the reference treatment, which is still amoxicillin in many countries. Cefpodoxime proxetil is one such alternative. Six comparative randomized trials of cefpodoxime proxetil in childhood acute otitis media have been published or presented at international conferences. They involved a total of 1188 patients, 658 of whom received cefpodoxime proxetil and 530 of whom received the comparator drug (amoxicillin/clavulanic acid in 3 trials, cefaclor in 1, and cefixime in 2); duration of treatment varied from 5 days for cefpodoxime proxetil to 10 days for amoxicillin/clavulanic acid, and the age of the children included ranged from 2 months to 12 years. The clinical efficacy of cefpodoxime proxetil was at least equivalent to that of the comparators in 4 trials and significantly better in 2 trials. Firstly, in one study vs. amoxicillin/clavulanic acid, the superiority of cefpodoxime proxetil (8 mg/kg/day twice daily) in terms of healing at the end of treatment and in terms of the number of normal tympanograms at the follow-up visit was shown. Secondly, in a study performed by our group, vs. cefixime, cefpodoxime proxetil (8 mg/kg/day twice daily) showed a better healing rate at the end of treatment in febrile and painful acute otitis media. The microbiologic and pharmacokinetic data show that cefpodoxime proxetil is one of the most active compounds against Haemophilus influenzae and Streptococcus pneumoniae.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefpodoxime Proxetil; Ceftizoxime; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Haemophilus influenzae; Humans; Infant; Microbial Sensitivity Tests; Otitis Media; Prodrugs; Randomized Controlled Trials as Topic; Streptococcus pneumoniae; Treatment Outcome

The aim was to demonstrate the equivalence of the clinical efficacy and safety of cefpodoxime-proxetil (200 mg bid for 5 days) to that of amoxicillin-clavulanic acid (1 g/125 mg bid for 8 days) in adults with acute maxillary sinusitis.. In this prospective, multicenter, centrally-randomized, open-label study, 73 general practitioners and 11 ear, nose, and throat specialists included 512 patients with unilateral acute maxillary sinusitis.. The clinical success rates at day 12-19 in the per-protocol population (primary analysis) were 92.3% (215/233) in the cefpodoxime-proxetil group and 93.6% (204/218) in the amoxicillin-clavulanic acid group. The 95% confidence interval of [6.5%; 3.9%] demonstrated that cefpodoxime-proxetil was not inferior to amoxicillin-clavulanic acid. Cure rates at follow-up (day 25-30) were 90.6% and 92.7%, respectively. Results were similar in the intent-to-treat population. Compliance was significantly better in the cefpodoxime-proxetil group (99.2% versus 95.5%; p=0.011). Tolerance was also significantly better: 1.2% (3/247) of cefpodoxime-proxetil patients reported a treatment-related adverse event, compared with 10.7% (26/244) in the amoxicillin-clavulanic acid group (p<0.001). Most events were gastrointestinal and of mild to moderate intensity.. In this study, a 5-day course of cefpodoxime-proxetil at 200 mg bid was as clinically effective as amoxicillin-clavulanic acid 1 g/125 mg bid for 8 days with a significantly better safety profile and compliance.

Topics: Acute Disease; Adolescent; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefpodoxime Proxetil; Ceftizoxime; Confidence Intervals; Enzyme Inhibitors; Female; Follow-Up Studies; Humans; Male; Maxillary Sinusitis; Patient Compliance; Patient Selection; Prospective Studies; Time Factors; Treatment Outcome

One hundred sixty-three women with uncomplicated acute lower urinary tract infections were included in a multicenter randomized study comparing cefpodoxime-proxetil (one 100-mg tablet twice daily) with trimethoprim-sulfamethoxazole (one double-strength tablet [160/800 mg] twice daily) for 3 days. A total of 30 women in both arms were excluded from the study for various reasons. At 4 to 7 days after the discontinuation of therapy, 62 of 63 (98.4%) cefpodoxime-proxetil recipients and 70 of 70 (100%) trimethoprim-sulfamethoxazole patients were clinically cured and demonstrated bacteriological eradication, respectively. At 28 days after treatment, 48 of 55 (87.3%) and 43 of 50 (86%) cefpodoxime-proxetil recipients as well as 51 of 60 (85%) and 42 of 50 (84%) trimethoprim-sulfamethoxazole recipients were clinically cured and demonstrated bacteriological eradication, respectively. Independently of the prescribed regimen, a significant difference (P < 0.001) in failure rates was observed only for patients with a previous history of three or more episodes of acute cystitis per year. With the exception of one patient in the trimethoprim-sulfamethoxazole arm who discontinued therapy because of gastrointestinal pain, both antimicrobials were well tolerated. In conclusion, cefpodoxime-proxetil treatment for 3 days was as safe and effective as trimethoprim-sulfamethoxazole for 3 days for the treatment of uncomplicated acute cystitis in women.

Topics: Acute Disease; Adolescent; Adult; Aged; Anti-Bacterial Agents; Cefpodoxime Proxetil; Ceftizoxime; Cystitis; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Middle Aged; Prospective Studies; Treatment Outcome; Trimethoprim, Sulfamethoxazole Drug Combination

Many publications in recent years have argued in favor of shortened therapy for acute otitis media. However, doubt persists regarding children younger than 2 years, and some authors therefore restrict short course therapy to children older than 2 years.. In a prospective, comparative, double blind, randomized, multicenter trial we compared cefpodoxime-proxetil, 8 mg/kg/day in two divided doses for 10 days, with an identical 5-day regimen followed by a 5-day placebo period.. Between October, 1996, and April, 1997, 450 children (mean age, 14.3 months) were enrolled, 227 in the 5-day group and 223 in the 10-day group. In the per protocol analysis clinical success was obtained on Days 12 to 14 after the beginning of treatment (main analysis) in 175 (84.1%) of the 208 children receiving the 5-day regimen and 194 (92.4%) of the 210 children receiving the 10-day regimen (P = 0.009). The superiority of the standard regimen was more marked among children cared for outside their homes (92.5% vs. 81.5%). Clinical success persisted on Days 28 to 42 among 134 (85.4%) of the 157 assessable patients in the 5-day group and 144 (83.7%) of the 172 assessable patients in the 10-day group (P = 0.68).. The 10-day regimen resulted in a higher success rate at the conclusion of therapy, but there were no differences between the two study groups 4 to 6 weeks after enrollment in the study protocol.

Topics: Acute Disease; Anti-Bacterial Agents; Cefpodoxime Proxetil; Ceftizoxime; Child, Preschool; Double-Blind Method; Drug Administration Schedule; Female; Haemophilus influenzae; Humans; Infant; Male; Moraxella catarrhalis; Multivariate Analysis; Otitis Media; Prodrugs; Prospective Studies; Serotyping; Streptococcus pneumoniae; Treatment Outcome

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.

Topics: Acute Disease; Adolescent; Adult; Aged; Anti-Infective Agents; Cefpodoxime Proxetil; Ceftizoxime; Ciprofloxacin; Cystitis; Drug Administration Schedule; Drug Evaluation; Female; Humans; Middle Aged; Prodrugs

An open-labeled and randomized trial was conducted to compare the efficacy and safety of once daily cefpodoxime proxetil suspension (10mg/kg/day) and thrice daily cefaclor (45mg/kg/day) in the treatment of acute otitis media in children. A total of 57 children aged from 6 months to 9 years were enrolled; 23 were treated with cefpodoxime and 34 with cefaclor. Satisfactory clinical outcome, either cure or improvement, was achieved at the end of treatment in 90% of patients in the cefaclor group and 95% of patients in the cefpodoxime group (p > 0.05). Clinical recurrence was identified at the follow-up visits in one case of the cefaclor group (3%), and none in the cefpodoxime group (p > 0.05). These drugs were well tolerated by 14/21 (67%) in the cefpodoxime-treated group and 27/32 (84%) in the cefaclor-treated group. The incidence of adverse events was slightly higher in the cefpodoxime group than in the cefaclor group, however the difference did not reach statistical significance (p > 0.05). The daily cost of once-daily cefpodoxime was lower than that of thrice-daily cefaclor. We conclude that cefpodoxime administered once daily is as effective and safe as cefaclor administered thrice daily in the treatment of acute otitis media in children. The less dosing frequency and lower daily price of cefpodoxime provide additional benefits.

Topics: Acute Disease; Cefaclor; Cefpodoxime Proxetil; Ceftizoxime; Cephalosporins; Child; Child, Preschool; Drug Administration Schedule; Female; Humans; Infant; Male; Otitis Media; Suspensions

Acute otitis media is the leading reason for antibiotic prescriptions in childhood. The increase in antibiotic resistance of Streptococcus pneumoniae is generally attributed to the extensive use of antibiotics and the selective pressure on the bacterial strains of the nasopharyngeal flora.. To evaluate the change in nasopharyngeal carriage of S. pneumoniae during antibiotic therapy prescribed for acute otitis media.. 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.. 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.. These data illustrate that antibiotic therapy did not increase the rate at which children carried penicillin-resistant S. pneumoniae, but there was an increase in the rate of resistance among the children carrying pneumococci at the end of the treatment, mainly as a result of reduction of susceptible strains.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefpodoxime Proxetil; Ceftizoxime; Child, Preschool; Clavulanic Acids; Female; Humans; Infant; Male; Nasopharynx; Otitis Media; Penicillin Resistance; Prospective Studies; Streptococcus pneumoniae

A multicentre open-label, randomised trial was performed to compare the efficacy and safety of cefpodoxime proxetil bd and cefaclor tds in the treatment of acute otitis media in children. A total of 167 children aged from 1 month to 11 years were enrolled in five centres: 78 treated with cefpodoxime and 83 treated with cefaclor, were evaluated in the ITT analysis. After tympanocentesis and culture of middle ear fluid, a pathogen was isolated from 85 (53%) of the 161 evaluable patients for the ITT analysis. The organisms isolated were as follows: Streptococcus pneumoniae: (n = 33, 37.5%); Haemophilus influenzae: (n = 22, 25%); Staphylococcus aureus: (n = 15, 17.1%); Streptococcus pyogenes: (n = 8, 9.1%); Moraxella catarrhalis: (n = 2, 2.3%); others (n = 6, 6.8%). Success (defined as a satisfactory clinical outcome, either cure or improvement) was achieved at the end of treatment, in 93.6% of ther patients in the cefpodoxime group and 91.6% of the patients in the cefaclor group (P> 0.05). Clinical recurrence was identified at the follow-up visit (30 days after inclusion), in 6.4% of the cefpodoxime-treated patients and 7.2% of the cefaclor-treated patients (P> 0.05). The drugs were well tolerated by 78/79 (99%) of patients in the cefpodoxime-treated group and 80/85 (94%) in the cefaclor-treated group. The incidence of adverse effects was higher in the cefaclor group than in the cefpodoxime group, but this was not statistically significant (P > 0.05). IN conclusion, cefpodaxime proxetil administered bd is as effective as cefaclor administered tds in the treatment of acute otitis media in children. The less frequent dosing schedule of cefpodoxime (bd) compared with cefaclor (tds) appears to be more convenient for the treatment of the infections in children.

Topics: Acute Disease; Cefaclor; Cefpodoxime Proxetil; Ceftizoxime; Cephalosporins; Child; Child, Preschool; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Male; Moraxella catarrhalis; Neisseriaceae Infections; Otitis Media; Prodrugs; Staphylococcal Infections; Staphylococcus aureus; Streptococcal Infections; Streptococcus pneumoniae; Streptococcus pyogenes; Suspensions

Although it varies from country to country, there is a worrying worldwide increase in antibiotic resistance among pathogens causing otitis. This has led to a search for therapeutic alternatives to the reference treatment, which is still amoxicillin in many countries. Cefpodoxime proxetil is one such alternative. Six comparative randomized trials of cefpodoxime proxetil in childhood acute otitis media have been published or presented at international conferences. They involved a total of 1188 patients, 658 of whom received cefpodoxime proxetil and 530 of whom received the comparator drug (amoxicillin/clavulanic acid in 3 trials, cefaclor in 1, and cefixime in 2); duration of treatment varied from 5 days for cefpodoxime proxetil to 10 days for amoxicillin/clavulanic acid, and the age of the children included ranged from 2 months to 12 years. The clinical efficacy of cefpodoxime proxetil was at least equivalent to that of the comparators in 4 trials and significantly better in 2 trials. Firstly, in one study vs. amoxicillin/clavulanic acid, the superiority of cefpodoxime proxetil (8 mg/kg/day twice daily) in terms of healing at the end of treatment and in terms of the number of normal tympanograms at the follow-up visit was shown. Secondly, in a study performed by our group, vs. cefixime, cefpodoxime proxetil (8 mg/kg/day twice daily) showed a better healing rate at the end of treatment in febrile and painful acute otitis media. The microbiologic and pharmacokinetic data show that cefpodoxime proxetil is one of the most active compounds against Haemophilus influenzae and Streptococcus pneumoniae.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefpodoxime Proxetil; Ceftizoxime; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Haemophilus influenzae; Humans; Infant; Microbial Sensitivity Tests; Otitis Media; Prodrugs; Randomized Controlled Trials as Topic; Streptococcus pneumoniae; Treatment Outcome

In order to evaluate the clinical efficacy and tolerance of cefpodoxime proxetil, compared with that of amoxicillin in the treatment of acute bacterial maxillary sinusitis, a randomized, double-blind, parallel group comparative study was performed. A total of 286 adults patients were included at 12 centres, each treatment group consisting of 143 patients. Each patient was treated for 10 days and observed before and after treatment. The observations included clinical, roentgenological, bacteriological and laboratory examinations. At inclusion, the most common pathogens were Haemophilus influenzae (24%) and Streptococcus pneumoniae (17%). In the per protocol analysis, 117 patients in the cefpodoxime group and 113 in the amoxicillin group were evaluable for clinical efficacy. The clinical response rates were 96% and 91%, respectively. The corresponding figures in the intent-to-treat analysis were 130 and 128 patients, with clinical response rates of 93% and 88%, respectively. Cefpodoxime proxetil proved clinically as effective as amoxicillin in the treatment of acute bacterial maxillary sinusitis. It was more effective in eradicating H. influenzae and was more efficient in improving the radiological score. Adverse events were reported in 20% of cefpodoxime cases and in 16% of amoxicillin cases. There was no statistically significant difference between the groups.

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin; Cefpodoxime Proxetil; Ceftizoxime; Cephalosporins; Double-Blind Method; Drug Evaluation; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Male; Maxillary Sinusitis; Middle Aged; Penicillins; Pneumococcal Infections; Prodrugs; Streptococcus pneumoniae; Treatment Outcome

One hundred and fifty female patients with acute uncomplicated cystitis were given 200 mg of CPDX-PR twice daily for 3-7 days to evaluate both its overall clinical efficacy and its adverse effects. In 82 cases (Group I) in which it was administered for 3 days, the overall clinical efficacy, evaluated by the criteria proposed by the Japanese UTI committee, was excellent in 64 cases, moderate in 17 and poor in one, with the effective rate being 98.8%. In 35 cases (Group II) in which it was administered for 4-7 days, the overall clinical efficacy was excellent in 18 cases, moderate in 15 and poor in 2, with the effective rate being 94.3%. The overall clinical evaluation was not performed in another 33 cases because they were given CPDX-PR for more than 8 days or 300 mg/day. Subjective adverse effects such as hoarseness and lingual inflammation were observed in only one of the 150 cases, but they disappeared spontaneously after the cessation of administration of CPDX-PR. These findings suggest that CPDX-PR is one of the most effective and safe antibiotic in the treatment of acute uncomplicated cystitis.

Topics: Acute Disease; Adolescent; Adult; Aged; Cefpodoxime Proxetil; Ceftizoxime; Cystitis; Female; Humans; Male; Middle Aged

A total of 260 children, 3 months to 11 years old (median age 24 months), with acute otitis media (AOM) received either cefpodoxime proxetil (CP) 8 mg/kg/d b.i.d. or amoxicillin/clavulanic acid (ACA) 40/10 mg/kg/d t.i.d. for 8 days. A significant difference in clinical cure rates was observed between the CP group 71/118 (60%) and the ACA group 42/105 (40%), p = 0.003. At the follow-up visit (20-30 days after the start of treatment), significant advantages were recorded with the CP vs. ACA therapy, in terms of satisfactory clinical response [90/111 (81%) vs 60/94 (63.8%), p = 0.005] residual middle ear effusion (14.4% vs 28.7%, p = 0.01) and normal tympanometry (78% vs 61.4%, p = 0.017). Compliance and adverse event frequency were the same in both treatment groups. The higher clinical cure rate and equivalent safety profile of CP indicates that it is an acceptable alternative to ACA for the treatment of AOM in children.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefpodoxime Proxetil; Ceftizoxime; Child; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Patient Compliance; Prodrugs; Treatment Outcome

To compare the use of once-a-day cefpodoxime proxetil to once-a-day cefixime in the treatment of acute suppurative otitis media.. Randomized, multicenter, investigator-blinded.. Outpatient.. A total of 368 patients (age 2 months to 17 years) were randomized to receive either cefpodoxime or cefixime in a 2:1 ratio (245 cefpodoxime, 123 cefixime); 236 patients (155 cefpodoxime, 81 cefixime) were evaluable for drug efficacy.. Patients received either cefpodoxime proxetil oral suspension (10 mg/kg/day, once daily for 10 days) or cefixime oral suspension (8 mg/kg/day, once daily for 10 days).. Clinical evaluations were performed before treatment (study day 1), at an interim visit (study day 3 through 6), at the end of therapy (study day 12 through 15), and at final follow-up (study day 25 through 38). Microbiologic evaluations were performed at enrollment and whenever appropriate thereafter.. End-of-therapy clinical cure rates in evaluable patients were 56% for the cefpodoxime group and 54% for the cefixime group. Clinical improvement rates were 27% for both groups. Clinical response rates were not significantly different between treatment groups (P = .541; 95% confidence interval = -8.1%, 15.2%). At long-term follow-up, 17% of patients in the cefpodoxime group and 20% in the cefixime group had a recurrence of infection. Drug-related adverse events (eg, diarrhea, diaper rash, vomiting, rash) occurred in 23.3% of cefpodoxime-treated patients and 17.9% of cefixime-treated patients (P = .282).. These findings suggest that cefpodoxime proxetil administered once daily is as effective and safe as cefixime given once daily in the treatment of acute suppurative otitis media in pediatric patients.

Topics: Acute Disease; Adolescent; Anti-Infective Agents; Cefixime; Cefotaxime; Cefpodoxime Proxetil; Ceftizoxime; Child; Child, Preschool; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media, Suppurative; Prodrugs; Statistics as Topic; Treatment Outcome

The clinical efficacy was examined for the newly developed oral cephem antibiotic, cefpodoxime proxetil (CPDX-PR) dry syrup, in the treatment of various acute infections in the field of pediatrics. CPDX-PR dry syrup was administered at 10 mg/kg/day in 3-divided doses to 535 children at 21 institutions, including Tottori University Hospital and its related hospitals. The efficacy rate of this drug was determined to be 80.8%. Among isolates, Staphylococcus aureus and Streptococcus sp. were highly susceptible to the drug, whereas Haemophilus influenzae showed relatively poor susceptibility. Side effects were observed in 2.80% of all of the patients, and abnormal laboratory findings were detected in 1.87%. The low incident of side effects demonstrated its high safety, and this drug was considered to be very useful for such pediatric infections as acute tonsillitis, acute pharyngitis and acute bronchitis.

Topics: Acute Disease; Administration, Oral; Adolescent; Bacterial Infections; Cefpodoxime Proxetil; Ceftizoxime; Child; Child, Preschool; Female; Humans; Infant; Male

In this multicenter, observer-blinded study, 301 patients with signs and symptoms of acute bacterial exacerbation of COPD were randomized (2:1) to receive either cefpodoxime proxetil (200 mg, bid) or cefaclor (250 mg, tid) for 10 days. Clinical and microbiologic evaluations were performed before treatment, during therapy (study days 3 to 5), at the end of therapy (3 to 7 days posttreatment), and at long-term follow-up (4 weeks posttreatment). The most common pretreatment isolates were Haemophilus influenzae, Haemophilus parainfluenzae, and Streptococcus pneumoniae. Significantly (p < 0.001) more bacterial isolates were susceptible in vitro to cefpodoxime (233 of 256, 91 percent) than to cefaclor (215 of 255, 84 percent). There were no statistically significant differences between the two drug regimens in eradication of the initial pathogen (cefpodoxime, 116 of 128, 91 percent; cefaclor, 59 of 64, 92 percent) or end-of-therapy clinical response (cure + proved; cefpodoxime, 99 of 100, 99 percent; cefaclor, 45 of 49, 92 percent) rates for evaluable patients. Both drug treatments were well-tolerated, with a similar incidence of drug-related adverse events (cefpodoxime 11 percent, cefaclor 12 percent). Cefpodoxime (bid) was as safe and effective as cefaclor (tid) in the treatment of acute exacerbation of COPD. The less frequent dosing regimen of cefpodoxime may improve patient compliance compared to those antibiotics that require three or four daily doses.

Topics: Acute Disease; Adult; Aged; Bacteria; Cefaclor; Cefpodoxime; Cefpodoxime Proxetil; Ceftizoxime; Drug Tolerance; Female; Humans; Lung Diseases, Obstructive; Male; Microbial Sensitivity Tests; Middle Aged; Prodrugs; United States

In a multicenter, randomized, investigator-blinded trial, patients were randomly selected to receive either cefpodoxime proxetil or amoxicillin-clavulanate potassium orally for the treatment of acute suppurative otitis media. Patients were seen before, during, and at the end of therapy, and 2 to 3 weeks after completion of therapy. A total of 229 patients, 153 receiving cefpodoxime and 76 receiving amoxicillin-clavulanate were entered into the study; all patients were examined to determine drug safety. A total of 146 patients, 98 in the cefpodoxime group and 48 in the amoxicillin-clavulanate group, completed the study and were examined to determine drug efficacy. End-of-therapy microbiologic eradication rates in assessable patients were 92% for cefpodoxime and 86% for amoxicillin-clavulanate (p = 0.14; 95% confidence interval (CI) on difference: -4.4%, 19.2%). End-of-therapy clinical response rates for assessable patients were as follows: cured, 68% for cefpodoxime and 65% for amoxicillin-clavulanate; improved, 24% for cefpodoxime and 23% for amoxicillin-clavulanate; and failed, 8% for cefpodoxime and 13% for amoxicillin-clavulanate (p = 0.57; 95% CI: -8.4%, 16.5%). Recurrence rates at long-term follow-up were 24% for cefpodoxime-treated patients and 25% for those given amoxicillin-clavulanate. Both drugs were well tolerated; 20.9% of those given cefpodoxime and 31.6% of amoxicillin-clavulanate-treated patients had drug-related adverse medical events (p = 0.102; 95% CI: -23.9%, 2.6%). Gastrointestinal complaints were the most frequently reported drug-related side effect in both groups: 11.8% of cefpodoxime-treated patients and 21.1% of those given amoxicillin-clavulanate (p = 0.076; 95% CI: -20.8%, 2.2%). Drug-related dermatologic side effects (e.g., diaper rash, pruritus, urticaria) were reported in 7.8% of cefpodoxime-treated patients and 14.5% of those who received amoxicillin-clavulanate (p = 0.160; 95% CI: -16.6%, 3.3%). Our findings suggest that clinical efficacy for cefpodoxime administered twice daily is equivalent to that of amoxicillin-clavulanate administered three times a day.

Topics: Acute Disease; Adolescent; Amoxicillin; Bacteria; Cefpodoxime Proxetil; Ceftizoxime; Child; Child, Preschool; Ear; Female; Humans; Infant; Male; Otitis Media, Suppurative; Prodrugs; Treatment Outcome

Pathogenic bacteria were isolated from 90% of patients with acute otitis media. This higher-than-expected rate of positive cultures was probably related to the meticulous bacteriologic techniques used.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteria; Bacteriological Techniques; Cefixime; Cefotaxime; Cefpodoxime Proxetil; Ceftizoxime; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Haemophilus influenzae; Humans; Infant; Moraxella catarrhalis; Otitis Media; Prodrugs; Punctures; Recurrence; Single-Blind Method; Streptococcus pneumoniae; Tympanic Membrane

The efficacy and tolerance of cefpodoxime proxetil were compared with those of cefaclor in a multicentre, international, prospective, double-blind, placebo-controlled study in adult outpatients suffering from acute sinusitis. At the end of treatment, cefpodoxime proxetil was more effective than cefaclor, producing complete clinical cure in 84% of cases (102/122) vs 68% of cases (77/114) in the cefaclor group (P = 0.01). The overall clinical efficacy (cure + improvement) was similar in the two groups with 95% (116/122) satisfactory responses in the cefpodoxime proxetil group and 93% (106/114) in the cefaclor group. Bacteriological response was similar with 95% eradication in the cefpodoxime proxetil group (55/58) vs 91% with cefaclor (63/69).

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Cefaclor; Cefpodoxime Proxetil; Ceftizoxime; Female; Humans; Immunodiffusion; Male; Middle Aged; Prodrugs; Remission Induction; Sinusitis

In 2011, new guidelines on antibiotic prescription for acute otitis media (AOM) were published in France to decrease the use of third generation cephalosporins that promote the carriage of extended-spectrum beta-lactamase producing Escherichia coli. Our objective was to assess the impact of the 2011 French recommendations on the type of antibiotics prescribed for AOM.. Fourteen thousand six hundred and sixty-one children, 6 to 24 months of age, presenting with AOM were included in 2 studies, between November 1, 2009 and October 31, 2012. The first one was conducted with the support of 62 private practice pediatricians; the second one was conducted in 7 pediatric emergency departments. Three periods of 1 year each were defined.. Antibiotics were prescribed in 12,471 (85.1%) of cases of AOM during the study period. Amoxicillin prescriptions was multiplied by 25, between the first year (2.6%) and the last year (66.1%). Conversely, prescriptions of cefpodoxime proxetil and amoxicillin-clavulanic acid decreased from 33.6% and 62.0% in the first year to 5.2% and 27.7% in the last year, respectively. This trend was observed in both private practices and in the pediatric emergency departments.. Amoxicillin became the most frequently prescribed antibiotic for AOM in 2012, complying with the 2011 French guidelines, while the proportion of prescribed broad-spectrum antibiotics decreased. Our study highlights the importance of guidelines to decrease the prescription of broad-spectrum antibiotics, a crucial factor in the prevention of antibiotic resistance.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefpodoxime Proxetil; Ceftizoxime; Child, Preschool; Drug Resistance, Microbial; Drug Utilization; Emergency Service, Hospital; France; Guideline Adherence; Humans; Inappropriate Prescribing; Infant; Multicenter Studies as Topic; Otitis Media; Pediatrics; Practice Guidelines as Topic; Practice Patterns, Physicians'; Private Practice

We report a case of acute interstitial nephritis (AIN) and immune hemolytic anemia (IHA) associated with cefpodoxime therapy.. A patient with a recent history of cefpodoxime proxetil treatment presented with elevated serum creatinine, oliguria, nausea, vomiting, and dyspnea. Evidence of renal failure, abnormal urinalysis, and renal biopsy with inflammatory infiltrate in the interstitium confirmed a diagnosis of AIN. The patient subsequently developed IHA, which was confirmed by peripheral blood smear results and positive Coombs' test. The patient recovered after dialysis therapy and 2 days of intravenous methylprednisolone (500mg/day) followed by oral prednisolone (60 mg/day), which was rapidly tapered and stopped within 3 weeks.. To our knowledge, cefpodoxime-induced AIN and IHA are unprecedented. Physicians should be aware that drug-induced AIN and hemolysis can be associated with cefpodoxime proxetil.

Topics: Acute Disease; Adult; Anemia, Hemolytic, Autoimmune; Anti-Bacterial Agents; Cefpodoxime Proxetil; Ceftizoxime; Female; Glucocorticoids; Humans; Methylprednisolone; Nephritis, Interstitial; Prednisolone; Renal Dialysis

Cefpodoxime proxetil (CPDX-PR, CS-807) was given orally to 18 children with acute bacterial infections including 10 with acute tonsillitis, 3 with acute bronchitis, 1 with pneumonia, 3 with staphylococcal scalded skin syndrome and 1 with infectious impetigo. Daily dosages per kg bodyweight ranging from 7.5 to 18 mg were given in 2 or 3 divided doses per day for 5 to 15 days. Clinical responses were excellent in 3 (16.7%), good in 11 (61.1%), fair in 4 (22.2%) and poor in 0 (0%), with an overall efficacy rate of 77.8%. Good bacteriological responses were obtained in 6 out of the 7 cases from which pathogens were identified. No side effect was observed. The above results suggest that CPDX-PR is a useful new oral cephalosporin derivative for the treatment of bacterial infections in children.

Topics: Acute Disease; Administration, Oral; Adolescent; Bacterial Infections; Bronchitis; Cefpodoxime Proxetil; Ceftizoxime; Chemical Phenomena; Chemistry; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male; Staphylococcal Scalded Skin Syndrome; Tonsillitis

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.

Topics: Acute Disease; Administration, Oral; Adolescent; Bacteria; Bacterial Infections; Cefpodoxime Proxetil; Ceftizoxime; Chemical Phenomena; Chemistry; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Pneumonia; Tonsillitis; Urinary Tract Infections

Children with acute infections were treated with cefpodoxime proxetil (CPDX-PR, CS-807), a new oral cephalosporin. 1. A girl of 4 years old, weighing 17 kg, and another girl of 12 years old, weighing 33 kg, were administered orally each 3 mg/kg of CPDX-PR. Blood levels of CPDX reached peaks of 1.39 and 2.26 micrograms/ml at 4 hours-post-dose, and T1/2's were 2.09 and 2.63 hours, respectively. Cumulative urinary recovery rates for 8 hours were 57.3 and 80.9%, respectively. 2. A total of 30 patients was treated with CPDX-PR. These patients included 10 with acute tonsillitis, 6 with acute bronchitis, 5 with bronchopneumonia, 2 with scarlet fever and 2 with urinary tract infections, and one each with acute pneumonia, acute otitis media, acute otitis media plus sweat gland abscess, staphylococcal scalded skin syndrome and acute lymphadenitis. The treatment was effective in 27 cases out of 29 (except one with an unknown response) with a clinical efficacy rate of 93.1%. 3. Bacteriological responses to CPDX-PR were as follows; eradication of pathogen in 7, and unknown in 2 out of 9 cases from whom pathogens had been isolated prior to the treatment. 4. As a side effect, diarrhea was observed in 1 patient, but it was possible to continue the treatment. With regard to laboratory tests, a slight elevation of GOT and slight elevations of GOT and GPT were found in 1 case each.

Topics: Absorption; Acute Disease; Administration, Oral; Bacterial Infections; Bronchitis; Bronchopneumonia; Cefpodoxime Proxetil; Ceftizoxime; Chemical Phenomena; Chemistry; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male; Tonsillitis

Pharmacokinetic and clinical evaluation of cefpodoxime proxetil (CPDX-PR, CS-807) were performed in the field of pediatrics. The obtained results are summarized as follows. 1. Peak serum concentrations of CPDX upon single oral doses of 3.0 mg/kg and 4.4 mg/kg of CPDX-PR were 1.26-1.46 micrograms/ml and 1.45 micrograms/ml, respectively, achieved at 4 hours and 1 hour after administration. Urinary excretion rates for CPDX in the first 8 hours ranged between 28.1 and 30.2%. 2. Clinical efficacy rates for pediatric infections obtained at single dose levels ranging 3 to 6 mg/kg were 97.5%, and that at a single dose of 1 mg/kg were 90.9%. 3. Bacteriological effectiveness was determined in 45 strains identified in recent cases. Eradication rates for these bacteria at dose levels of 3 to 6 mg/kg and 1 mg/kg were 91.3% and 95.5%, respectively. 4. No side effect nor abnormal laboratory test data were found in any of the cases examined. From these results, CPDX-PR appeared to be a useful antibiotic agent in the field of pediatrics.

Topics: Acute Disease; Administration, Oral; Bacteria; Bacterial Infections; Bronchitis; Cefpodoxime; Cefpodoxime Proxetil; Ceftizoxime; Chemical Phenomena; Chemistry; Child; Child, Preschool; Drug Evaluation; Drug Resistance, Microbial; Female; Humans; Infant; Male; Scarlet Fever; Tonsillitis