cefpodoxime-proxetil and Otitis-Media

Acute otitis media (AOM) is diagnosed based on visualization of a full or bulging tympanic membrane with middle ear effusion. The distribution of bacteria causing AOM in North America under the influence of pneumococcal conjugate vaccination and antibiotic selection pressure has resulted in a predominance of β-lactamase-producing Haemophilus influenzae followed by penicillin-resistant Streptococcus pneumoniae. Although guidelines continue to endorse amoxicillin as the preferred treatment, amoxicillin/clavulanate in high dosage would be the preferred treatment based on the otopathogen mix currently. Antibiotic prophylaxis has fallen into disfavor as a preventative strategy for AOM recurrences.

Topics: Age Factors; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cefdinir; Cefpodoxime Proxetil; Ceftizoxime; Cefuroxime; Cephalosporins; Child; Child, Preschool; Haemophilus influenzae; Humans; Infant; Microbial Sensitivity Tests; Moraxella catarrhalis; Otitis Media; Otitis Media with Effusion; Otoscopy; Streptococcus pneumoniae; Time Factors; Tympanic Membrane

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

To discuss the chemistry, pharmacokinetics, spectrum of activity, clinical trials, adverse effects, drug interactions, and dosage guidelines of cefpodoxime proxetil.. Literature was identified through a MEDLINE search from 1988 to the present and from review of bibliographies in that literature.. Data were limited to comparative trials published in the English literature. Although many studies were conducted in Japan, the results often were available only in Japanese or partly in English. As these studies could not be completely evaluated, they are not included in this review.. Cefpodoxime exhibits good activity against many gram-positive and gram-negative organisms. In clinical trials, cefpodoxime was similar in both clinical and bacteriologic efficacy to amoxicillin, cefaclor, amoxicillin/clavulanate, and penicillin in the treatment of respiratory and urinary tract infections. It also appeared effective in the treatment of skin and soft tissue infections, although no comparative trials have been performed. Cefpodoxime is well tolerated by children and is effective in the treatment of otitis media and pharyngitis. It has a similar adverse effect profile to that of other penicillins and cephalosporins, with gastrointestinal effects being most common.. Cefpodoxime demonstrates good in vitro activity against pathogens frequently associated with respiratory tract, urinary tract, and skin and tissue infections. It has not demonstrated greater efficacy than the other antibiotics to which it has been compared. The available published clinical trials are fraught with methodologic, statistical, and evaluative flaws. Thus, further trials comparing cefpodoxime with established treatments, as well as the newer cephalosporins, are needed before its place in therapy can be established.

Topics: Administration, Oral; Age Factors; Bacterial Infections; Cefpodoxime Proxetil; Ceftizoxime; Clinical Trials as Topic; Drug Interactions; Female; Humans; Male; Otitis Media; Respiratory Tract Infections; Skin Diseases, Infectious; Urinary Tract Infections

Topics: Adult; Bacterial Infections; Cefpodoxime Proxetil; Ceftizoxime; Child; Humans; Microbial Sensitivity Tests; Otitis Media; Pharyngitis; Respiratory Tract Infections; Urinary Tract Infections

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

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

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

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

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

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefpodoxime Proxetil; Ceftizoxime; Child; Clavulanic Acids; Drug Therapy, Combination; Humans; Otitis Media; Prodrugs; Treatment Outcome