cefuroxime-axetil and Otitis-Media

Studies evaluating short-course therapy have focused on prevalent infections with demonstrable aetiology. Metaanalyses of clinical trials demonstrate that uncomplicated acute otitis media in children can be successfully treated with a 5-day course of cefuroxime axetil. In the treatment of tonsillopharyngitis, 4 - 5-day courses of oral cephalosporins compared favourably with the standard 10-day penicillin V regimen. The clinical cure rate and the bacteriological eradication rate were both significantly higher for cephalosporins than for penicillin V. Bacteriological failure rates for cephalosporins were about half those for penicillin. In studies on acute bacterial exacerbations of chronic bronchitis, no difference in the clinical cure rates or relapse rates was found between short-course therapy using cephalosporins and standard courses. The short courses had the advantage of improved gastrointestinal tolerance compared with longer durations of treatment. The results suggest that new short-course dosing regimens are viable and may be favourable in terms of increased tolerability, reduction in healthcare costs, enhanced patient compliance and the control of the development of antibiotic resistance.

Topics: Anti-Bacterial Agents; Bronchitis; Cefuroxime; Cephalosporins; Drug Administration Schedule; Humans; Otitis Media; Palatine Tonsil; Pharyngitis

Poor compliance with standard antibiotic regimens of 7 - 10 days' duration used in the treatment of acute upper respiratory tract infections contributes significantly to treatment failure. Patients fail to complete the recommended course of treatment, stopping once symptoms have resolved, which is typically within 2 - 5 days. Accumulating evidence from a large number of prospective clinical studies suggests that shortened courses of treatment may be as, or more, effective than conventional regimens of longer duration. As an example, a study comparing 5 days of cefuroxime axetil therapy with either 10 days of cefuroxime axetil or amoxycillin/clavulanate showed no differences in rates of clinical cure, bacteriological eradication and recurrence in paediatric patients with either acute otitis media or sinusitis. Shortened-course therapy with agents such as cefuroxime axetil has the potential to improve patient compliance and so reduce the rate of clinical failure and the emergence of resistant strains. Other potential benefits include fewer side-effects, improved patient satisfaction and lower treatment costs.

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Cefuroxime; Clavulanic Acid; Drug Administration Schedule; Drug Prescriptions; Drug Resistance, Microbial; Humans; Otitis Media; Sinusitis; Time Factors

To evaluate if the extent of normal microflora disturbances differed between treatment with amoxycillin-clavulanate administered in an active form and cefuroxime axetil administered as an inactive prodrug.. Twenty-eight children, 0.5-5 years old, diagnosed with acute otitis media (AOM), were treated with either amoxycillin-clavulanate (13.3 mg/kg 3 times daily) or cefuroxime axetil (15 mg/kg twice daily) for 7 days. Saliva samples and nasopharyngeal swabs were collected before, directly after and 2 weeks after treatment. The saliva samples were quantitatively and qualitatively analyzed and the nasopharyngeal swabs were qualitatively analyzed. All isolated strains were tested for beta-lactamase production.. Both treatment regimens gave rise to similar alterations of the normal oropharyngeal microflora. In both groups, the amount of Streptococcus salivarius was significantly reduced (P < 0.05). The most common causative pathogens of acute otitis were S. pneumoniae, Haemophilus influenzae and Moraxella catarrhalis. On the day of enrollment, approximately half of the patients, in both groups, were infected with more than one pathogen. The rate of infection or colonization with more than one potential pathogen was low on day 7 but recurred 2 weeks after treatment to similar levels as on day 0. The total number of patients with reinfection, recolonization or recurrence of pathogens on day 21 was 11/12 in the amoxycillin-clavulanate group and 4/7 in the cefuroxime axetil group. The most common beta-lactamase producer was M. catarrhalis.. The local high concentration of antibiotics in the oropharynx immediately after intake of antibiotic suspensions seem to have little or no impact on the extent of disturbance of the microflora in this region. Children of this age group seem prone to either reinfection, recolonization or persistence of pathogens within 2 weeks after treatment. Furthermore, co-infection with more than one pathogen seems common in children with AOM and infection with beta-lactamase producing microorganisms occurs frequently.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; beta-Lactamases; Cefuroxime; Cephalosporins; Child, Preschool; Colony Count, Microbial; Drug Therapy, Combination; Female; Humans; Infant; Male; Nasopharynx; Otitis Media; Prodrugs; Prospective Studies; Saliva

Topics: Biomarkers; Cefaclor; Cefuroxime; Cephalosporins; Child; Humans; Otitis Media; Prodrugs; Random Allocation

Bacteriologic response to cefuroxime axetil and cefaclor administered for 10 days was evaluated in acute otitis media (AOM) in patients aged 6-36 months. Middle ear fluid culture was obtained by tympanocentesis before treatment, on day 4 or 5 after initiation of treatment, and if clinical relapse occurred before day 17. Bacteriologic failure was observed in 32% of patients receiving cefaclor versus 15% of patients receiving cefuroxime axetil (P = .009). Failure rates increased with increasing MIC: For Streptococcus pneumoniae, 0.5 microg/mL (established as cutoff value for cefuroxime by the National Committee for Clinical Laboratory Standards [NCCLS]) discriminated between success and failure. For Haemophilus influenzae, high failure rates were observed for cefaclor, even with low MICs (< or = 1.0 microg/mL), and with both drugs they tended to increase with increasing MIC, even for values below the cutoff suggested by the NCCLS (8.0 and 4.0 microg/mL for cefaclor and cefuroxime, respectively). Thus, for AOM caused by H. influenzae, lower susceptibility cutoff levels for MICs should be established.

Topics: Acute Disease; Administration, Oral; Cefaclor; Cefuroxime; Cephalosporins; Child, Preschool; Female; Haemophilus influenzae; Humans; Infant; Male; Microbial Sensitivity Tests; Otitis Media; Streptococcus pneumoniae

In recent years there has been considerable interest in reducing the duration of antibiotic treatment regimens in patients with common bacterial infections. We conducted two independent, investigator-blinded, multicenter, randomized clinical trials, one of which included microbiologic evaluation of middle ear fluid obtained by tympanocentesis, comparing the efficacy and safety of 5 or 10 days of treatment with cefuroxime axetil suspension (CAE) with that of 10 days of treatment with amoxicillin/clavulanate suspension (AMX/CL) in children with acute otitis media.. A total of 719 pediatric patients from the ages of 3 months to 12 years were enrolled in the 2 studies. Patients received CAE for either 5 or 10 days at 30 mg/kg/day in 2 divided doses (n = 242 and 235, respectively) or AMX/CL for 10 days at 40 mg/kg/day in 3 divided doses (n = 242). Patients in the CAE (5 days) group received placebo on Days 6 through 10. In the study that included tympanocentesis, bacteriologic assessments were based on middle ear fluid cultures obtained pretreatment and, when possible, after treatment in patients with an unsatisfactory clinical outcome.. Organisms were isolated from the pretreatment middle ear fluid specimens of 177 of 244 (73%) patients undergoing tympanocentesis, with the primary pathogens being Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis (37, 35 and 12% of isolates, respectively). Pathogens were eradicated or presumed to be eradicated in 92% (24 of 26), 84% (32 of 38) and 95% (36 of 38) of bacteriologically evaluable patients treated with CAE for 5 or 10 days or with AMX/CL, respectively. A satisfactory clinical outcome (cure or improvement) occurred in 69% (101 of 147), 70% (121 of 173) and 74% (131 of 177) of clinically evaluable patients treated with CAE (5 days), CAE (10 days) or AMX/CL, respectively. Treatment with AMX/CL was associated with a significantly higher incidence of drug-related adverse events than was treatment with CAE for either 5 or 10 days (P < 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal adverse events (34% vs. 17 and 12%, respectively; P < 0.001), particularly diarrhea.. Treatment with CAE given twice daily for 5 days is equivalent to treatment for 10 days either with the same regimen of CAE or with AMX/CL given three times daily in pediatric patients with acute otitis media.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefuroxime; Child; Child, Preschool; Clavulanic Acids; Confidence Intervals; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Prodrugs; Prospective Studies; Suspensions; Treatment Outcome

Penicillin resistance of Streptococcus pneumoniae, one of the most common causes of acute otitis media, has recently increased and is now highly prevalent in many regions. However, its contribution to clinical failure still must be proved. Because the role of antibiotics in acute otitis media is to eradicate the pathogens present in the middle ear fluid, we conducted a randomized controlled study to determine bacterial eradication of pathogens in acute otitis media by two commonly used oral cephalosporins, cefuroxime axetil (30 mg/kg/day) and cefaclor (40 mg/kg/day).. Patients 6 to 36 months old with pneumococcal otitis media seen in the Pediatrics Emergency Room were studied. An initial middle ear fluid culture was obtained at enrollment, and a second culture was obtained on Day 4 or 5 during treatment. Follow-up was done also on Days 10, 17 and 42 after initiation of treatment. In cases of clinical relapse a third culture was obtained.. In total 78 patients were enrolled, 41 in the cefuroxime axetil group and 37 in the cefaclor group. Of the 78 S. pneumoniae isolates 31 (40%) were intermediately penicillin-resistant (MIC 0.125 to 1.0 microgram/ml). Of the 47 patients with penicillin-susceptible organisms 3 (6%) had bacteriologic failure vs. 4 of 19 (21%) and 7 of 11 (64%) of those with MIC of 0.125 to 0.25 microgram/ml and 0.38 to 1.0 microgram/ml, respectively (P < 0.001). For intermediately resistant pneumococci, in 7 of 12 (58%) of those receiving cefaclor the isolate was not eradicated vs. only 4 of 19 (21%) of those receiving cefuroxime axetil (P = 0.084). MIC to the administered cephalosporin of > 0.5 microgram/ml was associated with bacteriologic failure. Clinical failure was observed in 9 of 14 (64%) patients with bacteriologic failure vs. 10 of 52 (19%) patients with bacteriologic eradication (P = 0.003).. Intermediately penicillin-resistant S. pneumoniae is associated with an impaired bacteriologic and clinical response of acute otitis media to cefaclor and cefuroxime axetil. This effect was more pronounced with cefaclor than with cefuroxime axetil.

Topics: Acute Disease; Administration, Oral; Cefaclor; Cefuroxime; Cephalosporins; Child, Preschool; Drug Resistance, Microbial; Humans; Infant; Microbial Sensitivity Tests; Otitis Media; Penicillin Resistance; Pneumococcal Infections; Prospective Studies; Streptococcus pneumoniae

Cefuroxime axetil was evaluated for clinical efficacy and tolerance in the treatment of acute otitis media in children. Fifty-five children, 5.0 to 10.8 years, were randomly assigned to receive 250mg cefuroxime axetil every 12 hours or 50mg/kg/day amoxicillin in three divided doses. Both treatment schemes lasted for 10 days. Acute otitis media was diagnosed by the presence of erythema and/or opacity with bulging of the tympanic membrane. A tympanogram was obtained upon enrollment to the study, as well as within 2 days after completion of therapy. Fifty-one children completed the treatment protocol. The cure rate was 74.1% for cefuroxime axetil and 75.0% for amoxicillin. Clinical improvement was noted in 25.9% of children treated with cefuroxime axetil and in 25.0% of those treated with amoxicillin. There was no clinical failure in the two treatment groups. None of the children experienced relapse of acute otitis media during the month following completion of therapy. The findings indicate that cefuroxime axetil given twice daily has comparable efficacy to amoxicillin given three times daily in the treatment of children with acute otitis media.

Topics: Acute Disease; Amoxicillin; Cefuroxime; Child; Child, Preschool; Female; Humans; Male; Otitis Media; Otitis Media with Effusion; Prodrugs; Prospective Studies

A total of 110 adults with acute ear, nose and throat infections were treated orally with 750 mg/day (n = 9) or 1500 mg/day (n = 46) sultamicillin, or 500 mg/day (n = 51) or 1000 mg/day (n = 4) cefuroxime axetil for a minimum of 5 days. Variations in dose and duration of treatment were due to severity of symptoms. After treatment with sultamicillin for 8.1 +/- 1.5 days or with cefuroxime axetil for 7.9 +/- 1.6 days, local pain, erythema, exudate, oedema and adenopathies were improved in both treatment groups and all sultamicillin-treated patients were apyretic. All sultamicillin-treated and all but three cefuroxime axetil-treated patients experienced cure or improvement; only one cefuroxime axetil-treated patient discontinued treatment due to treatment failure. Gastrointestinal adverse events occurred in both treatment groups (eight sultamicillin-treated patients and three cefuroxime axetil-treated patients); one patient receiving cefuroxime axetil discontinued treatment due to nausea. Pruritus was reported by one sultamicillin-treated patient.

Topics: Adult; Ampicillin; Bacterial Infections; Cefuroxime; Drug Therapy, Combination; Humans; Otitis Media; Pharyngitis; Respiratory Tract Diseases; Rhinitis; Sinusitis; Sulbactam; Tonsillitis

In this randomized, blinded, multicenter comparison study, 377 infants and children with acute otitis media (AOM) received a 10-day course of an oral suspension of one of the following: cefuroxime axetil (CAE), 30 mg/kg/day; cefaclor (CEC), 40 mg/kg/day; or amoxicillin-clavulanate potassium (AMX-CL), 40 mg/kg/day. Clinical efficacy was determined by pneumatic otoscopy and tympanometric testing 3 to 5, 11 to 14, and 22 to 26 days after the initiation of therapy. There was a statistically significant difference among the three treatment groups with respect to clinical outcome; more patients in the CAE group (62%) than in the CEC group (46%) or the AMX-CL group (52%) had complete resolution of signs and symptoms of AOM (including effusion). Paired comparisons revealed a significant difference in efficacy between CAE and CEC and a nearly significant difference between AMX-CL and CEC. Taste acceptability was highest for CEC and lowest for this formulation of CAE. Significantly more patients in the AMX-CL group than in the CAE or CEC group had a side effect, primarily diarrhea, vomiting, or diaper rash. We conclude that CAE suspension has greater clinical efficacy than CEC and fewer side effects than AMX-CL.

Topics: Acoustic Impedance Tests; Acute Disease; Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Analysis of Variance; Cefaclor; Cefuroxime; Child; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Evaluation Studies as Topic; Female; Humans; Infant; Male; Otitis Media; Time Factors

To evaluate, by applying pharmacokinetic/pharmacodynamic (PK/PD) analysis, if the change in antibiotic susceptibility after the introduction of the 7-valent pneumococcal conjugate vaccine (PCV7) in Spain had any influence on the usefulness of the antimicrobials more frequently used as empirical treatment of pediatric acute otitis media (AOM).. PK parameters and susceptibility of Streptococcus pneumoniae and Haemophilus influenzae were obtained from bibliography. Monte Carlo simulation was used to estimate the cumulative fraction of response (CFR), understood as the expected probability of therapy success. For amoxicillin and amoxicillin/clavulanate, the target was free antibiotic concentration remaining above the minimum inhibitory concentration (MIC) for ≥50% of the dosing interval (fT>MIC≥50%), whereas for cefuroxime axetil and cefotaxime, the target was fT>MIC≥60%. CFR values ≥90% were considered successful.. When all serotypes of S. pneumoniae are considered, amoxicillin and cefotaxime turned out to reach a high probability of success, and difference before and after vaccination was scarce. For H. influenzae, CFR values were higher with amoxicillin/clavulanate than with amoxicillin. For both microorganisms, cefuroxime axetil resulted in low probability of success in the two periods of study.. We have shown that the introduction of the PCV7 vaccination did not lead to changes in the probability of success of the current empiric treatments of the AOM. Integrated PK/PD analysis has demonstrated to be a useful tool to identify changes in antimicrobial activity after the implantation of a vaccination program, providing complementary information to the simple assessment of MIC values.

Topics: Algorithms; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefuroxime; Child; Female; Haemophilus influenzae; Heptavalent Pneumococcal Conjugate Vaccine; Humans; Male; Microbial Sensitivity Tests; Monte Carlo Method; Otitis Media; Spain; Streptococcal Vaccines; Streptococcus pneumoniae; Treatment Outcome; Vaccination

To know the variability of treatment of acute otitis media in Spain and the appropriateness of such with respect to consensus.. A descriptive, multicentre, prospective study was carried out in the services of 11 Spanish hospitals. Children diagnosed with acute otitis media and treated on 30 days selected randomly between January and June 1997 were included. An analysis of treatment variability was made. The results were compared with consensus conference of a panel of experts.. Out of the 29436 emergencies studied on 30 days, 821 were diagnosed with acute otitis media. Fifteen point seven percent of the cases were already receiving antibiotics (22% amoxicillin clavulanate, 20% amoxicillin and 11% cefuroxime axetil). For the treatment, at discharge, of the 93% an antibiotic was prescribed (amoxicillin clavulanate in 41%, amoxicillin in 15%, cefuroxime axetil in 11%, cefaclor 6% and azithromycin 5%). Two point eight percent of the children were admitted. According to the guidelines of the panel of experts consulted, appropriateness was 61% for antibiotics of first choice, 12% for drugs of alternate use and 25% for inadequate treatment. The different hospitals presented significant variability in the type of antibiotic used and the appropriateness of such.. Acute otitis media is treated with antibiotics in 93% of the cases diagnosed in Spanish hospitals. The most commonly used antibiotics are amoxicillin clavulanate and amoxicillin alone. The prescription and its appropriateness present significant variability in the different hospitals studied.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefuroxime; Cephalosporins; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Penicillins; Practice Guidelines as Topic; Prospective Studies

The aim of this work was the assessment of therapeutic efficacy of antibiotic Zinnat (Cefuroksym Aksetyl) in ambulatory treatment of acute pharyngitis and otitis media in 20 adult patients, aged 21-36. The efficacy of Zinnat was assessed on the basis of the smear from the throat and external auditory meatus to examine the culture and antibiogram, fever chart and self-assessment chart of symptoms which were assessed from 0 to 4. It was shown that Zinnat is an effective antibiotic in ambulatory treatment of acute pharyngitis and otitis media. It shows a wide range of antibacterial effect comprising most often occurring pathogens bringing about acute pharyngitis and otitis media.

Topics: Acute Disease; Adult; Ambulatory Care; Cefuroxime; Cephalosporins; Female; Humans; Male; Otitis Media; Pharyngitis

Eighty-four children suffering from acute otitis media caused by Streptococcus pneumoniae were treated prospectively with cefuroxime axetil suspension (30 mg/kg of body weight twice daily for 8 days). The high incidence of isolates with decreased susceptibilities to penicillin (42 of 84 isolates) allowed us to establish a relationship between clinical success and the penicillin MICs for pneumococcal isolates. It was found that cefuroxime axetil is clinically effective in the treatment of acute otitis media caused by penicillin-susceptible and penicillin-intermediate strains of S. pneumoniae. The results indicate that the risk of treatment failure with cefuroxime axetil was increased in children with otitis media caused by S. pneumoniae when the penicillin MIC were greater than or equal to 2 mg/liter.

Topics: Acute Disease; Cefuroxime; Child, Preschool; Humans; Infant; Microbial Sensitivity Tests; Otitis Media; Penicillin Resistance; Pneumococcal Infections; Prodrugs; Prospective Studies; Streptococcus pneumoniae

We have used a dynamic in-vitro model to determine the killing kinetics of two formulations of cefuroxime axetil against 18 clinical strains of Haemophilus influenzae. The concentration of cefuroxime axetil was adjusted dynamically to simulate the mean serum profile in healthy volunteers following the administration of a single 250 mg dose in oral suspension or tablet form. Bacterial numbers were reduced by 3 log10 cfu/mL during the eight-hour experimental period with both dosage form simulations. Our results suggest that cefuroxime axetil, 250 mg in oral suspension or tablet form, may protect against the dissemination of H. influenzae during episodes of bacteraemia.

Topics: Administration, Oral; Adult; Capsules; Cefuroxime; Child; Haemophilus influenzae; Humans; Kinetics; Models, Biological; Otitis Media; Tablets

Antimicrobial agents play an important role in the treatment of patients with acute otitis media and otitis media with effusion (OME). The study was undertaken to determine the concentrations of cefuroxime in the blood and middle ear effusions (MEE) of children between 6 and 12 years of age with acute otitis media and chronic OME after a single oral dose administration of cefuroxime axetil, the ester prodrug of cefuroxime. Cefuroxime axetil (250 mg) was administered 2 to 6 hours before either myringotomy for acute otitis media or myringotomy and tube insertion for chronic OME. Blood samples and middle ear aspirates were obtained from 31 children and the samples were analyzed by high performance liquid chromatography. Cefuroxime was recovered in measurable concentrations in all serum samples and in 15 (79%) of the 19 MEE specimens analyzed. No correlation was seen between cefuroxime MEE concentrations and effusion type, bacteriology or serum concentrations. This study shows that cefuroxime does penetrate into MEE when OME is present and that therapeutic concentrations can be achieved in some patients.

Topics: Acute Disease; Administration, Oral; Cefuroxime; Child; Chronic Disease; Exudates and Transudates; Female; Humans; Male; Otitis Media; Otitis Media with Effusion; Prodrugs