amoxicillin-potassium-clavulanate-combination and Otitis-Media

Acute otitis media (AOM) is the inflammation of the middle ear. It constitutes one of the most frequent infections which affects children and usually occurs between 6 to 24 months of age. AOM can emerge due to viruses and/or bacteria. The aim of the current systematic review is to assess in children between 6 months and 12 years of age with AOM, the efficacy of any antimicrobial agent or placebo compared with amoxicillinclavulanate, to measure the resolution of AOM or symptoms.. The medical databases PubMed (MEDLINE) and Web of Science were used. Data extraction and analysis were performed by two independent reviewers. Eligibility criteria were set, and only randomised control trials (RCTs) were included. Critical appraisal of the eligible studies was performed. Pooled analysis was conducted using the Review Manager v. 5.4.1 software (RevMan).. Twelve RCTs were totally included. Three (25.0%) RCTs studied the impact of azithromycin, two (16.7%) investigated the impact of cefdinir, two (16.7%) investigated placebo, three (25.0%) studied quinolones, one (8.3%) investigated cefaclor and one (8.3%) studied penicillin V, compared to amoxicillin-clavulanate. In five (41.7%) RCTs, amoxicillin-clavulanate proved to be superior to azithromycin, cefdinir, placebo, cefaclor and penicillin V, while in seven (58.3%) RCTs its efficacy was comparable with other antimicrobials or placebo. The rates of AOM relapse after treatment with amoxicillin-clavulanate were comparable to those of other antimicrobials or placebo. However, amoxicillin-clavulanate was more effective in eradicating Streptococcus pneumoniae from the culture, when compared to cefdinir. The results of the meta-analysis were not evaluated due to substantial heterogeneity between studies.. Amoxicillin-clavulanate should be the treatment of choice for children between 6 months and 12 years of age with AOM.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Azithromycin; Cefaclor; Cefdinir; Child; Humans; Infant; Otitis Media; Penicillin V; Treatment Outcome

Resistance, prolonged therapy, and more adverse reactions made amoxicillin less preferred for treating otitis media. This study aimed to compare the efficacy and safety of azithromycin and amoxicillin/clavulanate for the treatment of otitis media in children.. This study was a systematic review and meta-analysis. PubMed, Cochrane library, and Google scholar databases were searched. Comparative randomized clinical trial studies between azithromycin and amoxicillin/clavulanate to treat otitis media in children published up to 30 September 2019 were included. The risk of bias was assessed and Data was extracted by the first author and checked by the second author. Meta-analysis was performed by STATA software version 16, and Mantel-Haenszel statistical method with effect measure odds ratio was employed for analysis.. 751 records were identified and 14 studies were eligible for analysis. In 12 studies azithromycin had equivalent clinical efficacy and 2 had less to amoxicillin/clavulanate. Meta-analysis results showed no statistically significant difference in efficacy in favor of amoxicillin/clavulanate after completion of treatment OR 0.75, 95% CI (0.62-0.91). On subgroup analysis for children less than 2 years (OR 0.96 95% CI (0.49-2.29), and greater than 2 years (OR 1.40 95% CI (0.93-2.11) and also efficacy on follow up (OR 0.97 95% CI (0.83-1.15) there is no statistically significant difference. The clinical adverse events are more in the amoxicillin/clavulanate group than in the azithromycin with a statistical significant difference OR 0.46 95% CI (0.43-0.56).. Azithromycin is comparable to amoxicillin/clavulanate to treat otitis media in children, and it is safer and more tolerable.

Topics: Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Biomarkers, Pharmacological; Child; Child, Preschool; Drug Administration Schedule; Drug Monitoring; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Randomized Controlled Trials as Topic; Treatment Outcome

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

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Ceftriaxone; Child; Drug Administration Schedule; Humans; Otitis Media; Randomized Controlled Trials as Topic; Treatment Failure

Macrolide antibiotics are often used to treat children with acute otitis media (AOM); however, the 2004 American Academy of Pediatrics (AAP) and American Academy of Family Physicians guidelines recommend against their use in patients without history of a type I allergic reaction to penicillins.. To evaluate via meta-analysis the comparative efficacy of amoxicillin or amoxicillin/clavulanate to that of macrolide antibiotics in the treatment of children with AOM.. A systematic literature search of MEDLINE, EMBASE, and International Pharmaceutical Abstracts was conducted from the earliest available date through September 2008. We used the following MeSH and key words: amoxicillin, amoxicillin/clavulanate, Augmentin, azithromycin, ceftriaxone, clarithromycin, macrolides, AND media, otitis media, and effusion. Included studies were randomized, blinded, and controlled trials evaluating guideline-recommended antibiotics (amoxicillin or amoxicillin/clavulanate) compared to macrolide antibiotics (azithromycin or clarithromycin) in AOM in children. The primary outcome assessed was clinical failure measured between days 10 and 16 after starting antibiotic therapy. Results are reported as relative risks (RRs) with 95% confidence intervals and were calculated using a random-effects model.. A total of 10 trials (N = 2766) evaluating children 6 months-15 years old were included in the meta-analysis. Upon meta-analysis, the use of macrolide antibiotics was associated with an increased risk of clinical failure (RR 1.31 [95% CI 1.07 to 1.60]; p = 0.008) corresponding to a number needed to harm of 32. Upon safety analysis, rates of any adverse reaction (RR 0.74 [95% CI 0.60 to 0.90]; p = 0.003) and diarrhea (RR 0.41 [95% CI 0.32 to 0.52]; p < 0.0001) were significantly lower in the macrolide group.. The meta-analysis suggests that patients treated with macrolides for AOM may be more likely to have clinical failures. As such, it supports the current AAP AOM recommendation that macrolides be reserved for patients who can not receive amoxicillin or amoxicillin/clavulanate.

Topics: Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Humans; Infant; Macrolides; Otitis Media; Practice Guidelines as Topic; Randomized Controlled Trials as Topic; Treatment Failure

Children attending day care centers (DCCs) frequently carry antibacterial-resistant organisms in their nasopharynx, leading to acute otitis media (AOM) that may be refractory to antibacterial treatment. The development and spread of resistant organisms are facilitated in DCCs as a result of the following: (i) large numbers of children; (ii) frequent close person-to-person contact; and (iii) a wide use of antimicrobial medications. Intensive antimicrobial usage provides the selection pressure that favors the emergence of resistant organisms, while DCCs provide an ideal environment for transmission of these organisms. The American Academy of Pediatrics and American Academy of Family Physicians' guidelines recommend high-dose amoxicillin/clavulanic acid (rather than amoxicillin alone) as the first therapeutic choice in the treatment of AOM in children attending DCCs. The introduction of the 7-valent pneumococcal conjugated vaccine (PCV7) had a major role in decreasing the number of episodes of Streptococccus pneumoniae AOM secondary to the serotypes included in the vaccine. It also had a major role in reducing the nasopharyngeal carriage of vaccine-type S. pneumoniae (and in particular of antibacterial-resistant organisms), preventing, in this way, its spread to contacts in the community. However, the recent observation of increased rates of antibacterial-resistant non-vaccine serotype S. pneumoniae may erode the success of PCV7.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child Day Care Centers; Child, Preschool; Drug Resistance, Bacterial; Heptavalent Pneumococcal Conjugate Vaccine; Humans; Infant; Infant, Newborn; Meningococcal Vaccines; Otitis Media; Pharynx; Pneumococcal Infections; Pneumococcal Vaccines; Practice Guidelines as Topic; Streptococcus pneumoniae

Double tympanocentesis studies of children with acute otitis media, carried out over an 11-year period, were used to confirm that pharmacokinetic (PK) and pharmacodynamic (PD) parameters can be used as predictors of the bacteriological and clinical efficacy of antimicrobial agents. Predicted susceptibilities of common respiratory pathogens, such as Streptococcus pneumoniae and Haemophilus influenzae, were compared with the bacteriological outcome of treatment in which the high-dose formulation of amoxicillin/clavulanate (90mg/kg/day) given twice daily achieved the greatest bacteriological eradication rates for an oral agent. Further analysis of the data has indicated that failure to eradicate bacteria from the middle ear fluid is strongly correlated with clinical failure.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Haemophilus Infections; Haemophilus influenzae; Humans; Microbial Sensitivity Tests; Otitis Media; Pneumococcal Infections; Streptococcus pneumoniae; Treatment Outcome

To determine whether guidelines relating to the diagnosis and treatment of acute otitis media (AOM) in children are followed in a tertiary paediatric emergency department (ED).. A literature search was undertaken to identify national and international guidelines relating to the diagnosis and management of AOM in children. The guidelines were assessed for their applicability to UK practice. A retrospective case note audit was undertaken. Children presenting to the ED with a discharge diagnosis of AOM over a two month period were identified from the ED computer discharge system. The notes were analysed for compliance with the identified guidelines.. 50 children were identified (age range three months to 11 years). Eighty-six per cent of children received antibiotics. Fifty-two per cent of children had documented signs of AOM. Twenty-five of these children received antibiotics (22 in accordance with guidelines, three not in accordance with guidelines, antibiotic not documented in one case). Thirty-nine per cent of children received antibiotics inappropriately. In all cases, the antibiotic dosage was below the dose recommended in all guidelines.. There is poor compliance with national (and international) guidelines for the management of AOM in this ED. National guidelines must be introduced into the department by direct teaching at senior house officer and middle grade level, a re-audit must be carried out and regular reviews of the notes of patients diagnosed with AOM must be undertaken to ensure compliance with guidelines is maintained.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Emergency Medical Services; Guideline Adherence; Humans; Infant; Medical Audit; Otitis Media; Practice Guidelines as Topic; Retrospective Studies; Risk Factors; United Kingdom

Amoxicillin/clavulanic acid (Augmentin), Augmentin ES-600 is a well established, orally administered combination of amoxicillin (a semisynthetic antibacterial agent) and clavulanic acid (a beta-lactamase inhibitor). Amoxicillin/clavulanic acid shows good activity against the main pathogens associated with acute otitis media (AOM), including penicillin-susceptible and -intermediate strains of Streptococcus pneumoniae, and beta-lactamase producing strains of Haemophilus influenzae and Moraxella catarrhalis. It has moderate activity against penicillin-resistant S. pneumoniae; a high-dose formulation has been developed with the aim of providing better coverage for penicillin-resistant strains. Amoxicillin/clavulanic acid (conventional formulations, mostly 40/10 mg/kg/day in three divided doses) produced clinical response rates similar to those of oral cephalosporin comparators and similar to or significantly greater than those for intramuscular ceftriaxone in randomised trials in paediatric patients with AOM (mean age approximately 2 to 5 years). Clinical response rates were generally similar for amoxicillin/clavulanic acid and macrolide comparators (mean patient age approximately 1 to 6 years), although significantly better clinical and bacteriological responses were seen versus azithromycin in one randomised trial (mean patient age approximately 1 year). The high-dose formulation of amoxicillin/clavulanic acid (90/6.4 mg/kg/day in two divided doses) eradicated a high proportion of penicillin-resistant S. pneumoniae (penicillin MICs 2 or 4 mg/L) in a large noncomparative trial in children with AOM (upper limit of the US indication for S. pneumoniae is 2 mg/L). Amoxicillin/clavulanic acid is generally well tolerated. A low total incidence of adverse events (3.6%) and no serious events were reported from a large paediatric postmarketing study. The most frequently reported adverse events in children are mild gastrointestinal disturbances. Diarrhoea is generally less frequent with twice-daily than with three-times-daily treatment. The new high-dose formulation showed similar tolerability to a conventional twice-daily formulation (45/6.4 mg/kg/day) in a well controlled trial.. Amoxicillin/clavulanic acid is a well established broad-spectrum antibacterial treatment which is effective and well tolerated in the treatment of AOM in paediatric patients. The high-dose combination should prove valuable in treating AOM caused by penicillin-intermediate and -resistant S. pneumoniae (approved in the US for penicillin MIC < or =2 mg/L). Based on recent recommendations and the available data, high-dose amoxicillin/clavulanic acid can be considered a treatment of choice for recurrent or persistent paediatric AOM (after failure of amoxicillin alone) where involvement of resistant pathogens is suspected.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Child; Clinical Trials as Topic; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Resistance, Bacterial; Drug Therapy, Combination; Humans; Microbial Sensitivity Tests; Otitis Media

Evidence from studies in otitis media indicates that antimicrobials and dosing regimens that have equivalent bacteriologic efficacy against susceptible pathogens can have significantly different bacteriologic success rates against resistant strains of the same species. Unlike macrolide and fluoroquinolone resistance, penicillin resistance can be overcome in Streptococcus pneumoniae by increasing the dose, and hence increasing the time for which the serum concentrations are above the MIC. The new clinical formulation of extra-strength amoxicillin-clavulanate provides 90 mg/kg per day amoxicillin plus 6.4 mg/kg per day clavulanate (14:1) divided every 12 h, compared with 45/6.4 mg/kg per day b.i.d. with conventional dosing. The pharmacokinetic/pharmacodynamic (PK/PD) profiles of extra-strength amoxicillin-clavulanate predict that the new formulation will be more effective than the conventional formulation against S. pneumoniae with elevated amoxicillin MICs and against Haemophilus influenzae. In an open-label, non-comparative study in children with acute otitis media, the extra-strength formulation had high bacteriologic success rates against the major respiratory pathogens, including penicillin-resistant S. pneumoniae. The development of new antimicrobial agents and formulations should be aimed at meeting PK/PD parameters predictive of bacterial eradication of both susceptible and resistant strains.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Area Under Curve; Child; Haemophilus Infections; Haemophilus influenzae; Humans; Microbial Sensitivity Tests; Otitis Media; Pneumococcal Infections; Streptococcus pneumoniae; Treatment Failure

Chemical synthesis of the penicillin nucleus in the 1950s made introduction of a broad array of new and important antimicrobials, including ampicillin and amoxicillin, possible. Ampicillin was introduced in 1962 in oral and parenteral forms as the first of the semisynthetic penicillins to provide increased activity against Gram-negative bacteria. Amoxicillin replaced oral ampicillin beginning in 1974 because amoxicillin resulted in higher and more prolonged serum concentrations than did equivalent doses of ampicillin. Amoxicillin/clavulanate (Augmentin) was introduced in the United States in 1984 to enhance the activity of amoxicillin by addition of the beta-lactamase inhibitor, clavulanic acid. During the past 20 years, amoxicillin/clavulanate has proven effective for a variety of pediatric infectious diseases, particularly acute otitis media (AOM). In 2001, a new pediatric formulation, high dose amoxicillin/clavulanate (Augmentin ES-600) was approved for use in the United States. The high dose preparation addressed the needs of pediatricians by providing greater amounts of amoxicillin while maintaining the same daily dose of clavulanic acid as the regular strength formulation. Doubling the dose of amoxicillin for management of recurrent and persistent AOM was recommended in 1999 by the Centers for Disease Control and Prevention because of concern about the increased incidence of nonsusceptible strains of Streptococcus pneumoniae. The original formulation combined amoxicillin/clavulanate in a 4:1 ratio and was followed by a 7:1 ratio formulation. The high dose formulation (600 mg of amoxicillin per 5 ml) provides a 14:1 ratio of amoxicillin to clavulanate. Although management of AOM will likely undergo changes in the coming years, amoxicillin is expected to remain first line therapy for AOM. For children who fail initial therapy with amoxicillin, high dose amoxicillin/clavulanate, an oral cephalosporin or parenteral ceftriaxone is recommended.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Drug Resistance, Bacterial; Drug Therapy, Combination; Haemophilus influenzae; Humans; Infant; Moraxella catarrhalis; Otitis Media; Streptococcus pneumoniae

The major problems encountered in the antibiotic therapy of acute otitis media (AOM) are the tremendous increase in the resistance to antibiotics of its main pathogens and the lack of tight criteria (taking into consideration, as a major determinant, the eradication of the pathogens from the middle ear fluid) in the selection of the appropriate antibiotic drugs for the treatment of this disease. Future drugs for the treatment of AOM will have to be approved only after their in vivo microbiological efficacy for each major pathogen is documented. This documentation will be provided by more antibiotic studies with bacteriological outcome using the double-tympanocentesis method and stratifying the AOM patients by age and initial clinical severity. Judicious use of antibiotics for the treatment of AOM will have a major impact on society, leading to a less frequent but more skilled administration of the most effective drugs.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Cephalosporins; Drug Resistance, Microbial; Humans; Macrolides; Otitis Media; Trimethoprim, Sulfamethoxazole Drug Combination

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

Cefprozil was evaluated in the treatment of acute otitis media with effusion in three open, randomized, multicenter comparative clinical trials. In two trials, 891 pediatric patients were enrolled to either cefprozil or amoxicillin-clavulanate dosage regimens. The treatment groups were comparable in demographic characteristics, and presented with otalgia, middle-ear effusion, or inflamed or bulging tympanic membrane on otoscopic examination. In all patients, tympanocentesis and a culture were required. Two cefprozil oral doses were evaluated, 30 mg/kg/day and 40 mg/kg/day divided into two equal doses (b.i.d.). Amoxicillin-clavulanate was administered at 40 mg/kg/day in three divided doses (t.i.d.). The recommended duration of therapy was ten days. The predominant bacteria isolated were Haemophilus influenzae and Moraxella catarrhalis. The overall satisfactory clinical response rates were similar for cefprozil (83%) and amoxicillin-clavulanate (81%). The bacteriological response rates did not differ significantly, at 84% and 82%. Cefprozil eradicated the most common pathogen, Streptococcus pneumoniae, more often at 91%, vs. 84% for amoxicillin-clavulanate. The eradication rates were similar against Haemophilus influenzae and Moraxella catarrhalis. The patients treated with cefprozil had a lower rate of adverse clinical events (11%) compared to those with amoxicillin-clavulanate (20%). More gastrointestinal adverse experiences, including diarrhea, were reported in the amoxicillin-clavulanate-treated patients. In Study 3, cefprozil 30 mg/kg/day (b.i.d.) was compared to cefaclor 40 mg/kg/day (t.i.d.) and cefixime 8 mg/kg/day (q.d) in the treatment of acute otitis media in 388 pediatric patients. The patients were treated for 10 days, with a follow-up of 18 days. The overall clinical cure rates were 85%, 89% and 85%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cefaclor; Cefixime; Cefotaxime; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Multicenter Studies as Topic; Otitis Media; Randomized Controlled Trials as Topic

The choice of antibiotics to be prescribed in otitis media may be guided by microbiological culture of the middle ear exudate obtained by tympanocentesis, or by direct examination and culture of purulent material obtained by myringotomy after rupture of the tympanic membrane. Otherwise, routine antibiotic prescription is based on the epidemiological frequencies of bacteria such as Streptococcus pneumoniae, Hoemophilus influenza or Strepcococcus A. In children who have infrequently received beta-lactam antibiotics, amoxicillin 50-75 mg/kg/day for 10 days may be the first choice. Children who suffer from recurrent episodes of acute otitis media may benefit from one of the three following prescriptions: amoxicillin + clavulanate (Augmentin), or an oral cephalosporin, or the erythromycin + sulfisoxazole combination (Pediazole). If recurrences are frequent and at short intervals, antibiotic prophylaxis may be effective, using penicillin V (Oracillin) 250,000 IU daily throughout the entire cold period.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Clavulanic Acids; Humans; Hypoglycemic Agents; Otitis Media; Recurrence

Young children with acute otitis media (AOM) frequently exhibit nasopharyngeal colonization with either Streptococcus pneumoniae, Haemophilus influenzae or both pathogens. We aimed to determine if antibiotics could be spared or shortened in those without nasopharyngeal colonization with either pathogen.. In 2 separate randomized clinical trials in children aged 6-23 months with stringently-diagnosed AOM, we performed bacterial cultures on nasopharyngeal specimens collected at the time of diagnosis. In the first trial, we compared the efficacy of amoxicillin/clavulanate (amox/clav) administered for 10 days vs. that of placebo, and in the second trial, we compared the efficacy of amox/clav administered for 10 days vs. 5 days. In each trial, we classified children as being colonized with both S. pneumoniae and H. influenzae, S. pneumoniae alone, H. influenzae alone, or neither pathogen, and as experiencing either clinical success or clinical failure at the end-of-therapy visit, based on previously reported a priori criteria.. We evaluated 796 children. Among children randomized to amox/clav, those colonized with either S. pneumoniae or H. influenzae or both were approximately twice as likely to experience clinical failure as children not colonized with either pathogen (odds ratio: 1.8; confidence intervals: 1.2-2.9). In contrast, among children randomized to placebo, clinical failure at the end-of-therapy visit was not associated with nasopharyngeal culture results at the time of diagnosis.. Children colonized with either S. pneumoniae or H. influenzae or both have a greater chance of treatment failure than children colonized with neither pathogen.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Haemophilus influenzae; Humans; Infant; Nasopharynx; Otitis Media; Streptococcus pneumoniae; Treatment Failure

Acute otitis media (AOM) is the most frequent reason for children to be prescribed antimicrobial treatment. Surfactants are naturally occurring substances that may restore the eustachian tube's function and potentially enhance resolution of AOM.. This was a phase 2a, single-center, double-blind, randomized, placebo-controlled, parallel group clinical trial to assess safety, tolerability, and efficacy of 20 mg per day intranasal OP0201 as an adjunct therapy to oral antimicrobial agents for treating AOM in young children. We randomly assigned 103 children aged 6 to 24 months with AOM to receive either OP0201 or placebo twice daily for 10 days. All children received amoxicillin-clavulanate 90/6.4 mg/kg per day in 2 divided doses for 10 days. Participants were managed for up to 1 month. Postrandomization visits occurred between days 4 and 6 (visit 2), days 12 and 14 (visit 3), and days 26 and 30 (visit 4). Primary efficacy endpoints were resolution of a bulging tympanic membrane at visit 2 and resolution of middle-ear effusion at visit 3.. No clinically meaningful differences between treatment groups were apparent for primary or secondary endpoints. There were no safety concerns identified.. In young children with AOM, intranasally administered surfactant (OP0201) did not improve clinical outcomes. Further research may be warranted among children with persistent middle-ear effusion.

Topics: Acute Disease; Administration, Intranasal; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Otitis Media with Effusion; Surface-Active Agents

To compare postoperative infection and graft uptake rate using single dose of intravenous co-amoxiclav versus no antibiotic in children undergoing myringoplasty.. This is a prospective, randomized controlled study conducted in children of age 6-15 years with chronic otitis media (COM) mucosal, inactive type undergoing myringoplasty. Postoperative infection over a period of 4 weeks and status of graft at or around 3 months after surgery was studied as outcome measure.. Fifty five out of sixty children completed follow-up. The overall postoperative infection rate was 5.4%. Postoperative infection rate was 3.5% in children receiving prophylactic antibiotic and 7.4% in children receiving no antibiotic. There was no statistically significant difference in postoperative infection between two groups (P > 0.05). The overall graft uptake rate was 87.27%. It was 85.7% in antibiotic used group and 88.8% in non-antibiotic group with no statistically significant difference (P > 0.05).. Postoperative infection following myringoplasty in children is uncommon as it is a clean type of surgery. There was no statistically significant difference in postoperative infection and graft uptake rate by the use of prophylactic antibiotic in the intraoperative period. This study shows no benefit of a prophylactic antibiotic on postoperative infection or graft success in myringoplasty in children.. NCT03700814.

Topics: Administration, Intravenous; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Chronic Disease; Female; Follow-Up Studies; Humans; Male; Myringoplasty; Otitis Media; Postoperative Complications; Prospective Studies; Treatment Outcome; Tympanic Membrane Perforation

Amoxicillin-clavulanate (A/C) is currently the most effective oral antimicrobial in treating children with acute otitis media (AOM), but the standard dosage of 90 mg amoxicillin/6.4 mg clavulanate/kg of body weight/day commonly causes diarrhea. We examined whether an A/C formulation containing lower concentrations of clavulanate would result in less diarrhea while maintaining plasma levels of amoxicillin and clavulanate adequate to eradicate middle-ear pathogens and to achieve clinical success. We conducted an open-label study in children with AOM who were 6 to 23 months of age. In phase 1, we treated 40 children with a reduced-clavulanate A/C formulation providing 90 mg amoxicillin/3.2 mg clavulanate/kg/day for 10 days. In phase 2, we treated 72 children with the same formulation at a dosage of 80 mg amoxicillin/2.85 mg clavulanate/kg/day for 10 days. We compared the rates of protocol-defined diarrhea (PDD), diaper dermatitis, and AOM clinical response in these children with rates we had reported in children who received the standard A/C regimen, and we obtained plasma levels of amoxicillin and clavulanate at various time points. Outcomes in phase 1 children and in children who had received the standard regimen did not differ significantly. Rates of PDD in children receiving phase 2 and standard regimens were 17% and 26%, respectively (

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Clavulanic Acid; Dermatitis; Diarrhea; Female; Humans; Infant; Infant, Newborn; Male; Otitis Media

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Drug Administration Schedule; Drug Resistance, Bacterial; Female; Humans; Infant; Male; Otitis Media; United States

Antimicrobial treatment is effective in the management of acute otitis media (AOM), but approximately half of the children may recover without antimicrobial agents. By identifying patients who may not require antimicrobial treatment for the management of AOM, the use of antimicrobial agents could be substantially reduced. Our aim was to identify subgroups of children with AOM who would benefit most from antimicrobial treatment and children who could be suitable for initial observation.. Treatment failure occurred in 31.7% of all children. Older age (24-35 months) and peaked tympanogram at entry decreased the hazard for treatment failure (hazard ratio, 0.53; 95% confidence interval [CI], 0.29 to 0.96;. Children with severe bulging of the tympanic membrane seem to benefit most from antimicrobial treatment of AOM. On the other hand, children with peaked tympanogram (A and C curves) may be optimal candidates for initial observation.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Child, Preschool; Double-Blind Method; Female; Humans; Infant; Male; Otitis Media; Prognosis; Treatment Failure; Tympanic Membrane

Limiting the duration of antimicrobial treatment constitutes a potential strategy to reduce the risk of antimicrobial resistance among children with acute otitis media.. We assigned 520 children, 6 to 23 months of age, with acute otitis media to receive amoxicillin-clavulanate either for a standard duration of 10 days or for a reduced duration of 5 days followed by placebo for 5 days. We measured rates of clinical response (in a systematic fashion, on the basis of signs and symptomatic response), recurrence, and nasopharyngeal colonization, and we analyzed episode outcomes using a noninferiority approach. Symptom scores ranged from 0 to 14, with higher numbers indicating more severe symptoms.. Children who were treated with amoxicillin-clavulanate for 5 days were more likely than those who were treated for 10 days to have clinical failure (77 of 229 children [34%] vs. 39 of 238 [16%]; difference, 17 percentage points [based on unrounded data]; 95% confidence interval, 9 to 25). The mean symptom scores over the period from day 6 to day 14 were 1.61 in the 5-day group and 1.34 in the 10-day group (P=0.07); the mean scores at the day-12-to-14 assessment were 1.89 versus 1.20 (P=0.001). The percentage of children whose symptom scores decreased more than 50% (indicating less severe symptoms) from baseline to the end of treatment was lower in the 5-day group than in the 10-day group (181 of 227 children [80%] vs. 211 of 233 [91%], P=0.003). We found no significant between-group differences in rates of recurrence, adverse events, or nasopharyngeal colonization with penicillin-nonsusceptible pathogens. Clinical-failure rates were greater among children who had been exposed to three or more children for 10 or more hours per week than among those with less exposure (P=0.02) and were also greater among children with infection in both ears than among those with infection in one ear (P<0.001).. Among children 6 to 23 months of age with acute otitis media, reduced-duration antimicrobial treatment resulted in less favorable outcomes than standard-duration treatment; in addition, neither the rate of adverse events nor the rate of emergence of antimicrobial resistance was lower with the shorter regimen. (Funded by the National Institute of Allergy and Infectious Diseases and the National Center for Research Resources; ClinicalTrials.gov number, NCT01511107 .).

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Drug Administration Schedule; Drug Resistance, Bacterial; Female; Haemophilus influenzae; Humans; Infant; Male; Nasopharynx; Otitis Media; Prognosis; Streptococcus pneumoniae; Treatment Failure

The objective of the present study was to determine whether changes in the previously developed 7-item Acute Otitis Media Severity of Symptoms scale could improve its responsiveness and its longitudinal construct validity. The items "diminished activity" and "diminished appetite" had low or borderline levels of responsiveness and longitudinal construct validity. Dropping these items seems to be potentially advantageous.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Humans; Infant; Otitis Media; Severity of Illness Index

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child, Preschool; Humans; Infant; Otitis Media; Placebos; Research Design; Treatment Outcome

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Finland; Humans; Infant; Otitis Media; Pennsylvania; Treatment Failure; Treatment Outcome

Watchful waiting with the option of delayed antimicrobial treatment for acute otitis media is recommended in several guidelines. Our aim was to study whether delayed, as compared with immediate, initiation of antimicrobial treatment worsens the recovery from acute otitis media in young children.. Children (6-35 months) with acute otitis media received either delayed or immediate antimicrobial treatment with amoxicillin-clavulanate for 7 days. The delayed antimicrobial treatment group (n = 53) consisted of placebo recipients from a randomized-controlled trial to whom antimicrobial treatment was initiated after a watchful waiting period. The immediate antimicrobial treatment group (n = 161) consisted of children allocated to receive antimicrobial treatment immediately.. Improvement during antimicrobial treatment (which includes both symptoms and otoscopic signs) was observed in 91% and 96% of children in the delayed and immediate antimicrobial treatment groups, respectively (P = 0.15). Median watchful waiting period was 48 hours. Delayed initiation of antimicrobial treatment was associated with prolonged resolution of fever, ear pain, poor appetite and decreased activity, but not ear rubbing, irritability, restless sleep or excessive crying. Parents of children in the delayed antimicrobial treatment group missed more work days (mean 2.1 versus 1.2 days, P = 0.03). Diarrhea, vomiting and rash were equally common in both groups.. Our results indicate that delayed initiation of antimicrobial treatment does not worsen the recovery from acute otitis media, as measured by improvement during treatment. However, watchful waiting before the initiation of delayed antimicrobial treatment might be associated with transient worsening of a child's condition, prolongation of symptoms and economic losses.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child, Preschool; Drug Therapy; Female; Humans; Infant; Male; Otitis Media; Prospective Studies; Time Factors; Treatment Outcome

10 days of amoxicillin/clavulanic acid high dose and 5 days of cefdinir have been the preferred first- or second-line antibiotics for treatment of children with acute otitis media (AOM) since 2004, as recommended by the American Academy of Pediatrics in the USA, but no head-to-head comparison study has been done.. The purpose of the study was to compare the clinical efficacy of amoxicillin/clavulanic acid high-dose therapy for 10 days with cefdinir therapy for 5 days for AOM at recommended doses.. This was an investigator-blind trial in young children 6-24 months old with no history of recurrent AOM who were randomly assigned to amoxicillin/clavulanic acid (80 mg/kg/day amoxicillin) or cefdinir (14 mg/kg/day), both in two divided doses. The diagnosis of AOM was based on specific clinical criteria by validated otoscopists at two AOM research centres. The outcome measure for clinical cure was resolution of all symptoms and signs of AOM except for persistence of middle-ear effusion at test-of-cure (TOC) 11-14 days after initiation of antibiotic treatment. Clinical failure was defined as persistence of symptoms and signs of AOM and the need for additional antibiotic therapy. Subjects lost to follow up or who had not taken at least 80% of the prescribed medication were classified as having an indeterminate response. Compliance was monitored using Medical Electronic Monitoring System (MEMS) caps and antibiotic bottle volume measurement at the TOC visit. A logistic regression model was used to estimate the association of age with cure rate. Full interactions in terms of age with treatment were included to estimate any age gradient differential.. A total of 330 children (average age 13.1 months) with AOM were studied. At TOC, 256 children had clinical cure, 69 had clinical failure, and 5 were lost to follow-up. High-dose amoxicillin/clavulanic acid-treated children had a better cure rate (86.5%) than cefdinir-treated patients (71.0%; p = 0.001). Cefdinir was correlated with less frequent cure outcomes as children increased in age between 6 and 24 months. The odds ratios for clinical cure per increasing month of age estimated from a logistic regression model for amoxicillin/clavulanic acid high dose and cefdinir treatment groups was 0.992 (95% CI 0.932, 1.056), p > 0.05 and 0.932 (95% CI 0.881, 0.986), p = 0.01. The differences in the odds ratios are significant at p < 0.002, indicating a stable clinical cure rate across the ages of children studied for amoxicillin/clavulanic acid and decreasing clinical cure rates as children increased in age for cefdinir.. In children with bona fide AOM for whom clinical outcomes are assessed by validated otoscopists, 10 days of high-dose amoxicillin/clavulanic acid is significantly more effective than 5 days of cefdinir as therapy for AOM. Because of the identified age effect (correlated to child weight), higher doses of cefdinir may have led to a different conclusion; 10 days of cefdinir may also have led to a different conclusion.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefdinir; Cephalosporins; Drug Administration Schedule; Follow-Up Studies; Humans; Infant; Otitis Media; Prospective Studies; Single-Blind Method; Treatment Outcome

Recommendations vary regarding immediate antimicrobial treatment versus watchful waiting for children younger than 2 years of age with acute otitis media.. We randomly assigned 291 children 6 to 23 months of age, with acute otitis media diagnosed with the use of stringent criteria, to receive amoxicillin-clavulanate or placebo for 10 days. We measured symptomatic response and rates of clinical failure.. Among the children who received amoxicillin-clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7; among children who received placebo, 28% had initial resolution of symptoms by day 2, 54% by day 4, and 74% by day 7 (P=0.14 for the overall comparison). For sustained resolution of symptoms, the corresponding values were 20%, 41%, and 67% with amoxicillin-clavulanate, as compared with 14%, 36%, and 53% with placebo (P=0.04 for the overall comparison). Mean symptom scores over the first 7 days were lower for the children treated with amoxicillin-clavulanate than for those who received placebo (P=0.02). The rate of clinical failure--defined as the persistence of signs of acute infection on otoscopic examination--was also lower among the children treated with amoxicillin-clavulanate than among those who received placebo: 4% versus 23% at or before the visit on day 4 or 5 (P<0.001) and 16% versus 51% at or before the visit on day 10 to 12 (P<0.001). Mastoiditis developed in one child who received placebo. Diarrhea and diaper-area dermatitis were more common among children who received amoxicillin-clavulanate. There were no significant changes in either group in the rates of nasopharyngeal colonization with nonsusceptible Streptococcus pneumoniae.. Among children 6 to 23 months of age with acute otitis media, treatment with amoxicillin-clavulanate for 10 days tended to reduce the time to resolution of symptoms and reduced the overall symptom burden and the rate of persistent signs of acute infection on otoscopic examination. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00377260.).

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Diarrhea; Female; Humans; Infant; Male; Nasopharynx; Otitis Media; Otoscopy; Prognosis; Recurrence; Regression Analysis; Streptococcus pneumoniae; Treatment Failure

The efficacy of antimicrobial treatment in children with acute otitis media remains controversial.. In this randomized, double-blind trial, children 6 to 35 months of age with acute otitis media, diagnosed with the use of strict criteria, received amoxicillin-clavulanate (161 children) or placebo (158 children) for 7 days. The primary outcome was the time to treatment failure from the first dose until the end-of-treatment visit on day 8. The definition of treatment failure was based on the overall condition of the child (including adverse events) and otoscopic signs of acute otitis media.. Treatment failure occurred in 18.6% of the children who received amoxicillin-clavulanate, as compared with 44.9% of the children who received placebo (P<0.001). The difference between the groups was already apparent at the first scheduled visit (day 3), at which time 13.7% of the children who received amoxicillin-clavulanate, as compared with 25.3% of those who received placebo, had treatment failure. Overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio, 0.38; 95% confidence interval [CI], 0.25 to 0.59; P<0.001) and the need for rescue treatment by 81% (6.8% vs. 33.5%; hazard ratio, 0.19; 95% CI, 0.10 to 0.36; P<0.001). Analgesic or antipyretic agents were given to 84.2% and 85.9% of the children in the amoxicillin-clavulanate and placebo groups, respectively. Adverse events were significantly more common in the amoxicillin-clavulanate group than in the placebo group. A total of 47.8% of the children in the amoxicillin-clavulanate group had diarrhea, as compared with 26.6% in the placebo group (P<0.001); 8.7% and 3.2% of the children in the respective groups had eczema (P=0.04).. Children with acute otitis media benefit from antimicrobial treatment as compared with placebo, although they have more side effects. Future studies should identify patients who may derive the greatest benefit, in order to minimize unnecessary antimicrobial treatment and the development of bacterial resistance. (Funded by the Foundation for Paediatric Research and others; ClinicalTrials.gov number, NCT00299455.).

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child, Preschool; Diarrhea; Double-Blind Method; Eczema; Female; Humans; Infant; Intention to Treat Analysis; Kaplan-Meier Estimate; Male; Otitis Media; Treatment Outcome

A randomized, double-blind, double-dummy, multicenter international study was conducted to assess the clinical and bacteriologic response, safety, and compliance of a single 60-mg/kg dose of azithromycin extended-release (ER) versus a 10-day regimen of amoxicillin/clavulanate 90/6.4 mg/kg per day in children with acute otitis media at high risk of persistent or recurrent middle ear infection.. Children aged 3 to 48 months were enrolled and stratified into two age groups (≤ 24 months and >24 months). Pretreatment tympanocentesis was performed at all sites and was repeated during treatment at selected sites.. The primary endpoint, clinical response at the test-of-cure visit in the bacteriologic eligible population, was achieved in 80.5% of children in the azithromycin ER group and 84.5% of children in the amoxicillin/clavulanate group (difference-3.9%; 95% confidence interval-10.4, 2.6). Bacteriologic eradication was 82.6% in the azithromycin ER group and 92% in the amoxicillin/clavulanate group (p=0.050). Children who received amoxicillin/clavulanate had significantly higher rates of dermatitis and diarrhea, a greater burden of adverse events, and a lower rate of compliance to study drug compared to those who received azithromycin ER.. A single 60-mg/kg dose of azithromycin ER provides near equivalent effectiveness to a 10-day regimen of amoxicillin/clavulanate 90/6.4 mg/kg per day in the treatment of children with acute otitis media.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child, Preschool; Double-Blind Method; Drug Administration Schedule; Humans; Infant; Otitis Media; Treatment Outcome

The need for alternative antimicrobial therapy for recurrent and persistent acute otitis media (AOM) in children has raised interest in assessing the efficacy and safety of fluoroquinolones for treatment of these infections.. In an evaluator-blinded, active-comparator, noninferiority, multicenter study, children (6 months to <5 years) were randomized 1:1 to receive levofloxacin (10 mg/kg twice daily) or amoxicillin/clavulanate (14:1; amoxicillin 45 mg/kg twice daily) for 10 days, with evaluations 4-6 days of therapy (visit 2), 2-5 days after completing therapy (visit 3), and 10-17 days after last dose (visit 4). Primary outcome was clinical cure at visit 3 based on resolution of clinical signs and symptoms of AOM.. A total of 1650 children were randomized and 1305 were clinically evaluable at visit 3 (630 levofloxacin, 675 comparator). Clinical cure rates were 72.4% (456 of 630) in levofloxacin-treated and 69.9% (472 of 675) in amoxicillin/clavulanate-treated children. Cure rates were also similar for levofloxacin and comparator for each age group (< or =24 months: 68.9% versus 66.2%; >24 months: 76.9% versus 75.1%; respectively). Cure rates at visit 4 were 74.9% and 73.8% in levofloxacin and amoxicillin/clavulanate groups, respectively. The upper limits of the confidence intervals were less than the noninferiority margin of 10% indicating that levofloxacin treatment is noninferior to comparator treatment overall and in both infants (6 months to 2 years) and children 2-5 years. No differences between treatment groups regarding the frequency or type of adverse events were apparent.. Levofloxacin was not inferior to amoxicillin/clavulanate for the treatment of recurrent and/or persistent AOM in infants and children.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child, Preschool; Female; Humans; Infant; Infant, Newborn; Levofloxacin; Male; Ofloxacin; Otitis Media; Treatment Outcome

Dynamics of bacteria during acute otitis media (AOM) has not been thoroughly studied because it requires repeated tympanocentesis. AOM with tympanostomy tube otorrhea provides a unique opportunity to study the appearance and disappearance of pathogens during the course of the disease without stressing the child.. Middle ear fluid (MEF) samples were taken before treatment (amoxicillin clavulanate or placebo) and then daily during follow-up from 75 children having AOM with otorrhea through a tympanostomy tube. Bacteria were identified by culture, and typical AOM pathogens also by polymerase chain reaction.. Bacteria were initially shown in 67 (89%) children. New bacteria appeared in MEF more often in placebo than in amoxicillin clavulanate recipients [9 of 38 (24%) versus 2 of 37 (5%); P = 0.032]. During the follow-up, new occurrences of Moraxella catarrhalis were detected in MEF more frequently than those of Streptococcus pneumoniae or Haemophilus influenzae. Of the 28 patients with bilateral otorrhea, 11 (39%) had disparate bacteria at study entry and/or during the follow-up.. Changes in bacterial findings during the course of AOM are common in patients not receiving treatment, and even possible despite adequate treatment. In bilateral otorrhea, disparate bacterial findings are common.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child, Preschool; Haemophilus influenzae; Humans; Infant; Middle Ear Ventilation; Moraxella catarrhalis; Otitis Media; Placebos; Streptococcus pneumoniae

Acute otitis media (AOM) is one of the most common acute bacterial infection in childhood and also the most frequent reason for outpatient antibiotic therapy. Little recent information about susceptibility patterns of AOM bacterial pathogens in Turkish children has been reported.. To determine the bacterial etiology of acute otitis media in children and to compare the efficiency of 3 days course of azithromycin with a 10 days course of amoxicillin-clavulanate.. This prospective, single blind, randomised comparative study was carried out in 180 children with AOM. Paracentesis was performed for middle ear fluid culture before the first dose antibiotic therapy. Children with acute otitis media were randomised to receive either low dose amoxicillin-clavulanate (45/6.4 mg/kg/day in two divided doses for 10 days) or low dose azithromycin (10mg/kg/day for 3 days). Clinical response was assessed on days 2-4, 11-13, 26-28.. Bacterial pathogens were isolated from 108 (60%) of 180 children. Streptococcus pneumoniae was the most common isolated pathogen (39.7%), followed by Haemophilus influenzae (20.7%), Moraxella catarrhalis (15.5%), Staphylococcus aureus (13.8%), Group A beta-hemolytic streptococcus (5.1%), Escherichia coli (3.4%) and Enterococcus faecalis (1.7%). This study demonstrated low resistance rates compared to studies of different countries. Although clinical response rates were better in patients treated with amoxicillin-clavulanate, this was not statistically significant [86.6% (78 of 90)] versus [95.2% (80 of 84)]. Success rates of amoxicillin-clavulanate were high for both S. pneumoniae and H. influenzae. Difference between success rates was not statistically significant (P=0.144 and 0.352).. Bacteria were isolated in 60% of AOM cases. The clinical efficiency of amoxicillin-clavulanate was found to be equal compared to azithromycin in children with acute otitis media.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Drug Administration Schedule; Drug Resistance, Bacterial; Female; Humans; Infant; Male; Otitis Media; Prospective Studies; Single-Blind Method; Treatment Outcome

To compare efficacy, tolerability, and parental satisfaction of cefdinir and high-dose amoxicillin/clavulanate oral suspensions given to young children with non-refractory acute otitis media (AOM) based on clinical endpoints and outcomes measures.. This was an investigator-blinded, multicenter study in which 318 children 6 months through 6 years of age with a clinical diagnosis of AOM were randomized to receive 10 days of either cefdinir (14 mg/kg divided BID) or high-dose amoxicillin/clavulanate (90/6.4 mg/kg divided BID).. Investigators evaluated clinical response at an end-of-therapy (EOT) office visit conducted on day 12-15. Outcomes of satisfaction, tolerability, and adherence were also assessed at that visit using an Otitis Parent Questionnaire.. The treatment groups were similar at baseline with respect to patient demographics. At the EOT visit, for cefdinir and amoxicillin/clavulanate, respectively, intent-to-treat (ITT) clinical cure rates were 82% (129/158) and 85% (134/158) (p = 0.547; 95% confidence interval [CI] -11.7 to 5.4) and per-protocol cure rates were 82% (123/150) and 90% (129/143) (p = 0.045; 95% CI -16.4 to 0.0). This difference was driven primarily by reduced cefdinir response in patients with recurrent AOM (p = 0.010) and those younger than 24 months (p = 0.039). Comparing cefdinir with amoxicillin/clavulanate, parents more often reported significantly better ease of use (89% vs. 57%; p < 0.0001), better taste (85% vs. 39%; p < 0.0001), and better adherence (at least 95% of doses) (82% vs. 61%; p < 0.0001). Diarrhea/loose stools were more common in the amoxicillin/clavulanate group than in the cefdinir group (28% vs. 18%, respectively; p = 0.0341). One patient in the cefdinir group and eight patients in the amoxicillin/clavulanate group withdrew from the study prematurely due to at least one adverse event (p = 0.0364). Study limitations included assessment of clinical recurrence by telephone call rather than office visit, exclusion of children with refractory AOM, and no assessment of middle ear microbiology.. Among young children with non-refractory AOM, cefdinir was as efficacious as high-dose amoxicillin/clavulanate in the ITT group, but somewhat less effective in per-protocol analysis. From the parental perspective, cefdinir was easier to administer, had a better taste, caused less diarrhea, and resulted in higher treatment adherence than high-dose amoxicillin clavulanate.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Cefdinir; Cephalosporins; Child; Child, Preschool; Dose-Response Relationship, Drug; Female; Humans; Infant; Male; Otitis Media; Parents; Prospective Studies; Treatment Outcome

Acute Otitis Media (AOM) is the most frequent respiratory tract infection of infancy and childhood that is treated with antimicrobial agents. The most common causative pathogens include Streptococcus pneumoniae, Hemophilus influenzae and Moxarella catarrhalis, and therefore antibacterial management should target against these isolates. Cefaclor, a congener of cephalexin monohydrate, is a semisynthetic cephalosporin antibiotic. It is an orally active cephalosporin which has demonstrated activity against a wide range of organisms in vitro. Present study is designed as a multicentric prospective trial to study and compare the efficacy and safety of cefaclor versus amoxicillin + clav in children with acute otitis media. One hundred and sixty seven patients were evaluated for efficacy endpoints in the cefaclor arm comprised of 104 males and 63 females with a mean age of 5.74+/-2.80 years and 185 patients in the amoxy-clav group comprised of 118 males and 67 females with a mean age of 4.93+/-2.92 years. Both cefaclor and amoxy-clav caused a significant improvement in all the signs and symptoms after a 10-day treatment period. However, between-the-group comparisons showed that the reduction in most of the symptoms was significantly more in cefaclor arm as compared to amoxicillin-clav arm. The clinical success (clinical cure + improvement) at the end of therapy was significantly more in cefaclor arm: 98% with cefaclor versus 85% with amoxicillin + clav, p<0.05 Table 3. Failure cases were prescribed other antibiotics according to the culture sensitivity reports, as rescue medication. Bacterial eradication rates were largely consistent with clinical responses. Bacteriological eradication was seen in 95% of patients in cefaclor group and 78% of patients in amoxicillin + clav group. In conclusion, cefaclor is a well tolerated and effective antibacterial option for acute otitis media in children and it is superior to the combination of amoxicillin + clav in efficacy and tolerability in acute AOM. Moreover, its expanded spectrum of activity, ability to achieve adequate concentrations in tissues, suitability for twice-daily dosing, and proven tolerability suggest that it is a good alternative to agents traditionally used in acute otitis media.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefaclor; Child; Child, Preschool; Female; Haemophilus influenzae; Humans; Infant; Male; Moraxella catarrhalis; Otitis Media; Prospective Studies; Streptococcus pneumoniae; Treatment Outcome

Decreased susceptibility of pathogens to currently used agents for recurrent otitis media has provided the impetus for identifying new antimicrobial options.. To compare gatifloxacin with amoxicillin/clavulanate in children with recurrent or nonresponsive acute otitis media (AOM).. Included in this multicenter randomized trial were 413 patients, ranging in age from 6 months to 7 years, who had recurrent AOM (at least 3 episodes in the previous 6 months or 4 episodes in the previous 12 months) and/or had failed antibiotic therapy for AOM within 14 days of enrollment. Diagnosis required evidence of acute inflammation and otoscopic findings of middle ear effusion; baseline tympanocentesis was optional and encouraged. Children were randomly assigned (2:1) to 10 days of oral therapy with gatifloxacin suspension (10 mg/kg of body weight once daily) or amoxicillin/clavulanate suspension (45/6.4 mg/kg/d in 2 divided doses).. : Clinical cure was obtained in 90.2% (222 of 246) of patients in the gatifloxacin group and 84.3% (102 of 121) of those in the amoxicillin/clavulanate group (95% confidence interval, -1.9-12.9) 3-10 days after treatment ended. Gatifloxacin was associated with higher clinical cure rates than was amoxicillin/clavulanate in children younger than 2 years of age (92.0% versus 80.0%, respectively). Cure rates by pretreatment pathogen in the gatifloxacin and amoxicillin/clavulanate groups were 92.1% (35 of 38) versus 88.9% (16 of 18) for Streptococcus pneumoniae infections and 88.2% (30 of 34) versus 92.3% (12 of 13) for Haemophilus influenzae infections, respectively. Sustained clinical cures 3-4 weeks after treatment ended were obtained in 74.4% (183 of 246) of patients treated with gatifloxacin and 72.7% (88 of 121) of those treated with amoxicillin/clavulanate. Adverse events considered drug-related occurred with similar frequency in the 2 groups. Six patients (2.2%) in the gatifloxacin group and 2 patients (1.5%) in the amoxicillin/clavulanate group developed transient symptoms of mild or moderate arthralgia.. In this comparative evaluation of fluoroquinolone therapy in children with AOM, gatifloxacin was similar in clinical efficacy to amoxicillin/clavulanate 45/6.4 mg/kg/d for treatment of recurrent/nonresponsive infections.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Child; Child, Preschool; Female; Fluoroquinolones; Gatifloxacin; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Male; Otitis Media; Pneumococcal Infections; Recurrence; Single-Blind Method; Streptococcus pneumoniae; Treatment Failure; Treatment Outcome

Recurrent otitis media and acute otitis media treatment failure are commonly encountered in the pediatric population.. To compare the clinical efficacy of gatifloxacin with amoxicillin/clavulanate for the treatment of acute otitis media treatment failure and recurrent otitis media.. Three hundred fifty-four children 6 months-7 years with recurrent otitis media and/or acute otitis media failure were stratified according to age (younger than 2 years versus 2 years or older) and then randomly assigned to 10 days of treatment with gatifloxacin 10 mg/kg once daily or amoxicillin/clavulanate 90 mg/6.4 mg in 2 divided doses. Tympanocentesis was performed in 116 children with acute otitis media treatment failure and 52 with recurrent otitis media at study entry to validate the clinical diagnosis and provide microbiologic data. The primary outcome measure was clinical resolution of infection at the test-of-cure visit 3-10 days after completing treatment.. Clinical resolution of acute otitis media was observed in 79.0% (49 of 62) of clinically evaluable children younger than 2 years and 90.3% (56 of 62) of those 2 years or older who were treated with gatifloxacin as compared with 77.6% (45 of 58) of children younger than 2 years and 79.7% (47 of 59) of children 2 years or older treated with amoxicillin/clavulanate. In patients with acute otitis media treatment failure, clinical response rates for children younger than 2 years and those 2 years or older were 87.5% (21 of 24) and 97.0% (32 of 33) with gatifloxacin versus 63.6% (14 of 22) and 83.9% (26 of 31) with amoxicillin/clavulanate. The corresponding clinical response rates in patients with recurrent otitis media were 79.2% (19 of 24) and 85.7% (18 of 21) with gatifloxacin and 90.5% (19 of 21) and 76.0% (19 of 25) with amoxicillin/clavulanate. Clinical success in those subjects having pretreatment middle ear fluid pathogens was similar for the 2 regimens [80.0% (24 of 30) gatifloxacin, 77.1% (27 of 35) amoxicillin/clavulanate]. Emergence of fluoroquinolone-resistant strains was not observed. Both drugs were generally well-tolerated. Diarrhea was the most common drug-related adverse event (10% gatifloxacin, 18% amoxicillin/clavulanate). No evidence of abnormal joint or gait findings was found during a 12-month follow-up.. Gatifloxacin once daily is at least as effective and well-tolerated as amoxicillin/clavulanate twice daily in children with acute otitis media treatment failure or recurrent otitis media. There was no evidence of arthrotoxicity or emergence of fluoroquinolone-resistant bacteria in gatifloxacin-treated children.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Child; Child, Preschool; Female; Fluoroquinolones; Gatifloxacin; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Male; Otitis Media; Pneumococcal Infections; Recurrence; Single-Blind Method; Streptococcus pneumoniae; Treatment Failure; Treatment Outcome

The effect on the nasopharyngeal bacterial flora of 10 days of amoxycillin-clavulanate or cefdinir antimicrobial therapy was studied in 50 children with acute otitis media. Before therapy, 17 potential pathogens (Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis) were isolated from the nasopharynx of 14 (56%) of those treated with amoxycillin-clavulanate, and 20 potential pathogens were recovered from 15 (60%) of those treated with cefdinir. Following therapy, at days 12-15, the number of potential pathogens was reduced to a similar extent with both therapies, to three in those treated with amoxycillin-clavulanate and two in those treated with cefdinir. However, the number of potential pathogens rebounded faster in those treated with amoxycillin-clavulanate as compared with cefdinir in the two subsequent specimens taken at days 30-35 and 60-65 (12 and 18 in the amoxycillin-clavulanate group, and six and nine in the cefdinir group, P < 0.01 and P < 0.001, respectively). Differences between the groups were also noted in the recovery of organisms with interfering capability. Immediately following amoxycillin-clavulanate therapy, the number of interfering organisms declined from 54 to 13, while following cefdinir treatment their number was reduced from 59 to 39 (P < 0.001). The differences between the two therapy groups persisted in the two later specimens taken at days 30-35 and 60-65 (25 and 38 in the amoxycillin-clavulanate group, and 52 and 51 in the cefdinir group, P < 0.001 and P < 0.05, respectively). This study illustrates the potential beneficial effect of using a narrow-spectrum antimicrobial that selectively spares the interfering organisms while eliminating pathogens. The benefit of such therapy is the prevention of reacquisition of pathogenic bacteria in the nasopharynx. In contrast, utilization of a broad-spectrum antimicrobial is associated with prolonged absence of inhibitory organisms and rapid recolonization with pathogens.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefdinir; Cephalosporins; Child; Colony Count, Microbial; Haemophilus influenzae; Humans; Moraxella catarrhalis; Nasopharynx; Otitis Media; Streptococcus pneumoniae; Time Factors

A large dosage pediatric formulation of amoxicillin/clavulanate with an improved pharmacokinetic/pharmacodynamic profile was developed to eradicate many penicillin-resistant strains of Streptococcus pneumoniae and Haemophilus influenzae (including beta-lactamase-producing strains).. This randomized, investigator-blinded, multicenter trial examined treatment of bacterial acute otitis media (AOM) in children 6-30 months of age with amoxicillin/clavulanate (90/6.4 mg/kg/d in 2 divided doses for 10 days) versus azithromycin (10 mg/kg for 1 day followed by 5 mg/kg/d for 4 days). Tympanocentesis was performed at entry for bacteriologic assessment, at the on-therapy visit (day 4-6) to determine bacterial eradication and at any time before the end-of-therapy visit (day 12-14) if the child was categorized as experiencing clinical failure. Clinical assessments were performed at the on-therapy, end-of-therapy and follow-up (day 21-25) visits.. We enrolled 730 children; AOM pathogens were isolated at baseline for 249 of the amoxicillin/clavulanate group and 245 of the azithromycin group. For children with AOM pathogens at baseline, clinical success rates at the end-of-therapy visit were 90.5% for amoxicillin/clavulanate versus 80.9% for azithromycin (P < 0.01), and those at the on-therapy and follow-up visits were 94.9% versus 88.0% and 80.3% versus 71.1%, respectively (all P < 0.05). At the on-therapy visit, pretherapy pathogens were eradicated for 94.2% of children receiving amoxicillin/clavulanate versus 70.3% of those receiving azithromycin (P < 0.001). Amoxicillin/clavulanate eradicated 96.0% of S. pneumoniae (92.0% of fully penicillin-resistant S. pneumoniae) and 89.7% of H. influenzae (85.7% [6 of 7 cases] of beta-lactamase-positive H. influenzae). Corresponding rates for azithromycin were 80.4% (54.5%) for S. pneumoniae and 49.1% (100% [1 of 1 case]) for H. influenzae (all P < 0.01 for between-drug comparisons).. Amoxicillin/clavulanate was clinically and bacteriologically more effective than azithromycin among children with bacterial AOM, including cases caused by penicillin-resistant S. pneumoniae and beta-lactamase-positive H. influenzae.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child, Preschool; Female; Haemophilus influenzae; Humans; Infant; Male; Microbial Sensitivity Tests; Otitis Media; Penicillin Resistance; Streptococcus pneumoniae; Treatment Outcome

Streptococcus pneumoniae (Sp) and Haemophilus influenzae (Hi) are the leading bacterial cause of acute otitis media (AOM), having the nasopharynx (NP) as their reservoir. In October 2001 we began a prospective, multicenter, randomized, evaluator blind study, comparing the efficacy of amoxicillin-sulbactam (Ax/S) and amoxicillin-clavulanic acid (Ax/C) for the treatment of non-recurrent AOM (nr-AOM). Both antimicrobial susceptibility (AS) to Ax/S and Ax/C from Sp and Hi carried by study children (aged 6-48 months with nr-AOM) and, clinical outcome after treatment with high dose of either Ax/C (7:1) or Ax/S (4:1) (amoxicillin dose: 80 mg/(kg day), b.i.d. for 10 days) were assessed. Nasal cultures (NCs) were taken at Day 0. Follow-up NCs, were done only for Sp carriers. On final analysis 247/289 pts (85.5%) were fully evaluable (120 Ax/S and 127 Ax/C). NP carriage rate of Hi and Sp at Day 0 was 32.2% (93/289 pts) and 28.7% (83/289 pts), respectively. Persistent Sp carriage was detected only in 2 pts. Hi betalactamase positive rate was 13% (12/93). MICs for Ax/S and Ax/C were identical when tested against Sp and Hi isolates (range < or = 0.016-1.0 and < or = 0.016-0.25 mg/L, respectively). Clinical efficacy at Days 12-14 and 28-42 were 98.3% (115/117) and 94.2% (97/103) for Ax/S; and 98.3% (115/117) and 95.1% (98/103) for Ax/C, respectively (pNS). We conclude, that Sp and Hi isolated from NCs of nr-AOM pts were highly sensitive to both drugs and correlated with high clinical efficacy rate.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Argentina; Carrier State; Child, Preschool; Drug Administration Schedule; Drug Combinations; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Male; Otitis Media; Pneumococcal Infections; Prospective Studies; Single-Blind Method; Streptococcus pneumoniae; Sulbactam; Treatment Outcome

In order to evaluate the clinical efficacy and safety profiles of single-dose ceftriaxone (50 mg/kg, not exceeding 1 g) and a 10-day course of amoxicillin-clavulanate (amoxi-clav) [45 mg/kg/day, in 3 divided doses] in children with acute otitis media (AOM), we conducted a prospective, comparative, randomized trial. Between February 2000 and April 2002, 110 children with a mean age of 30.73 +/- 20.79 months were enrolled. 109 patients were evaluated for the safety assessment. The intent-to treat population included 96 patients who completed at least 3 days of treatment. The standard analysis population included 73 patients who completed the 10-day treatment period without any major violation. For the standard analysis population, 57 out of 73 patients experienced treatment success; 31 out of 41 patients in the ceftriaxone group were cured compared with 25 out of 32 patients in the amoxi-clav group. The rate of persistence of middle-ear fluid did not differ between the 2 groups at day 11 or day 28. A higher treatment preference rate was observed in the ceftriaxone group (93.9% vs 58.6%). The most common drug-related adverse effects were found in the digestive system, skin and appendages in both treatment groups. A single dose of ceftriaxone is as safe and effective as amoxi-clav for curing patients with acute otitis media. In addition, a substantially higher proportion of patients receiving single-dose ceftriaxone showed a preference for the study medication compared with those treated with amoxi-clav for 10 days.

Topics: Acute Disease; Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Ceftriaxone; Child; Child, Preschool; Female; Humans; Infant; Injections, Intramuscular; Male; Otitis Media; Prospective Studies; Treatment Outcome

Short course beta-lactam antibiotic therapy for acute otitis media (AOM) should improve patient adherence, but it has not been evaluated since the heptavalent pneumococcal conjugate vaccine became routinely used in the United States.. In a prospective, investigator-blinded, multicenter study, 425 patients, age 6 months-6 years, with a clinical diagnosis of nonrefractory AOM were randomized to receive either 5 days of cefdinir therapy (14 mg/kg divided twice daily) or 10 days of amoxicillin/clavulanate therapy (45/6.4 mg/kg divided twice daily). Clinical response was assessed at end of therapy (2-4 days postantibiotic, respectively) and week 4 (study days 25-28).. With no difference in demographics between treatment groups, overall the mean age (+/-SD) was 2.8 +/- 1.8 years, 65% had received conjugated pneumococcal vaccination and 48% had bilateral AOM. The satisfactory clinical response rate at end of therapy was comparable for cefdinir versus amoxicillin/clavulanate (88%, 170 of 194 versus 85%, 164 of 192; 95% CI -4.9, 9.3). Although this must be interpreted with caution, cefdinir showed an apparent trend for higher efficacy than amoxicillin/clavulanate (92%, 72 of 78 versus 77%, 55 of 71; P = 0.019) in a subsample of patients 6-24 months old who had received conjugated pneumococcal vaccination. The incidence of drug-related adverse events was less for cefdinir than for amoxicillin/clavulanate (24%, 50 of 211 versus 38%, 82 of 214; P = 0.0018). For children with nonrefractory AOM, based only on clinical endpoints, 5 days of therapy with cefdinir 14 mg/kg divided twice daily was comparable overall with 10 days of therapy with low dose amoxicillin/clavulanate 45/6.4 mg/kg divided twice daily.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Cefdinir; Cephalosporins; Child; Child, Preschool; Confidence Intervals; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media; Probability; Prospective Studies; Reference Values; Risk Assessment; Single-Blind Method; Treatment Outcome

To compare parent-reported outcomes (satisfaction, tolerability, compliance, and work/daycare missed) for children (aged 6 months to 6 years) receiving either cefdinir or amoxicillin/clavulanate for acute otitis media.. In a phase IV, investigator-blinded, parallel-group, randomized, multicenter study, parents or legal guardians were asked to complete the Otitis Parent Questionnaire (OPQ) 12-14 days after the first dose of cefdinir or amoxicillin/clavulanate oral suspensions. Responses in each of the outcome domains were analyzed using non-parametric statistical analysis.. Of 367 parents/guardians who completed the questionnaire, better ease of use (p = 0.009) and taste (p < 0.0001) were associated with cefdinir versus amoxicillin/clavulanate treatment, and children were significantly more likely to experience vomiting with amoxicillin/clavulanate (16% vs 8%; p = 0.016). Parents also reported that their children were much more likely to take all of their medication if receiving cefdinir (68% vs 53% for amoxicillin/clavulanate; p = 0.005). There were no statistically significant differences between groups in work/daycare missed.. Based on parents' assessment using the OPQ, cefdinir was easier to administer and tasted better than amoxicillin/clavulanate. Children who received cefdinir also experienced less vomiting and had greater compliance than children who received amoxicillin/clavulanate.

Topics: Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Cefdinir; Cephalosporins; Child; Child, Preschool; Clinical Trials, Phase IV as Topic; Drug Tolerance; Female; Humans; Infant; Male; Otitis Media; Parents; Patient Compliance; Patient Satisfaction; Randomized Controlled Trials as Topic; Surveys and Questionnaires; Suspensions; Treatment Outcome

Compared with 5 days of dosing, a 3 day dosing regimen of azithromycin for treatment of acute otitis media (AOM) may improve compliance, will simplify therapy for the caregiver and, by giving the same total dose as the 5 day regimen, provide more drug when the bacterial burden is highest.. Children of 6 months-12 years were enrolled if they had had symptoms and signs of AOM for <4 weeks and tympanic membrane effusion by acoustic reflectometry. Eligible children were randomized to azithromycin 10 mg/kg/day x 3 days or co-amoxiclav 45 mg/kg/day x 10 days. The primary endpoint was clinical response at day 28.. One hundred and eighty-eight children (mean age 3.5 years) were randomized to azithromycin and 185 to co-amoxiclav. At day 10, the clinical success rate was 153/185 (83%) in children treated with azithromycin and 159/181 (88%) in children treated with co-amoxiclav. At day 28, 134/182 (74%) of the children were cured on azithromycin compared with 124/180 (69%) on co-amoxiclav. Also at day 28, signs of AOM, such as abnormal reflectometry (45% versus 59%; P = 0.017), bulging of the eardrum (10% versus 16%; P = 0.059) and loss of tympanic membrane landmarks (11% versus 22%; P = 0.010) were seen less frequently in azithromycin- than co-amoxiclav-treated children, respectively. Adverse events related to therapy were seen in 11% of azithromycin patients compared with 20% on co-amoxiclav (P = 0.014).. Azithromycin given over 3 days is as effective as co-amoxiclav for treatment of AOM, may result in more complete resolution of tympanic membrane disease, and is better tolerated.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child, Preschool; Double-Blind Method; Drug Therapy, Combination; Female; Hearing Tests; Humans; Infant; Male; Otitis Media; Treatment Outcome; Tympanic Membrane

Infants and young children, especially those in day care, are at risk for recurrent or persistent acute otitis media (AOM). There are no data on oral alternatives to high-dose amoxicillin-clavulanate for treating AOM in these high-risk patients. In this double-blind, double-dummy multicenter clinical trial, we compared a novel, high-dose azithromycin regimen with high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent AOM. Three hundred four children were randomized; 300 received either high-dose azithromycin (20 mg/kg of body weight once a day for 3 days) or high-dose amoxicillin-clavulanate (90 mg/kg divided twice a day for 10 days). Tympanocentesis was performed at baseline; clinical response was assessed at day 12 to 16 and day 28 to 32. Two-thirds of patients were aged < or =2 years. A history of recurrent, persistent, or recurrent plus persistent AOM was noted in 67, 18, and 14% of patients, respectively. Pathogens were isolated from 163 of 296 intent-to-treat patients (55%). At day 12 to 16, clinical success rates for azithromycin and amoxicillin-clavulanate were comparable for all patients (86 versus 84%, respectively) and for children aged < or =2 years (85 versus 79%, respectively). At day 28 to 32, clinical success rates for azithromycin were superior to those for amoxicillin-clavulanate for all patients (72 versus 61%, respectively; P = 0.047) and for those aged < or =2 years (68 versus 51%, respectively; P = 0.017). Per-pathogen clinical efficacy against Streptococcus pneumoniae and Haemophilus influenzae was comparable between the two regimens. The rates of treatment-related adverse events for azithromycin and amoxicillin-clavulanate were 32 and 42%, respectively (P = 0.095). Corresponding compliance rates were 99 and 93%, respectively (P = 0.018). These data demonstrate the efficacy and safety of high-dose azithromycin for treating recurrent or persistent AOM.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Otitis Media; Patient Compliance; Penicillins; Recurrence; Treatment Outcome

To assess the equivalence of amoxicillin/clavulanic acid and placebo in the prevention of acute otitis media in children at high risk of acute otitis media who develop upper respiratory tract infection.. This was a multicentre, equivalence, randomized, double-blind trial of two parallel groups comparing 5 days of amoxicillin/clavulanic acid 75 mg kg-1 day-1 (i.e. 25 mg kg-1 every 8 h) and placebo. The main outcome measure was acute otitis media occurring within 8-12 days of initiating treatment.. Two hundred and three infants, aged 3 months-3 years with upper respiratory tract infection over 36 h and a history of recurrent acute otitis media were included over 8.5 months. Two children were lost to follow-up. Patient characteristics were similar in both groups. In the intention to treat analysis the frequency of acute otitis media was 16.2% (16/99) in the placebo group and 9.6% (10/104) in the amoxicillin/clavulanic acid group (P = 0.288). The difference between acute otitis media rates was 6.6% (one-sided 95% confidence interval of 14.3%). The occurrence of side-effects was similar in the amoxicillin/clavulanic acid and placebo groups.. The difference in effectiveness between antibiotic and placebo was not greater than 14.3%, and we calculated that 94 children would need to be exposed to antibiotics to avoid six cases of acute otitis media. In view of the risk of development of resistance due to frequent exposure to antibiotics, our study supports the need for reduction in the administration of antibiotics in upper respiratory tract infection even in children at high risk of acute otitis media.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Child, Preschool; Double-Blind Method; Drug Therapy, Combination; Humans; Infant; Otitis Media; Recurrence; Respiratory Tract Infections; Risk Factors; Treatment Outcome; Virus Diseases

To study the effect of recolonisation with alpha streptococci with the ability to inhibit the growth of otopathogens ("interfering" activity) on the recurrence of acute otitis media in susceptible children and the effect on the frequency of secretory otitis media.. Double blind, randomised, placebo controlled study.. Ear, nose, and throat clinic with three doctors.. 130 children prone to otitis media aged between 6 months and 6 years, 108 of whom were eligible and followed for 3 months.. Recurrence of otitis media during follow up and a normal tympanic membrane at the last valid visit.. Children with no recurrences during the last month received phenoxymethylpenicillin (n=22), and those with a recurrence within 1 month received amoxicillin clavulanic acid (n=86), both twice daily for 10 days. These were followed by a streptococcal or placebo solution sprayed into the nose for a further 10 days. At day 60 the same spray was started for another 10 days.. At 3 months 22 children (42%) given the streptococcal spray were healthy and had a normal tympanic membrane compared with 12 (22%) of those given placebo. This difference was shown separately for recurrences of both acute otitis media and secretory otitis media.. Selected bacteria with the ability to inhibit the growth of common otopathogens can be used to protect against recurrent acute otitis media and secretory otitis media in children.

Topics: Aerosols; Amoxicillin-Potassium Clavulanate Combination; Antibiosis; Child; Child, Preschool; Combined Modality Therapy; Double-Blind Method; Follow-Up Studies; Humans; Infant; Otitis Media; Otitis Media with Effusion; Penicillin V; Recurrence; Streptococcus

Antibiotic-resistant pneumococci are difficult to eradicate from middle ear fluid (MEF) and the nasopharynx (NP). Bacteriologic eradication from the NP and MEF during acute otitis media (AOM) by 3 common antibiotic drugs was prospectively evaluated. In 19 (16%) of 119 MEF culture-positive patients, an organism susceptible to the treatment drug (Haemophilus influenzae, Streptococcus pneumoniae, or both) was isolated from the initial MEF, whereas resistant S. pneumoniae was present in the NP; in 9 (47%) patients, the initial resistant NP organism (identified by serotyping, resistance to the administered drug, and pulsed-field gel electrophoresis) replaced the susceptible MEF organism within only a few days after initiation of treatment. In regions where resistant pneumococci are prevalent, antibiotics may not only fail to eradicate the organisms, but they may often induce MEF superinfection with resistant pneumococci initially carried in the NP. This is an important mechanism by which, in recently treated patients, AOM infections often become refractory to treatment.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Drug Resistance, Microbial; Drug Therapy, Combination; Ear, Middle; Female; Humans; Male; Nasopharynx; Otitis Media; Pneumococcal Infections; Serotyping; Streptococcus pneumoniae; Superinfection; Time Factors; Trimethoprim, Sulfamethoxazole Drug Combination

The recommendation of the Drug-Resistant Streptococcus pneumoniae Therapeutic Working Group that high-dose amoxicillin, with or without clavulanate, be used to treat acute otitis media (AOM) addressed concerns about the efficacy of existing therapies against drug-resistant S. pneumoniae. This recommendation relied on pharmacodynamic predictions of concentrations of amoxicillin in middle-ear fluid remaining higher than minimum inhibitory concentrations against intermediately resistant S. pneumoniae for >40% of the dosing interval.. This study compared the tolerability and efficacy of cefprozil and high-dose amoxicillin/clavulanate in patients with AOM.. Patients were randomized to receive 10 days of investigator-blinded oral treatment with either cefprozil suspension (30 mg/kg/d in 2 divided doses) or amoxicillin/clavulanate (45/6.4 mg/kg/d) plus amoxicillin (45 mg/kg/d) in 2 divided doses. The primary efficacy end point was the clinical cure rate 4 to 7 days after the end of treatment. Clinical response by age (6 months-<2 years vs > or =2-7 years), disease severity, and unilateral versus bilateral ear infection was also examined. The primary measures of tolerability were the frequency and severity of adverse events and their relation to study drug. Adverse events were either spontaneously reported or elicited during examination and questioning of the patient. Identified adverse events were coded and recorded using the COSTART (Coding Symbols for Thesaurus of Adverse Reaction Terms) system.. Three hundred four children between the ages of 6 months and 7 years with > or =1 sign or symptom of AOM were enrolled in the study, and 303 (150 cefprozil, 153 amoxicillin/clavulanate) were treated. Twenty-three patients in each treatment group were not evaluable; thus, 257 children were included in the analysis of evaluable patients. Clinical cure rates were 87% (110/127) with cefprozil and 89% (116/130) with amoxicillin/clavulanate (95% CI for the difference in cure rate, -10.7% to 4.1%). No between-group differences in efficacy were noted by age, disease severity, or unilateral or bilateral involvement. The overall incidence of drug-related adverse events was significantly lower with cefprozil than with amoxicillin/clavulanate (19% vs 32%, respectively; P = 0.008), as was the incidence of diarrhea (9% vs 19%, respectively; P = 0.021). Adverse events prompted discontinuation of therapy in 4 (3%) cefprozil patients and 8 (5%) amoxicillin/clavulanate patients.. Based on a search of MEDLINE, this study is the first direct comparison of cefprozil versus high-dose amoxicillin/clavulanate. Cefprozil was as effective as high-dose amoxicillin/clavulanate, with a lower incidence of adverse events.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefprozil; Cephalosporins; Child; Child, Preschool; Drug Therapy, Combination; Drug Tolerance; Female; Humans; Infant; Male; Otitis Media; Single-Blind Method

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

The effect of antimicrobial therapy with amoxycillin (AMX) or co-amoxiclav (AMC) on the adenoid bacterial flora of 45 children with recurrent otitis media (ROM), scheduled for elective adenoidectomy, was studied. Patients were randomized before surgery into three groups of 15, having had either no antibiotic therapy (control), or 10 days of therapy with AMX or AMC. Core adenoid tissues were quantitatively cultured for aerobic and anaerobic bacteria. Polymicrobial aerobic-anaerobic flora was present in all instances. The predominant aerobes in all groups were alpha-haemolytic and non-haemolytic streptococci, Haemophilus influenzae, Staphylococcus aureus, group A beta-haemolytic streptococci and Moraxella catarrhalis. The prominent anaerobes were Peptostreptococcus spp., Prevotella spp. and Fusobacterium spp. The number of isolates was significantly reduced in those treated with AMX (110; P < 0.05) or AMC (54; P < 0.001) compared with control (148). The number of bacteria per gram of tissue was lower in those treated with both antibiotics. The number of potential pathogens was lower in those treated with AMC compared with the other two groups (P < 0.001 ). The number of beta-lactamase- producing bacteria (BLPB) was lower in those treated with AMC compared with those treated with AMX (P < 0.025) or no antibiotic (P < 0.001). These data illustrate the ability of AMX and AMC to reduce the bacterial load as well as potential pathogens and BLPB from the adenoids of children with ROM.

Topics: Adenoids; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteria, Aerobic; Bacteria, Anaerobic; Child; Child, Preschool; Drug Therapy, Combination; Female; Humans; Male; Otitis Media; Penicillins

To determine the bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate (90/6.4 mg/kg/day) against common bacterial pathogens causing acute otitis media (AOM), including penicillin-resistant Streptococcus pneumoniae (PRSP).. In this open label multicenter study, 521 infants and children with AOM [mean age, 18.6 months; age < 24 months, n = 375 (72%)] were treated with amoxicillin/clavulanate 90/6.4 mg/kg/day in two divided doses for 10 days. Bilateral otitis media, previous episodes of AOM, antibiotic treatment within 3 months and day-care attendance were recorded in 60.1, 35.7, 50.2 and 38.2% of the children, respectively. Tympanocentesis was performed before the first dose and repeated on Days 4 to 6 for all children with S. pneumoniae at 22 centers and for all children with any pathogen at 3 centers. Clinical response was assessed at end of therapy.. Pathogens were isolated from 355 (68%) of 521 enrolled children; 180 children underwent repeat tympanocentesis and were bacteriologically evaluable. Baseline pathogens were S. pneumoniae (n = 122 enrolled/93 bacteriologically evaluable), Haemophilus influenzae (n = 160/51), both (n = 37/32) and others (n = 36/4). Pathogens were eradicated from 172 (96%) of 180 bacteriologically evaluable children. Overall 122 (98%) of 125 isolates of S. pneumoniae were eradicated, including 31 (91%) of 34 PRSP isolates (penicillin MICs 2 to 4 micrograms/ml). Seventy-eight (94%) of 83 isolates of H. influenzae were eradicated. Symptoms and otoscopic signs of acute inflammation were completely resolved or improved on Days 12 to 15 in 263 (89%) of 295 clinically evaluable children with bacteriologically documented AOM.. On the basis of bacteriologic outcome on Days 4 to 6 and clinical outcome on Days 12 to 15, we found that high dose amoxicillin/clavulanate (90/6.4 mg/kg/day) was highly efficacious in children with AOM, including those most likely to fail treatment, namely children < 24 months of age and those with infectious caused by PRSP.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Child, Preschool; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Haemophilus influenzae; Humans; Infant; Male; Microbial Sensitivity Tests; Otitis Media; Penicillin Resistance; Streptococcus pneumoniae; Treatment Outcome

This multicenter, randomized open-label study compared the efficacy and safety of roxithromycin tablets 300 mg once a day (Rx) and amoxicillin/clavulanic acid tablets 875+125 mg twice a day (Acx), administered for a mean of 7 days. The study was carried out in five centers on 100 in- or out-patients of both sexes, aged between 18 and 91 years (mean 38+/-14). All patients suffered from ENT diseases, 85% with acute otitis media, 31% pharyngotonsillitis and 11% rhinosinusitis. The patients were divided into two randomized groups of 50 patients each. Clinical evaluations (signs and symptoms) were performed before, during and at the end of therapy. At the end of therapy, for intent-to-treat and per-protocol populations, a satisfactory overall clinical response was achieved by 82% of patients in the Rx group and 78% in the Acx group with similar reductions in signs and symptoms of disease in both groups. Safety was good, with only 2 patients of the Rx group and 4 patients of the Acx group presenting side effects, involving mainly the gastrointestinal system. Rx appears to be active and safe in the therapy of ENT diseases exhibiting similar effects on the reduction of signs and symptoms as Amx but with better compliance because of once-a-day administration.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Drug Resistance; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Otitis Media; Pharyngitis; Roxithromycin; Sinusitis

This multicenter, randomized, single-blind study compared the efficacy and safety of a new, twice-daily formulation of amoxycillin/clavulanate (Augmenting) with the standard three-times-daily formulation. Children with a clinical diagnosis of acute otitis media, aged between 2 months and 12 years, received either amoxycillin/clavulanate 45/6.4 mg/kg/day twice-daily (b.d.) (range 38.3/5.5-76.2/10.9 mg/kg/day) or amoxycillin/clavulanate 40/10 mg/kg/day three-times-daily (t.d.s.) (range 25/6.25-56/14 mg/kg/day) for 7 or 10 days. Patients were evaluated during therapy (Days 3-5), at the end of therapy (Days 7-12) and at follow-up (Days 38-42). At the end of therapy, for the intent-to-treat and per-protocol populations, respectively, clinical success (cure) was achieved by approximately 94% of patients in both treatment groups. A successful bacteriological response at the end of therapy (Visit 3) was documented in 7/9 patients (77.8%) in the twice-daily group and in 11/13 patients (84.6%) in the three-times-daily group. At follow-up (Visit 4), 93.3% of patients in the twice-daily group and 87.9% in the three-times-daily group continued to have a clinically successful response. Both treatment regimens were well tolerated, with most adverse events being of a mild-moderate and transient nature. The most common treatment-related adverse event was diarrhea, occurring in 7.2% of patients in the twice-daily group and in 10.7% of the three-times-daily group. In total, 173 patients (82.8%) in the twice-daily group and 151 patients (73.3%) in the three-times-daily group were compliant with medication. In conclusion, this study confirms that b.d. amoxycillin/clavulanate is an effective treatment for pediatric acute otitis media and demonstrates that the b.d. and t.d.s. formulations of amoxycillin/clavulanate produce equivalent efficacy. Furthermore, there was a trend towards a higher level of compliance and a lower incidence of drug-related adverse events in the twice-daily compared with the three-times-daily treatment group.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Chemistry, Pharmaceutical; Child; Child, Preschool; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Patient Compliance; Single-Blind Method; Treatment Outcome

A comparative trial was performed of two regimens of antibiotic therapy in acute otitis, exacerbation of otitis media chronica and sinusitis in children. 100 children received combined treatment with amoxycilline and clavulanic acid (amoxiclav and autmentin). 50 control children were i.m. injected ampicilline. Oral co-amoxiclavs proved highly effective in ENT diseases in children and are superior to intramuscular ampicilline.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Child; Chronic Disease; Drug Administration Routes; Drug Therapy, Combination; Follow-Up Studies; Humans; Otitis Media; Penicillins; Retrospective Studies; Sinusitis; Treatment Outcome

We compared colonization and resistance rates of non-pneumococcal alpha-hemolytic streptococci (AHS) and Streptococcus pneumoniae in children receiving antibiotic therapy for acute otitis media.. Between December 1997 and September 1998, children 6 months to 6 years of age, diagnosed with acute otitis media were randomly assigned to receive amoxicillin/clavulanate (Augmentin) 45 mg/kg/d in 2 divided doses for 10 days or azithromycin (Zithromax), 10 mg/kg, once on the first day, followed by 5 mg/kg daily for 4 days. Nasopharyngeal swabs for culture were obtained before and at 2 weeks and 2 months after the start of therapy. Streptococci were identified by species, and antibiotic susceptibility was determined by the epsilometric test.. One hundred six children completed the 2-week follow-up and 2-month follow-up, respectively. The nasopharyngeal carriage rate of non-pneumococcal AHS increased from 14% before treatment to 32% at the 2-week follow-up (P =.02) and was similar in both treatment groups. In contrast, the carriage of S pneumoniae decreased from 51% before therapy to 27% at the 2-week follow-up (P =.002). The carriage of penicillin-resistant AHS strains (minimum inhibitory concentration > 1 microg/mL) increased from 9% before treatment to 26% at 2 weeks and 36% at 2 months.. Amoxicillin/clavulanate and azithromycin therapy resulted in increased isolation of nasopharyngeal non-pneumococcal AHS, many of which were multidrug-resistant, in contrast to a decrease in pneumococcal carriage. This suggests that the competitive balance between these 2 groups of organisms was disturbed as a result of differential antibiotic susceptibility. The importance of drug-resistant AHS as a reservoir for resistance genes for S pneumoniae warrants further investigation.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; beta-Lactam Resistance; Child, Preschool; Drug Resistance, Multiple; Drug Therapy, Combination; Female; Humans; Infant; Male; Nasopharynx; Otitis Media; Streptococcus; Streptococcus pneumoniae

A multicentre, open-label, randomized study was performed in 501 out-patients with acute otitis media, aged 6-36 months, to study the impact of treatment with either cefixime suspension 8 mg/kg/day bd or co-amoxiclav suspension 80 mg/kg/day tds for 10 days on nasopharyngeal carriage of Streptococcus pneumoniae and Haemophilus influenzae. Of 426 patients with nasopharyngeal cultures at entry to the trial, end of treatment and at follow-up visit (35 days after inclusion), significant changes in carriage of S. pneumoniae were observed. The proportion of penicillin-resistant S. pneumoniae was higher in the samples taken at the end of treatment and follow-up than in those taken at inclusion, while the total number of children with this microorganism was lower. The difference at the end of treatment was greater with co-amoxiclav than with cefixime. For H. influenzae the resistance rate remained steady while the number of children with this microorganism decreased. At follow-up there was no significant difference between the two groups in terms of nasopharyngeal positive culture for S. pneumoniae or H. influenzae. Despite these differences, successful clinical responses were similar at the end of treatment and at follow-up.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; beta-Lactam Resistance; Cefixime; Cefotaxime; Cephalosporins; Child, Preschool; Female; Haemophilus influenzae; Humans; Infant; Male; Microbial Sensitivity Tests; Nasopharynx; Otitis Media; Streptococcus pneumoniae; Treatment Outcome

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Diarrhea; Double-Blind Method; Drug Resistance, Microbial; Drug Therapy, Combination; Female; Gastroenteritis; Humans; Infant; Male; Otitis Media; Pneumococcal Infections; Streptococcus pneumoniae

In this randomized, multicenter, observer-blind study, the efficacy, safety and tolerability of amoxycillin/clavulanate and cefaclor were compared in children with a clinical diagnosis of acute otitis media. Patients aged between 1 and 12 years received either amoxycillin/clavulanate (250 mg/62 mg t.i.d., or 125 mg/31 mg t.i.d. if aged under 6 years) or cefaclor (250 mg t.i.d., or 125 mg t.i.d. if aged under 6 years) for 7 days. The amoxycillin/clavulanate regimen was based on a dose of 20/5 mg/kg/day (representing 20 mg amoxycillin plus 5 mg clavulanic acid) in three divided doses. Patients were followed-up at the end of therapy and on days 10-12 and 38-40. At the end of the study (days 38-40), clinical success rates were 91.4% for amoxycillin/clavulanate and 78.6% for cefaclor. The difference was statistically significant (p = 0.008). After the 7 days of treatment, 3 patients (2.9%) in the amoxycillin/clavulanate group had clinical failure, compared with 18 patients (16.1%) in the cefaclor group (p < 0.001). Both treatments were well tolerated and there were no statistically significant differences between the groups in adverse event profiles. The incidence of diarrhea was low (7.0% amoxycillin/clavulanate, 8.4% cefaclor) and was generally of mild or moderate intensity. The study demonstrated that amoxycillin/clavulanate was significantly more effective clinically than cefaclor in the treatment of acute otitis media in children.

Topics: Acute Disease; Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Cefaclor; Cephalosporins; Child; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Single-Blind Method; Treatment Outcome

Use of a beta-lactamase stable antibiotic is called for in cases of acute otitis media (AOM) likely to be caused by beta-lactamase-producing Haemophilus influenzae or Moraxella catarrhalis. Two beta-lactamase-stable agents commonly used for empirical treatment of AOM are amoxicillin/clavulanate and cefixime.. A multicenter, randomized clinical trial compared cefixime (CFX; 8 mg/kg once daily) with amoxicillin/clavulanate (A/C; 40 mg/kg/day in three divided doses) for the treatment of children with AOM. Three hundred thirteen children were randomly assigned to a 10-day course of either CFX (n = 158) or A/C (n = 155). Based on history, physical examinations and otoscopic and tympanometric assessments, clinical responses were evaluated as cure, improvement, failure, relapse or nonevaluable. Compliance and patient/parent acceptability were also analyzed.. Overall favorable clinical responses (cure plus improvement) were comparable post-therapy for the two treatments (CFX = 76%; A/C = 77%). Significant differences in response rates for both treatments were noted among different geographic regions, with the highest response rates observed in the Northeast and South. Acceptability of CFX was significantly better than that of A/C (P = 0.0001), and the adverse experience rate was lower (P = 0.001). The most frequently reported adverse experiences were diarrhea (CFX 15.2%, A/C 29.7%) and vomiting (CFX 3.2%, A/C 10.32%). Relapse rates were 26% for CFX and 29% for A/C.. This study demonstrated that CFX has comparable clinical efficacy and a better adverse events profile than A/C when used to treat AOM of childhood.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefixime; Cefotaxime; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Prospective Studies; Treatment Outcome

To compare the safety and efficacy, in treating acute otitis media (AOM) in children, of a new formulation of amoxicillin/clavulanate potassium (Augmentin) oral suspension providing 45/6.4 mg/kg/day and administered twice daily (bid) for 5 and 10 days, respectively, with the safety and efficacy of the original formulation providing 40/10 mg/kg/day and administered three times daily (tid) for 10 days.. Eight hundred sixty-eight children ages 2 months to 12 years with AOM were randomly assigned to one of the three treatment groups. Stringent criteria were used for the diagnosis of AOM and for determinations of "cure" and "improvement." Subjects were reexamined on Days 12 to 14 and 32 to 38.. Among subjects whose treatment and follow-up conformed fully to protocol, the proportion of treatment successes (clinically cured or improved) on Days 12 to 14 was 78.8% (149 of 189) in the tid 10-day group, 86.5% (154 of 178) in the bid 10-day group and 71.1% (140 of 197) in the bid 5-day group. Corresponding values on Days 32 to 38 were 64.2% (95 of 148) in the tid 10-day group, 63.1% (94 of 149) in the bid 10-day group and 57.8% (93 of 161) in the bid 5-day group. None of the differences between the tid 10-day regimen and either of the 2 bid regimens were statistically significant, but the bid 10-day regimen was significantly more effective than the bid 5-day regimen in younger subjects. In the study population as a whole, results were similar to those in per protocol subjects. Overall the incidence of protocol-defined diarrhea was 26.7% (74 of 277) in the tid 10-day group, compared with 9.6% (27 of 280) in the bid 10-day group (P < 0.0001) and 8.7% (25 of 286) in the bid 5-day group (P < 0.0001).. In comparison with the original formulation of Augmentin administered tid for 10 days in the treatment of AOM in children, the new formulation administered bid for 10 days provides at least equivalent efficacy and causes substantially less diarrhea. Administration for 5 days appears not to provide equivalent efficacy, but the difference appears limited to younger children and the margin of difference is small.

Topics: Acute Disease; Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Chemistry, Pharmaceutical; Child; Child, Preschool; Clavulanic Acids; Diarrhea; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Incidence; Infant; Logistic Models; Male; Otitis Media; Treatment Outcome

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

Two hundred and fifteen children aged 4 months 6 years with acute otitis media (AOM) were randomized to be treated either by a single i.m. injection of ceftriaxone, 50 mg/kg, with a second dose in the event of unsatisfactory response after 48 h or a history of recurrent AOM (109 patients) or amoxicillin clavulanate 12.5 mg tid (106 patients). The failure rate was similar in children treated by ceftriaxone and amoxicillin clavulanate, 4.6% and 4.7%, respectively (standard error for intergroup difference -2.87%, 95% confidence interval -5.62% to 5.87%). No significant differences between the groups were found in the dynamics of the resolution of the acute symptomatology, otoscopy findings, relapse rate at 30 days or tympanographic evidence of middle ear effusion at the scheduled visits on days 30, 60 and 90. Recurrence of AOM between days 31 and 90 was observed significantly in more children treated with amoxicillin clavulanate than with ceftriaxone--25 out of 84 (29.4%) versus 11 out of 81 (13.6%) (P = 0.012).. Ceftriaxone injection(s) is as efficient at least as 10-day oral amoxicillin clavulanate for treatment of acute otitis media in children. Although not recommended as routine, ceftriaxone can be considered in the management of acute otitis media under special circumstances, particularly in cases when the ability to tolerate or absorb oral drugs is compromised, in children refusing or unable to take oral therapy or when the compliance is questionable.

Topics: Acute Disease; Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Ceftriaxone; Cephalosporins; Child; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Injections, Intramuscular; Male; Otitis Media; Statistics, Nonparametric

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

This randomized, open label study compared the efficacy and safety of a 5-day course of once daily azithromycin to those of a 10-day course of three times daily amoxicillin/ clavulanate.. One hundred sixty-nine children with confirmed acute bacterial otitis media were randomized to treatment with 10 mg/kg of azithromycin oral suspension on Day 1, followed by 5 mg/kg once daily for the next 4 days or 40 mg/kg/ day of amoxicillin/clavulanate suspension in three divided doses for 10 days. Clinical efficacy and safety were evaluated on Days 11 and 30.. Analysis of evaluable patients 11 days after the start of treatment demonstrated that 87.8% of patients treated with azithromycin and 100.0% of the patients treated with amoxicillin/ clavulanate were cured or improved. Presumed bacteriologic eradication of the baseline pathogens Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes was comparable in the two groups: 87.8% in patients treated with azithromycin; and 100.0% in patients receiving amoxicillin/clavulanate. At Day 30, 82.2% of patients treated with azithromycin and 80.0% of patients treated with amoxicillin/clavulanate were cured or improved. Presumed bacteriologic eradication of the base-line pathogens was similar in the two groups: 82.2% in patients treated with azithromycin; and 81.1% in patients receiving amoxicillin/clavulanate. Relapses occurred in 5.1% of patients receiving azithromycin and 21.1% of patients taking amoxicillin/clavulanate (P = 0.047). Treatment-related side effects occurred in 3.5% of the azithromycin patients compared with 31.0% of amoxicillin/clavulanate patients (P < 0.001).. Azithromycin was comparable to amoxicillin/clavulanate in achieving clinical cure or improvement and presumed eradication of baseline pathogens in pediatric patients with acute otitis media. Azithromycin was significantly better tolerated and was associated with fewer relapses than seen after amoxicillin/clavulanate therapy.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Otitis Media

To compare the efficacy and safety of azithromycin and amoxicillin/clavulanate in pediatric acute otitis media.. Investigators from 12 US centers recruited 677 children. In a randomized, double blind, double dummy fashion, participants received either azithromycin suspension (n = 341) once daily for 5 days or amoxicillin/clavulanate suspension (n = 336) in three divided doses daily for 10 days.. Among evaluable patients satisfactory clinical response rates (cured and improved) measured 11 days after therapy began were 87.5% in the azithromycin group and 87.9% in the amoxicillin/clavulanate group; corresponding rates at 30 days were 73.5% in the azithromycin and 71.2% in the amoxicillin/clavulanate groups. Relapse rates were comparable for the treatment groups. Treatment-related side effects, primarily gastrointestinal, were reported significantly less frequently with azithromycin (8.8%) than with amoxicillin/clavulanate (30.8%) (P < 0.0001). Two (0.6%) azithromycin patients and 12 (3.6%) amoxicillin/ clavulanate patients discontinued therapy because of treatment-related side effects (P < 0.006 between groups).. In these children with acute otitis media, azithromycin given once daily for 5 days and amoxicillin/clavulanate given three times daily for 10 days had similar efficacy; however, azithromycin was significantly better tolerated.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Clavulanic Acids; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Humans; Infant; Otitis Media

This multicenter, randomized, open label study compared the efficacy and safety of azithromycin and amoxicillin/clavulanate for the treatment of acute otitis media among children who were attending a day-care facility or school.. Eligible children with acute otitis media from 21 US centers were randomized to treatment with 10 mg/kg of azithromycin oral suspension on Day 1, followed by 5 mg/kg once daily for the next 4 days or approximately 40 mg/kg/day of amoxicillin/clavulanate suspension in 3 divided doses for 10 days. Clinical efficacy was evaluated on Days 14, 30 and 45. Acceptance and convenience of the medications were assessed on Day 14 by parent interviews with a standardized questionnaire.. Of the 263 children enrolled in the study, 233 were evaluable at the primary evaluation 45 days after the start of treatment. Satisfactory clinical response rates (cure, delayed cure and improvement) were 60.5% in patients treated with azithromycin and 64.9% in patients treated with amoxicillin/clavulanate. Satisfactory clinical response rates at secondary evaluations were also comparable: 92.2% vs. 90.0% at Day 14 and 66.7% vs. 72.7% at Day 30 in patients treated with azithromycin and amoxicillin/clavulanate, respectively. No significant differences in treatment failures, relapses or recurrences were noted with either medication. Azithromycin was significantly better tolerated and caused fewer treatment-related adverse events (7.2%) than amoxicillin/clavulanate (17.1%) (P < 0.001). In response to the interview and questionnaire, parents of children treated with azithromycin noted less need for special arrangements to give medication (2.0% vs. 14.9%). Children liked the taste of azithromycin (89.2%) and did not have to be forced to take the medication (2.4%). Parents of children receiving amoxicillin/clavulanate noted that 61.8% liked the medication and 19.4% of children had to be forced to take it.. This study demonstrates that azithromycin was comparable to amoxicillin/clavulanate in achieving satisfactory clinical response rates in children with acute otitis media attending day care or school. Azithromycin was significantly better tolerated than amoxicillin/ clavulanate. Parents considered azithromycin to be significantly more convenient to administer and more acceptable to children.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Child Day Care Centers; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Schools

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

We performed a randomized, double-blind, placebo-controlled study to determine whether acute otitis media could be prevented by antibiotic therapy initiated promptly after the appearance of symptoms of upper respiratory tract infection. One hundred four children aged 1 to 4 years received a 7-day course of either amoxicillin-clavulanate or placebo. Acute otitis media developed in 9 (18%) of the 50 children receiving amoxicillin clavulanate and in 12 (22%) of the 54 children receiving placebo (p = 0.59).

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Chi-Square Distribution; Child, Preschool; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Otitis Media; Respiratory Tract Infections; Statistics, Nonparametric; Time Factors

We conducted a large, multicenter, randomized, open-label study throughout France comparing the efficacy and safety of cefixime suspension (8 mg/kg/day, b.i.d., for 10 days) versus amoxicillin-clavulanate suspension (80 mg/kg/day, t.i.d., for 10 days) in 510 children (ages 6 to 36 months) with acute otitis media. The most frequent microorganisms colonizing the nasopharynx at the start of treatment were Streptococcus pneumoniae (51.5%), Haemophilus influenzae (45%) and Moraxella catarrhalis (30.2%). Rates of beta-lactamase positivity were 32.1% and 95.3% for H. influenzae and M. catarrhalis, respectively. Decreased susceptibility of S. pneumoniae to penicillin was found in 39.7% of isolates. Clinical efficacy was 87.8% (223/254) for cefixime and 87.0% (215/247) for amoxicillin-clavulanate. At the 5-week follow-up visit, relapse had occurred in 15.7% (31/197) of cefixime-treated patients and in 15.6% (32/205) of those treated with amoxicillin-clavulanate. We conclude that these two regimens are equally effective in acute otitis media in children.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteria; Cefixime; Cefotaxime; Cephalosporins; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Humans; Infant; Nasopharynx; Otitis Media

An open multicentre study was conducted in 484 children between the ages of 6 months and 12 years with otitis media to compare the efficacy, the safety and the tolerance of once-daily azithromycin given for three days versus thrice-daily amoxicillin/clavulanic acid (CA) given for ten days. A satisfactory response (cure plus improvement) was noted 10 to 14 days after the start of treatment in 199 of 215 (92.6%) azithromycin-treated children and in 186 of 198 (93.9%) amoxicillin/CA-treated children. The relationship between treatment and clinical response was independent of chronicity of infection and the presence or absence of a perforated eardrum. Improvement in signs and symptoms of otitis media occurred significantly more rapidly in the children treated with azithromycin. Treatment-related or possibly treatment-related adverse events were recorded in 11 of 243 (4.5%) azithromycin-treated patients and in 20 of 240 (8.3%) treated with amoxicillin/CA. No patients in the azithromycin treatment group were withdrawn from treatment, but six amoxicillin/CA patients, including two < 2 years of age, discontinued treatment prematurely because of adverse events; the difference between treatment groups was statistically significant (p = 0.0146). It is concluded that azithromycin given as an oral suspension once daily for three days is as safe and effective as amoxicillin/CA given thrice daily for ten days in the treatment of children with otitis media.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Analysis of Variance; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; 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

Cefprozil was evaluated in the treatment of acute otitis media with effusion in three open, randomized, multicenter comparative clinical trials. In two trials, 891 pediatric patients were enrolled to either cefprozil or amoxicillin-clavulanate dosage regimens. The treatment groups were comparable in demographic characteristics, and presented with otalgia, middle-ear effusion, or inflamed or bulging tympanic membrane on otoscopic examination. In all patients, tympanocentesis and a culture were required. Two cefprozil oral doses were evaluated, 30 mg/kg/day and 40 mg/kg/day divided into two equal doses (b.i.d.). Amoxicillin-clavulanate was administered at 40 mg/kg/day in three divided doses (t.i.d.). The recommended duration of therapy was ten days. The predominant bacteria isolated were Haemophilus influenzae and Moraxella catarrhalis. The overall satisfactory clinical response rates were similar for cefprozil (83%) and amoxicillin-clavulanate (81%). The bacteriological response rates did not differ significantly, at 84% and 82%. Cefprozil eradicated the most common pathogen, Streptococcus pneumoniae, more often at 91%, vs. 84% for amoxicillin-clavulanate. The eradication rates were similar against Haemophilus influenzae and Moraxella catarrhalis. The patients treated with cefprozil had a lower rate of adverse clinical events (11%) compared to those with amoxicillin-clavulanate (20%). More gastrointestinal adverse experiences, including diarrhea, were reported in the amoxicillin-clavulanate-treated patients. In Study 3, cefprozil 30 mg/kg/day (b.i.d.) was compared to cefaclor 40 mg/kg/day (t.i.d.) and cefixime 8 mg/kg/day (q.d) in the treatment of acute otitis media in 388 pediatric patients. The patients were treated for 10 days, with a follow-up of 18 days. The overall clinical cure rates were 85%, 89% and 85%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cefaclor; Cefixime; Cefotaxime; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Multicenter Studies as Topic; Otitis Media; Randomized Controlled Trials as Topic

Cefprozil is a new oral cephalosporin with activity against the most common pathogens isolated in acute otitis media. This randomized study enrolled 361 patients (mean age 29 months). Physical examination and culture via tympanocentesis were required less than 48 h before therapy. One hundred and ninety-one patients were evaluable for clinical efficacy; 99 received cefprozil (20 mg/kg/day bd) and 92 received amoxycillin/clavulanate (13.3 mg/kg/day tid). Duration of treatment was 7-9 days for 81 patients, 10 days for 105 patients and 11-16 days for five patients. The treatment groups were comparable with respect to demographics, severity of infection and number of previous episodes. Clinical evaluations of efficacy were based on physical examination including otoscopy within a 14 day period after therapy. Satisfactory clinical responses were achieved in 84% of cefprozil-treated patients and 87% of amoxycillin/clavulanate-treated patients. Pathogens most commonly isolated included Haemophilus influenzae (33%) and Streptococcus pneumoniae (22%). All 361 patients were evaluable for safety. Adverse clinical events were reported in 13% (24) of cefprozil-treated patients and 20% (36) of amoxycillin/clavulanate-treated patients. Cefprozil, administered twice a day, is comparable to a regimen of amoxycillin/clavulanate three times a day in the treatment of acute otitis media in children.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefprozil; Cephalosporins; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Male; Moraxella catarrhalis; Neisseriaceae Infections; Otitis Media; Pneumococcal Infections; Streptococcus pneumoniae

The presence of otitis media with effusion (OME) and high negative pressure (-200 to -400 mm H2O), were investigated in the follow-up of a randomized double-blind placebo-controlled trial on the efficacy of amoxicillin/clavulanic acid in the treatment of acute otitis media. All children in this study were recruited from a general practice population. Tympanometry results 1 month from the start of an episode of acute otitis media were taken as outcome criteria. Bilateral middle ear dysfunction was defined as bilateral OME, unilateral OME and contralateral or bilateral high negative pressure. Bilateral middle ear dysfunction was present in 47.9% of the patients. Of all the investigated factors of possible influence (age, sex, season, laterality of acute otitis media, therapy, and clinical course of acute otitis media), only season showed a statistically significant influence on the persistence of OME/high negative pressure (P = 0.001). Bilateral middle ear dysfunction was shown to be of prognostic value for the risk of a recurrence of acute otitis media (odds ratio 3.75).

Topics: Acoustic Impedance Tests; Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Ear, Middle; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media; Otitis Media with Effusion; Placebos; Recurrence; Risk Factors

Brodimoprim is a long acting broad spectrum antibacterial agent. It is a new selective inhibitor of bacterial dihydrofolate reductase, structurally related to trimethoprim. The aim of the present study was to investigate the efficacy and tolerability of brodimoprim (10 mg/kg on the first day, 5 mg/kg/die onward) in the treatment of upper respiratory tract infections in children (age range: 2-14 years). This open group comparative study was performed either in 68 children affected by bacterial pharyngotonsillitis (37 treated with brodimoprim, 31 with erythromycin 560 mg/kg/8 hours) or in 50 patients affected by otitis media (25 treated with brodimoprim, 25 with amoxicillin/clavulanic acid 50 mg/kg/12 hours) or in 52 patients affected by acute sinusitis (25 treated with brodimoprim, 27 with amoxicillin/clavulanic acid 50 mg/kg/12 hours). All patients were clinically evaluated before admission, during the trial and 48 hours after the last dose of antibiotic. At the same time blood and secretion samples were collected for hematology/biochemistry and microbiological assays. A total of 170 subjects were treated and 141 patients demonstrated a clinical recovery/improvement following the treatment period, with approximately the same recovery rate (83%) among the groups. The bacteriological response was evaluated in 169 subjects. Eradication of pathogens was documented in 27 subjects treated with brodimoprim and 28 with erythromycin in the pharyngotonsillitis group, in 22 subjects treated with brodimoprim and 16 with amoxicillin/clavulanic acid in the otitis group and in 17 subjects treated with brodimoprim and 20 with amoxicillin/clavulanic acid in the sinusitis group. The overall eradication in brodimoprim treated patients was 77% in comparison with 76% of eradication obtained in the control groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Erythromycin; Humans; Otitis Media; Pharyngitis; Respiratory Tract Infections; Sinusitis; Tonsillitis; Trimethoprim

A total of 311 children who had recurrent otitis media or who had experienced failure of initial treatment of acute otitis media with phenoxymethylpenicillin, amoxicillin, ampicillin esters or cefaclor were entered into a single-blind study in two parallel groups in order to compare the clinical efficacy and safety of amoxicillin/clavulanate suspension given b.i.d. or t.i.d. for seven days. The patients were examined prior to the start of treatment, at an early follow-up visit 9 to 12 days after the start of treatment and at a late follow-up visit about three weeks later. Specimens for bacteriological culture were taken from the nasopharynx at entry, at the early follow-up visit, and at the late follow-up visit if there were symptoms of otitis. Both treatment groups showed a similar response, 90% or more of the patients being cured or showing improvement at the time of the early follow-up visit. The initial nasopharyngeal cultures showed growth of Haemophilus influenzae in 53% of the patients, Moraxella catarrhalis in 43% and Streptococcus pneumoniae in 39%. After treatment, cultures showed elimination of the initial pathogens in 30% of patients in both groups and recolonization in 23% in both groups. Haemophilus influenzae was the bacteria most frequently found in the nasopharynx at the first follow-up visit. Adverse effects, which consisted mostly of gastrointestinal and dermatological reactions, tended to be more common in the b.i.d. group but the difference was not statistically significant.

Topics: Acute Disease; Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Chi-Square Distribution; Child; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Follow-Up Studies; Haemophilus influenzae; Humans; Infant; Male; Moraxella catarrhalis; Nasopharynx; Otitis Media; Patient Compliance; Recurrence; Single-Blind Method; Streptococcus pneumoniae

An open randomized trial was conducted in 159 children (aged 1 to 8 years) with acute otitis media to compare the clinical efficacy of azithromycin (n = 105) and co-amoxiclav (n = 54). Azithromycin (10 mg/kg/day) was administered as a single dose for three days and co-amoxiclav was given tid for ten days at a dosage according to the manufacturer's instructions for the country. Of 103 evaluable azithromycin patients on day 3 to 5 after the start of therapy, 31 (30%) were considered cured, 67 (65%) improved and five (5%) failed compared with eight (15%) cured, 45 (83%) improved and one (2%) failed among the 54 evaluable co-amoxiclav treated patients. There was a higher number of azithromycin patients with complete resolution of symptoms at this first visit (P = 0.056). By day 10 to 12, clinical equivalence between the two treatment groups was observed with clinical cure in 86 (88%), improvement in 11 (11%) and failure in one (1%) of the 98 azithromycin patients, and in the 54 patients treated with co-amoxiclav, clinical cure was observed in 45 (83%), and improvement in nine (17%) patients. Both drugs were well tolerated and treatment related side-effects were reported in 8/105 (8%) azithromycin and 2/54 (4%) co-amoxiclav patients. In the azithromycin treatment group, these were predominantly mild to moderate gastrointestinal effects, whilst in the co-amoxiclav treatment group, both reports were of mild erythematous rash. One patient from each treatment group was withdrawn due to side-effects (azithromycin--diarrhoea and vomiting; co-amoxiclav--erythematous pruritic rash).(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Azithromycin; Child; Child, Preschool; Clavulanic Acids; Drug Combinations; Erythromycin; Female; Humans; Infant; Male; Otitis Media

A total of 389 children (age 0.6-10.2 years) with typical signs and symptoms of acute otitis media were randomized (1:1) to treatment with either azithromycin or co-amoxiclav. The dosage schedule for azithromycin was 10 mg/kg/day, in a single daily dose, administered for three days. Co-amoxiclav was given at a dose of 13.3 mg/kg (amoxycillin equivalent) tid for ten days. Patients were evaluated 4-6 days and 12-16 days after the start of therapy. A satisfactory clinical response was reported for 93.2% of the 192 evaluable azithromycin-treated patients (144 cured, 35 improved), and for 97.3% of the 189 evaluable co-amoxiclav-treated patients (148 cured, 36 improved). Six (3.0%) relapses occurred in the azithromycin group, and four (2.1%) in the co-amoxiclav treatment group, respectively. Side-effects were recorded in a significantly fewer number of the azithromycin patients (23 of 197; 11.7%) compared with the co-amoxiclav patients (43 of 192; 22.4%, P < 0.02). Adverse events were mainly gastrointestinal in nature, with diarrhoea the most frequent complaint (32 cases with co-amoxiclav; five with azithromycin; P < 0.001). One patient from each group discontinued therapy because of treatment-related adverse events. Laboratory analyses (mainly haematological in nature) showed abnormalities in six of 100 azithromycin patients and ten of 101 co-amoxiclav patients. It was concluded that three-day, single-dose azithromycin and ten-day tid co-amoxiclav therapy have comparable clinical efficacy in paediatric patients with acute otitis media; however, there was a lower incidence of side effects in the azithromycin group.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Azithromycin; Child; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Combinations; Erythromycin; Female; Humans; Infant; Male; Otitis Media

We prospectively studied 271 infants and children (2 months to 7 years of age) with acute otitis media (AOM) for viral and bacterial causes, outcome at the end of therapy, and frequency of recurrence within 1 month. Comprehensive virologic methods, including viral antigen detection, cell culture, and serologic studies, were used to diagnose viral infection of the respiratory tract, middle ear, or both. Evidence of viral infection was found in 46% (124/271) of patients with AOM. Sixty-six patients (24%) had virus or viral antigen in the middle ear fluid; 50 of these patients (76%) also had bacteria in middle ear fluid, and 16 (24%) had virus alone. More patients with AOM and combined bacterial and viral infection (51%) had persistent otitis (3 to 12 days after institution of antibiotic treatment), compared with those with only bacterial otitis (35%; p = 0.05) or patients with only viral infection (19%; p less than 0.01). Of patients with only viral infection, 4 of 10 with virus in middle ear fluid had persistent otitis, compared with none of 11 patients who had virus only in nasal wash specimens or whose viral infection was diagnosed only by serologic studies. Our data suggest that viruses interact with bacteria and that concurrent viral infection can significantly worsen the clinical course of bacterial AOM. The presence of virus in middle ear fluid may contribute to the pathogenesis and outcome of bacterial AOM. The mechanism of these interactions deserve further investigation.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cefpodoxime; Ceftizoxime; Clarithromycin; Clavulanic Acids; Drug Therapy, Combination; Erythromycin; Female; Humans; Infant; Male; Otitis Media; Respiratory Tract Infections; Treatment Outcome; Virus Diseases

A multicenter study of the new pediatric formulation of Augmentin (containing 100 mg amoxicillin and 12.5 mg clavulanic acid per ml) in acute otitis media (AOM) in patients aged three months to three years was carried out by hospital-based pediatricians. Study patients seen at the hospital outpatient clinics were given the drug in a daily dosage of 80 mg in three (83% of cases) or four (15%) divided doses for 6 to 10 days; 28% of patients were also given an antiinflammatory agent. A total of 83 patients with a mean age of 13.5 months were included (89% of patients were less than two years of age); one-third of these patients were included after failure of another antimicrobial agent (macrolide 46%, cephalosporin 23%). The AOM was bilateral in most patients (69.5%) and 46% of patients had a history of previous AOM. Temperature was elevated in 85% of cases and more than half the patients had gastrointestinal symptoms (vomiting, diarrhea) prior to initiation of the study drug. At the interim evaluation on the fourth treatment day, tympanic membranes were normal in 43.5% of cases and improved in 22% of cases. Over 92% of patients achieved resolution of their AOM by the end of the treatment period, regardless of whether or not myringostomy had been performed on Do. Among the 27 patients given the study drug as rescue therapy after failure of another antimicrobial, 24 (89%) recovered fully.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Chemistry, Pharmaceutical; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Hospitals, Pediatric; Humans; Infant; Male; Otitis Media; Treatment Outcome

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Denmark; Double-Blind Method; Drug Therapy, Combination; Humans; Infant; Otitis Media; Patient Compliance; Penicillin V

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

To determine the efficacy of coamoxiclav in children aged 6 months to 12 years with recurrent acute otitis media.. A randomised double blind placebo controlled clinical trial.. General practice in the Netherlands.. 121 children with recurrent acute otitis media, defined by onset of otalgia and otoscopic signs of middle ear infection within four to 52 weeks after the previous attack. Confirmation of diagnosis and randomisation was done by otolaryngologists.. Oral co-amoxiclav or placebo in weight related doses for seven days.. An irregular clinical course defined as the presence of otalgia or a body temperature greater than or equal to 38 degrees C, or both, after three days.. Eleven (16%; 95% confidence interval 9% to 28%) children had an irregular course in the co-amoxiclav group and 10 (19%; 9% to 31%) in the placebo group (difference not significant). Age, dichotomised at 2 years, was the only significant prognostic factor for irregular course of the disease (odds ratio 5.9; 1.8 to 19.1). Among children aged below 2 years, 28% (4/14) in the co-amoxiclav group and 58% (7/12) in the placebo group had irregular courses. For children 2 years and older these percentages were 13% (7/52) and 7% (3/41).. Children with recurrent acute otitis media are at greater risk of an irregular clinical course of the disease than children with a first episode of acute otitis media. Co-amoxiclav has no significant benefit over placebo in treating children over 2 years with acute otitis media.

Topics: Acute Disease; Age Factors; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Prognosis; Recurrence

One hundred five infants and children with acute otitis media were randomized to therapy with loracarbef, an experimental carbacephem antibiotic, or amoxicillin-clavulanate (Augmentin), an approved drug for this disease. Ninety-two were evaluable (46 in each group). Middle ear fluid samples obtained for culture before therapy grew Haemophilus spp. in 30% of cases, pneumococci in 29% of cases, and Moraxella catarrhalis in 15% of cases. beta-Lactamase-producing bacteria were found in 37% of patients. Clinical failure occurred in four loracarbef-treated patients and one amoxicillin-clavulanate-treated patient (P = 0.361). Recurrence of acute otitis media was more common in the 2 to 3 weeks after loracarbef treatment (eight patients) than it was after amoxicillin-clavulanate therapy (three patients), but not significantly so (P = 0.197). Thus, combined failure and recurrence occurred in 12 loracarbef-treated patients and four amoxicillin-clavulanate-treated patients (P = 0.052). Gastrointestinal side effects occurred in 13 loracarbef-treated and 21 amoxicillin-clavulanate-treated patients (P = 0.13). Diaper rash was more common with amoxicillin-clavulanate (22 patients) than with loracarbef (10 patients; P = 0.016). Satisfactory results were achieved with both antibiotics, and adverse effects, although common, were minor.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteria; Cephalosporins; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Infant; Male; Microbial Sensitivity Tests; Otitis Media; Random Allocation; Recurrence

A total of 102 children with recurrent otitis media or therapeutic failure after treatment with phenoxymethyl penicillin were entered into a double-blind study with parallel groups, comparing treatment with amoxycillin/clavulanate suspension (Spektramox) for 7 days with amoxycillin suspension (Imacillin) for 10 days. Bacterial and clinical investigations were performed. A total of 91 patients were evaluated for efficacy at the first follow-up visit (10-12 days after start of treatment). Amoxycillin/clavulanate and amoxycillin showed equally high, satisfactory treatment results, i.e. more than a 90% response. Similarly, there was no statistically significant difference between the treatment groups at the second follow-up visit (about 30 days after start of treatment). Bacteriological cultures from the nasopharynx showed equal distribution of Haemophilus influenzae, Branhamella catarrhalis and Streptococcus pneumoniae between the study groups. Elimination of the initially occurring pathogens was equal in the two study groups with the exception of B. catarrhalis which was eliminated to a significantly higher extent with amoxycillin/clavulanate. Both drugs were well tolerated. In patients with recurrent otitis media or therapeutic failure, treatment with amoxycillin/clavulanate for 7 days results in high, satisfactory clinical effects and is comparable to treatment with amoxycillin for 10 days.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child, Preschool; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Female; Haemophilus Infections; Humans; Male; Moraxella catarrhalis; Otitis Media; Penicillin V; Pneumococcal Infections; Time Factors

In a prospective randomized open study, 111 young children with otitis media were orally treated during 10 days with Pediazole (50 mg/kg/day in 3 divided doses) or amoxicillin + clavulanic acid (40 mg/kg/day in 3 or 4 divided doses) for efficacy and safety evaluation. 51 children wer assigned to amoxicillin + clavulanic acid (group I) and 60 to erythromycin-sulfisoxazole (group II). Mean age was respectively 24.7 months in group I and 23.4 months in group II. Results of efficacy evaluation were as follows: (table; see text) there was no statistically significant difference between the two treatment groups for efficacy. Overall safety was good. The treatment was discontinued only in four cases (3 in the amoxicillin + clavulanic acid group and 1 in the EES-sulfisoxazole group). In conclusion, Erythromycin sulfisoxazole combination (Pediazole) fits in with current epidemiological profile of Acute Otitis Media and represents a therapy of choice in this indication.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Child, Preschool; Clavulanic Acids; Drug Combinations; Drug Therapy, Combination; Drug Tolerance; Erythromycin; Female; Humans; Infant; Male; Otitis Media; Prospective Studies; Randomized Controlled Trials as Topic; Recurrence; Sulfisoxazole

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

Twice-daily trimethoprim-sulfamethoxazole has been shown to be effective in the treatment of acute otitis media except that caused by group A beta-streptococci. Amoxicillin-clavulanate potassium is effective in vitro against all bacterial pathogens causing acute otitis media and has been reported to be effective when given twice daily for urinary tract infections, acute otitis media and respiratory tract infections. To determine whether the in-vitro efficacy of amoxicillin-clavulanate carries over clinically, we conducted a prospective randomized double-blind trial in 219 children presenting at a pediatric walk-in clinic. Diagnosis and follow-up assessments were made by means of examination of the tympanic membrane and acoustic otoscopy. Of the 219 children 202 (101 in either group) were assessed by a specially trained nurse at a follow-up visit 12 to 16 (mean 14) days after treatment was begun. Cure was defined as absence of symptoms and normal results of both visual inspection of the tympanic membrane and acoustic reflectometry; improvement was defined as absence of symptoms and either normal appearance of the tympanic membrane or normal results of acoustic reflectometry; treatment failure was defined as abnormal appearance of the tympanic membrane along with an acoustic reflectometry reading of 5 units or more. There were no differences in age (mean 60 months), sex or proportion of subjects with unilateral versus bilateral disease between the two groups. The combined rate of cure an improvement was significantly higher with trimethoprim-sulfamethoxazole (93%) than with amoxicillin-clavulanate (82%) (p = 0.03). The rate of compliance (more than 80% of the drug taken) did not differ significantly between the two groups. Gastrointestinal side effects were more common with amoxicillin-clavulanate (p less than 0.0001). Our results suggest that for acute otitis media twice-daily trimethoprim-sulfamethoxazole is more effective clinically and produces fewer side effects than twice-daily amoxicillin-clavulanate.

Topics: Acoustic Impedance Tests; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Diarrhea; Double-Blind Method; Drug Administration Schedule; Drug Evaluation; Drug Therapy, Combination; Follow-Up Studies; Humans; Infant; Otitis Media; Patient Compliance; Prospective Studies; Randomized Controlled Trials as Topic; Trimethoprim, Sulfamethoxazole Drug Combination

In a multicenter study, Augmentin pediatric suspension was given to 1,227 young children (3 months - 3 years) with otitis media seen in private practice. Patterns of otitis included first episodes, recurrences, and forms that had failed to respond to previous antimicrobial therapy. The study medication was given as a first-line treatment, on the basis of epidemiologic data, in a daily dose of 40 mg/kg for 7 to 10 days. In the 3 months to 3 years age group, two micro-organisms are prevalent, ie. Haemophilus influenzae, which is the most common agent and may produce beta-lactamases (10 to 18% of strains), and Streptococcus pneumoniae. Among our patients, the otitis-conjunctivitis syndrome caused by Haemophilus influenzae was fairly frequent (8.7% of cases). Clinical effectiveness as evaluated between D8 and D11 was good or very good in 91.2% of cases. Tolerance was satisfactory in 83% of patients. Side effects were uncommon and consisted primarily in gastrointestinal symptoms. We point out the potentially deleterious effect of concurrent anti-inflammatory treatment. Acceptability of the suspension was judged satisfactory by the parents in 91.6% of cases. Augmentin proved well-suited to epidemiologic data, outstandingly effective, well tolerated, and easy to use because of its presentation as a pediatric suspension; it is therefore an appropriate first-line drug in the common indication addressed in our study.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Humans; Infant; Multicenter Studies as Topic; Otitis Media

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefaclor; Cephalexin; Child, Preschool; Clavulanic Acids; Clinical Trials as Topic; Drug Therapy, Combination; Female; Humans; Male; Otitis Media; Random Allocation

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefaclor; Cephalexin; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Male; Otitis Media; Recurrence

One hundred thirty-three infants and children with documented acute otitis media (OM) were randomized to receive the oral suspension of either amoxicillin-clavulanate potassium or cefaclor. Beta-lactamase-producing bacteria were found in 10.9 and 14.5% of subjects treated with amoxicillin-clavulanate potassium and cefaclor, respectively. Subjects were reexamined at 5, 10, 30, 60 and 90 days after the initiation of therapy and whenever signs/symptoms of acute otitis media recurred. All but two children had resolution of otalgia/otorrhea during the initial treatment period. The drug groups were not significantly different in the percentage of evaluable subjects with otitis media with effusion at each scheduled follow-up visit. Recurrence of acute OM/otorrhea [corrected] developed in a similar percentage of subjects in both treatment categories. Both subjects with and those without middle ear effusion at 10 days had approximately a 50% recurrence rate of subsequent middle ear disease. Adverse side effects/complaints, which occurred in significantly more children treated with amoxicillin-clavulanate potassium, were generally mild and primarily gastrointestinal.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefaclor; Cephalexin; Child; Child, Preschool; Clavulanic Acids; Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Earache; Female; Fever; Humans; Infant; Male; Otitis Media; Otitis Media with Effusion; Random Allocation; Recurrence

A total of 150 children with acute otitis media were randomly allocated to treatment with amoxicillin-potassium clavulanate (Augmentin) or with cefaclor. Each drug was given in a daily dosage of approximately 40 mg/kg in three divided doses for ten days. Tympanocentesis done before treatment yielded specimens that contained pneumococcus or Haemophilus sp or both in 67% of specimens. Viridans group streptococci were isolated from 10% of specimens and Branhamella catarrhalis from 6%. Patients were scheduled for follow-up examinations at midtreatment, end of therapy, and at 30, 60, and 90 days. Of the 150 children, 130 were evaluable. Five of 60 patients (8%) treated with cefaclor were considered therapeutic failures because of persistent purulent drainage and isolation of the original pathogen or suprainfection. There were no failures among patients treated with Augmentin (P = .019). Rates of relapse, recurrent acute otitis media with effusion, and persistent middle ear effusion were comparable in the two groups of patients. Diaper rash, or loose stools, or both were significantly more common in children treated with Augmentin (34%) than in those taking cefaclor (12%), but in no case was it necessary to discontinue medication because of these mild side effects (P = .002). Cefaclor therapy was discontinued in one patient because of severe abdominal pain and vomiting. In this study, treatment with Augmentin was superior to treatment with cefaclor in the acute phase of acute otitis media with effusion, but Augmentin produced more adverse effects. The rates of persistent middle ear effusion and recurrent acute otitis media with effusion were comparable with the two regimens.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefaclor; Cephalexin; Child; Child, Preschool; Clavulanic Acids; Drug Combinations; Female; Follow-Up Studies; Haemophilus Infections; Humans; Infant; Male; Otitis Media; Otitis Media with Effusion; Pneumococcal Infections; Random Allocation

Acute otitis media (AOM) is a common indication for antibiotics in children. We sought to characterize the frequency of nonguideline concordant antibiotic therapy for AOM in the United States, by agent and duration.. Using national administrative claims data (2016-2019), we identified children aged 6 months to 17 years with an oral antibiotic dispensed within 3 days of a new diagnosis of suppurative AOM. Use of nonguideline concordant agents and durations, defined based on national treatment guidelines, were summarized by age, race, rurality, region, and insurance type. Subsequent oral antibiotic dispensing within the year after AOM diagnosis was also evaluated. We created sunburst diagrams to visualize longitudinal patterns of within-person antibiotic utilization for AOM, by agent and duration.. We identified 789 424 eligible commercially-insured and 502 239 medicaid-insured children. Among commercially insured children, 35% received nonguideline concordant agents for AOM, including cefdinir (16%), amoxicillin-clavulanate (12%), and azithromycin (7%). Fewer children age <2 years received a nonguideline concordant initial agent (27%) compared to age ≥6 years (41%). More children age <2 years received three or more antibiotics over the following year (34% vs. 3% for children age ≥6 years). The most common treatment duration was 10 days for all ages; treatment duration for the initial antibiotic was nonguideline concordant for 95% and 89% of children age 2-5 years and ≥6 years, respectively. Patterns were similar for medicaid-insured children.. Nonguideline concordant antibiotic use is common when treating AOM in children, including use of broad-spectrum agents and longer-than-recommended antibiotic durations.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefdinir; Child; Humans; Infant; Otitis Media; United States

The objective of the study was to compare the antibiotic treatment failure and recurrence rates between antibiotic agents (amoxicillin, amoxicillin-clavulanate, cefdinir, and azithromycin) for children with uncomplicated acute otitis media (AOM).. We completed a retrospective cohort study of children 6 months-12 years of age with uncomplicated AOM identified in a nationwide claims database. The primary exposure was the antibiotic agent, and the primary outcomes were treatment failure and recurrence. Logistic regression was used to estimate ORs, and analyses were stratified by primary exposure, patient age, and antibiotic duration.. Among the 1 051 007 children included in the analysis, 56.6% were prescribed amoxicillin, 13.5% were prescribed amoxicillin-clavulanate, 20.6% were prescribed cefdinir, and 9.3% were prescribed azithromycin. Most prescriptions (93%) were for 10 days, and 98% were filled within 1 day of the medical encounter. Treatment failure and recurrence occurred in 2.2% (95% CI: 2.1, 2.2) and 3.3% (3.2, 3.3) of children, respectively. Combined failure and recurrence rates were low for all agents including amoxicillin (1.7%; 1.7, 1.8), amoxicillin-clavulanate (11.3%; 11.1, 11.5), cefdinir (10.0%; 9.8, 10.1), and azithromycin (9.8%; 9.6, 10.0).. Despite microbiologic changes in AOM etiology, treatment failure and recurrence were uncommon for all antibiotic agents and were lower for amoxicillin than for other agents. These findings support the continued use of amoxicillin as a first-line agent for AOM when antibiotics are prescribed.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Cefdinir; Child; Humans; Infant; Otitis Media; Retrospective Studies; Treatment Outcome

This study aimed to evaluate antibiotic prescriptions for children with otitis media (OM) in a large nationwide network of private clinics between 2014 and 2020. Special focus was paid to amoxicillin and amoxicillin-clavulanic acid prescriptions, which the national guidelines recommend for first-line drugs. We also focused on macrolides, which are commonly prescribed for respiratory tract infections in children but are not appropriate for OM cases.. The data were obtained from the electronic health records of about 250,000 annual visits in <18 years old children. The collected variables were all diagnoses, age, visit year, doctor's specialty, and prescribed antibiotics. Children with OM and upper respiratory tract infections were included, but those with lower respiratory tract infections were excluded.. The number of children with OM was 357,390 (55.2% boys). Antibiotics were prescribed in 44.8% of cases, with the lowest proportion (44.1%) being in <2 years old children. The overall prescription rate decreased from 48.3% in 2014 to 41.4% in 2020. The rates were 19.3% and 18.1% for amoxicillin and 12.6% and 13.2% for amoxicillin-clavulanic acid, respectively. Macrolide prescriptions were reduced from 7.5% to 3.5%. Pediatricians prescribed antibiotics for 38.8%, general practitioners for 54.0% and ear, nose and throat physicians for 39.8% of children with OM.. The selection of antibiotics for OM, when prescribed, was according to the recommendations (amoxicillin or amoxicillin-clavulanic acid) in 80.1% of pediatricians, 67.0% of general practitioners and 55.1% of ear, nose and throat physicians.

Topics: Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Drug Utilization; Female; Humans; Macrolides; Male; Otitis Media; Outpatients; Practice Patterns, Physicians'; Respiratory Tract Infections

Haemophilus influenzae is a prevalent agent of respiratory infections, including acute otitis media (AOM), that lead to high antibiotic prescription and may contribute to the development of bacterial resistance to antibiotics. The objective of this work was to describe and analyse antibiotic resistance of H. influenzae from 2017 to 2021 in France.. We characterized H. influenzae isolates transmitted to the French national reference centre for H. influenzae between 2017 and 2021. We included all the 608 non-invasive respiratory isolates. Resistance rates to the main antibiotics were described. The relationship between resistance rate, age, and sex of patients and germ serotype was investigated.. Isolates were mainly from alveolar lavage (29.3%), expectoration (22.9%), or sputum (15%). Resistance to amoxicillin (61.4%), amoxicillin/clavulanic acid (47.4%), and cefotaxime (39.3%) was high and correlated with the presence of β-lactamase and/or modifications of the ftsI gene encoding penicillin-binding protein 3. Resistance to sulfamethoxazole/trimethoprim (33.2%) was more moderate. There were no significant differences according to serotype, age, or gender.. The benefit/risk balance of first choice use of amoxicillin and even of amoxicillin/clavulanic acid in AOM is questionable in view of the significant resistance to H. influenzae. The use of sulfamethoxazole/trimethoprim could be an alternative but may still need further evaluation.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Drug Resistance, Microbial; Haemophilus influenzae; Humans; Microbial Sensitivity Tests; Otitis Media; Sulfamethoxazole; Trimethoprim

The Korean Otologic Society developed guidelines for treatment of acute otitis media (AOM) in 2010, which advocated limiting the prescription of antibiotics. However, it is not known whether this has influenced the antibiotic prescription rate. Thus, this study aimed to examine the impact of these guidelines on the patterns in antibiotic prescription for AOM in Korean children.. AOM patients aged less than 15 years, included in the Korean Health Insurance Review and Assessment Service database from 2009 to 2017, were retrospectively identified. We estimated the overall antibiotic prescription rate, antibiotic prescription rates for suppurative and non-suppurative AOM, and types of antibiotics prescribed. Moreover, we analyzed differences in antibiotic prescription rates according to age group, hospital type, and medical department.. The overall antibiotic prescription rate decreased significantly from 2009 to 2017. The antibiotic prescription rate for non-suppurative AOM decreased much more than the rate for suppurative AOM. Overall, amoxicillin/clavulanate was the most commonly prescribed antibiotic, followed by cephalosporin. The antibiotic prescription rate decreased by a similar margin in all age groups. Tertiary referral hospitals and otorhinolaryngology department showed the lowest antibiotic prescription rate every year.. This study demonstrated the changes in antibiotic prescription rates for AOM following implementation of the Korean AOM treatment guidelines. The practice of antibiotic prescription for children with AOM appears to have decreased every year. However, the overall antibiotic prescription rate is still high. Therefore, clinicians should understand and adhere to the guidelines, and merely observe children with mild AOM symptoms.

Topics: Acute Disease; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Female; Humans; Infant; Male; Otitis Media; Practice Patterns, Physicians'; Republic of Korea; Retrospective Studies

Topics: Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Animals; Anti-Bacterial Agents; Antibodies, Bacterial; Antigens, Bacterial; Biofilms; Chinchilla; Cohort Studies; Ear, Middle; Female; Gastrointestinal Microbiome; Haemophilus Infections; Haemophilus influenzae; Haemophilus Vaccines; Immunization; Male; Otitis Media

Concerns about non-typeable Haemophilus influenzae (NTHi) in otitis media (OM) have grown after the introduction of pneumococcal conjugate vaccine (PCV). We aim to better understand the clinical role of NTHi in pediatric OM.. Middle ear fluid samples from children <18 years with OM were obtained from 2010 to 2015. For culture-positive episodes (Streptococcus pneumoniae, H. influenzae, Moraxella catarrhalis, and Streptococcus pyogenes), patients' demographic and clinical information were reviewed and analyzed.. A total of 783 episodes were included with 31.8% of isolates as positive. S. pneumoniae was recovered in 69.4%, NTHi in 24.6%, M. catarrhalis in 5.6%, and S. pyogenes in 4.0% of culture-positive episodes. The proportion of pneumococcal OM has declined since 2012 (P for trend <0.005), but NTHi OM rose simultaneously (P for trend = 0.009). Factors associated with increased risk of NTHi infection included less spontaneous otorrhea (OR 0.15, 95% CI 0.06-0.39, P < 0.001), absence of fever (OR 0.30, 95% CI 0.14-0.66, P = 0.003), concurrent sinusitis (OR 2.91, 95% CI 1.36-6.20, P = 0.006), previous ventilation tube insertion (OR 12.02, 95% CI 3.15-45.92, P < 0.001) and recurrent OM (OR 3.43, 95% CI 1.01-11.71, P = 0.049). The susceptibility of NTHi to amoxicillin/clavulanate was 82.0%.. NTHi OM has trended upward in the post-PCV era. Concurrent sinusitis, previous ventilation tube insertion, and recurrent OM were associated with NTHi OM implicated a correlation between NTHi and complex OM. In consideration of NTHi infection, we suggest amoxicillin/clavulanate as the first-line therapy for OM among Taiwanese children.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child, Preschool; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Male; Microbial Sensitivity Tests; Moraxella catarrhalis; Otitis Media; Pneumococcal Vaccines; Prospective Studies; Recurrence; Risk Factors; Spain; Streptococcus pneumoniae; Streptococcus pyogenes; Vaccines, Conjugate

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

Septic arthritis of the temporomandibular joint as a complication of acute otitis media is rare in the Western world. This report describes the case of a 7-year-old boy who had pain in his right ear and limited mouth opening, following the onset of acute otitis media. A contrast-enhanced computed tomography scan revealed right-sided mastoiditis and hydrops of the right temporomandibular joint, suggesting septic arthritis. Real-time PCR and microbiologic analysis identified Streptococcus pyogenes and Staphylococcus epidermidis in the joint aspirate. Treatment with arthrocentesis and antibiotics led to full recovery of temporomandibular joint function.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Arthritis, Infectious; Arthrocentesis; Child; Humans; Male; Otitis Media; Radiography, Panoramic; Real-Time Polymerase Chain Reaction; Streptococcus pyogenes; Temporomandibular Joint Disorders; Tomography, X-Ray Computed

Acute respiratory tract infections account for the majority of antibiotic exposure in children, and broad-spectrum antibiotic prescribing for acute respiratory tract infections is increasing. It is not clear whether broad-spectrum treatment is associated with improved outcomes compared with narrow-spectrum treatment.. To compare the effectiveness of broad-spectrum and narrow-spectrum antibiotic treatment for acute respiratory tract infections in children.. A retrospective cohort study assessing clinical outcomes and a prospective cohort study assessing patient-centered outcomes of children between the ages of 6 months and 12 years diagnosed with an acute respiratory tract infection and prescribed an oral antibiotic between January 2015 and April 2016 in a network of 31 pediatric primary care practices in Pennsylvania and New Jersey. Stratified and propensity score-matched analyses to account for confounding by clinician and by patient-level characteristics, respectively, were implemented for both cohorts.. Broad-spectrum antibiotics vs narrow-spectrum antibiotics.. In the retrospective cohort, the primary outcomes were treatment failure and adverse events 14 days after diagnosis. In the prospective cohort, the primary outcomes were quality of life, other patient-centered outcomes, and patient-reported adverse events.. Of 30 159 children in the retrospective cohort (19 179 with acute otitis media; 6746, group A streptococcal pharyngitis; and 4234, acute sinusitis), 4307 (14%) were prescribed broad-spectrum antibiotics including amoxicillin-clavulanate, cephalosporins, and macrolides. Broad-spectrum treatment was not associated with a lower rate of treatment failure (3.4% for broad-spectrum antibiotics vs 3.1% for narrow-spectrum antibiotics; risk difference for full matched analysis, 0.3% [95% CI, -0.4% to 0.9%]). Of 2472 children enrolled in the prospective cohort (1100 with acute otitis media; 705, group A streptococcal pharyngitis; and 667, acute sinusitis), 868 (35%) were prescribed broad-spectrum antibiotics. Broad-spectrum antibiotics were associated with a slightly worse child quality of life (score of 90.2 for broad-spectrum antibiotics vs 91.5 for narrow-spectrum antibiotics; score difference for full matched analysis, -1.4% [95% CI, -2.4% to -0.4%]) but not with other patient-centered outcomes. Broad-spectrum treatment was associated with a higher risk of adverse events documented by the clinician (3.7% for broad-spectrum antibiotics vs 2.7% for narrow-spectrum antibiotics; risk difference for full matched analysis, 1.1% [95% CI, 0.4% to 1.8%]) and reported by the patient (35.6% for broad-spectrum antibiotics vs 25.1% for narrow-spectrum antibiotics; risk difference for full matched analysis, 12.2% [95% CI, 7.3% to 17.2%]).. Among children with acute respiratory tract infections, broad-spectrum antibiotics were not associated with better clinical or patient-centered outcomes compared with narrow-spectrum antibiotics, and were associated with higher rates of adverse events. These data support the use of narrow-spectrum antibiotics for most children with acute respiratory tract infections.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cephalosporins; Child; Child, Preschool; Female; Humans; Macrolides; Male; Otitis Media; Pharyngitis; Primary Health Care; Quality of Life; Respiratory Tract Infections; Retrospective Studies; Sinusitis; Streptococcal Infections; Streptococcus pyogenes; Treatment Failure

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child, Preschool; Drug Combinations; Humans; Infant; Infant, Newborn; Otitis Media

Streptococcus pneumoniaeis one of the key pathogens responsible for otitis media (OM), the most common infection in children and the largest cause of childhood antibiotic prescription. Novel therapeutic strategies that reduce the overall antibiotic consumption due to OM are required because, although widespread pneumococcal conjugate immunization has controlled invasive pneumococcal disease, overall OM incidence has not decreased. Biofilm formation represents an important phenotype contributing to the antibiotic tolerance and persistence ofS. pneumoniaein chronic or recurrent OM. We investigated the treatment of pneumococcal biofilms with nitric oxide (NO), an endogenous signaling molecule and therapeutic agent that has been demonstrated to trigger biofilm dispersal in other bacterial species. We hypothesized that addition of low concentrations of NO to pneumococcal biofilms would improve antibiotic efficacy and that higher concentrations exert direct antibacterial effects. Unlike in many other bacterial species, low concentrations of NO did not result inS. pneumoniaebiofilm dispersal. Instead, treatment of bothin vitrobiofilms andex vivoadenoid tissue samples (a reservoir forS. pneumoniaebiofilms) with low concentrations of NO enhanced pneumococcal killing when combined with amoxicillin-clavulanic acid, an antibiotic commonly used to treat chronic OM. Quantitative proteomic analysis using iTRAQ (isobaric tag for relative and absolute quantitation) identified 13 proteins that were differentially expressed following low-concentration NO treatment, 85% of which function in metabolism or translation. Treatment with low-concentration NO, therefore, appears to modulate pneumococcal metabolism and may represent a novel therapeutic approach to reduce antibiotic tolerance in pneumococcal biofilms.

Topics: Adenoids; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Biofilms; Child; Child, Preschool; Drug Resistance, Bacterial; Drug Synergism; Drug Therapy, Combination; Gene Expression Regulation, Bacterial; Humans; Hydrazines; Nitrates; Nitric Oxide; Nitric Oxide Donors; Nitroprusside; Otitis Media; Pneumococcal Infections; Protein Biosynthesis; Sodium Nitrite; Streptococcus pneumoniae; Transcription, Genetic

Otitis media is a more frequent occurrence in children, and the disease may progress from an acute to chronic state if appropriate and timely intervention is not initiated.. A total of 212 children aged 6 months to 10 years were examined and treated for otitis media, in a 13-month hospital-based study.. Acute otitis media was diagnosed in 130 (61.3 per cent) of the patients. There were 82 (38.7 per cent) chronic suppurative otitis media cases. The incidence of acute otitis media and chronic suppurative otitis media in the first year of life was 54.6 per cent and 45.1 per cent respectively. Chronic suppurative otitis media patients were assigned to one of three treatment groups. Recovery occurred in 70.4 per cent of amoxicillin-treated patients, in 88.9 per cent of amoxicillin-clavulanic acid treated patients and in 96.4 per cent of culture and antibiotic sensitivity test patients. Relapses were seen only in the amoxicillin (five cases) and amoxicillin-clavulanic acid (two cases) groups.. The success rate in patients treated with antibiotics makes this option mandatory for an established diagnosis.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Chronic Disease; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Nigeria; Otitis Media; Otitis Media, Suppurative

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Female; Humans; Male; Microbial Sensitivity Tests; Otitis Media; Otitis Media, Suppurative

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Female; Humans; Male; Microbial Sensitivity Tests; Otitis Media; Otitis Media, Suppurative

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 determined the cost of care for 2 diagnosis and management approaches for acute otitis media (AOM) among children 6 to 30 months old. A case-control design was used. Cases included 208 children diagnosed with AOM based on a bulging tympanic membrane (TM) and treated with amoxicillin/clavulanate. Controls (5:1 ratio) included 1020 children with AOM diagnosed not requiring bulging of the TM and treated with amoxicillin. Fewer cases (49%) than controls (69%) were diagnosed with AOM (P < .001), fewer were diagnosed with recurrent AOM or AOM treatment failure (0.34 vs 1.6/child; P < .0001), and fewer had insertion of tympanostomy tubes (6.3% vs 14.8%) due to recurrent AOM (P < .0001). The combined direct payments and indirect costs for management of AOM were $539/case versus $1,023/control. Using Rochester NY payments generalized to the US birth cohort, this case diagnosis and treatment strategy could save $1.008 billion per year.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Case-Control Studies; Child, Preschool; Cost of Illness; Female; Humans; Infant; Male; Middle Ear Ventilation; Otitis Media; Primary Health Care

Streptococcus pneumoniae (S. pneumoniae) and Haemophilus influenzae (H. influenzae) are considered major causes of bacterial acute otitis media (AOM) worldwide, but data from Asia on primary causes of AOM are limited. This tympanocentesis-based, multi-center, cross-sectional study assessed bacterial etiology and antimicrobial susceptibility of AOM in Thailand.. Children 3 to 59 months presenting with AOM (< 72 hours of onset) who had not received prescribed antibiotics, or subjects who received prescribed antibiotics but remained symptomatic after 48-72 hours (treatment failures), were eligible. Study visits were conducted from April 2008 to August 2009. Bacteria were identified from middle ear fluid collected by tympanocentesis or spontaneous otorrhea swab sampling (< 20% of cases). S. pneumoniae and H. influenzae serotypes were determined and antimicrobial resistance was also assessed.. Of the 123 enrolled children, 112 were included in analysis and 48% of the 118 samples were positive for S. pneumoniae (23% (27/118)), H. influenzae (18% (21/118)), Moraxella catarrhalis (6% (7/118)) or Streptococcus pyogenes (3% (4/118)). The most common pneumococcal serotypes were 19F (26%) and 14 (22%). The majority of H. influenzae isolates were encapsulated (18/21), with 13 type b (Hib) representing 62% of all H. influenzae isolate or 11% of all samples (13/118), and there were only 3 non-typeable isolates. Despite high antibiotic resistance, amoxicillin/clavulanate susceptibility was high. No pneumococcal vaccine use was reported.. S. pneumoniae and H. influenzae, both frequently antibiotic resistant, were leading causes of bacterial AOM and there was an unexpectedly high burden of Hib in this population unvaccinated by any Hib conjugate vaccine. Conjugate vaccines effective against pneumococcus and H. influenzae could potentially reduce the burden of AOM in this population.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Cefotaxime; Child, Preschool; Cross-Sectional Studies; Drug Resistance, Multiple, Bacterial; Female; Haemophilus Infections; Haemophilus influenzae type b; Humans; Infant; Male; Otitis Media; Pneumococcal Infections; Streptococcus pneumoniae; Suction; Thailand

An 8-year-old, male neutered Siamese cat was presented with Horner syndrome and right head tilt. A soft tissue mass was observed in the right tympanic cavity, and bulla osteotomy was performed. Tissue samples retrieved from the tympanic cavity were sent for histology, and a middle ear fluid swab was sent for bacterial culture and sensitivity. Histologic diagnosis was of otitis media associated with cholesterol granuloma (CG). Bacterial culture yielded Pasteurella multocida and Leifsonia (Corynebacterium) aquaticum. Middle ear CG is frequently seen in human beings and is associated with a variety of middle ear diseases including otitis media. Cholesterol granuloma of the middle ear has been experimentally induced in cats. The clinical and pathological findings of a spontaneous case of CG in the tympanic cavity of a cat with otitis media are described herein.

Topics: Amoxicillin-Potassium Clavulanate Combination; Animals; Cat Diseases; Cats; Granuloma; Histocytochemistry; Male; Otitis Media

We sought to determine whether recurrent acute otitis media (rAOM) occurring within 30 days of amoxicillin/clavulanate treatment was caused by bacterial relapse or new pathogens.. Pneumococcal conjugate vaccinated children, age 6-36 months, enrolled in a prospective, longitudinal study experiencing rAOM<1 month after completing amoxicillin/clavulanate therapy were studied. AOM episodes occurred between June 2006 and November 2012. Multilocus sequence typing was used to genotype isolates.. Sixty-six children were in the study cohort; 63 otopathogens were recovered from middle ear fluid after tympanocentesis. Nontypeable Haemophilus influenzae (NTHi) accounted for 47% of initial AOMs versus 15% by Streptococcus pneumoniae (Spn), P<0.0001. NTHi accounted for 42% of rAOM versus 24% by Spn (P value=0.04). NTHi was the main otopathogen that caused true bacteriologic relapses (77%). β-lactamase-producing NTHi and penicillin nonsusceptible Spn were not more common in rAOM than initial AOM infections. Among 21 paired (initial and rAOM events) NTHi isolates genotyped, 13 (61.9%) were the same organism; 1 of 9 (11.1%) of paired Spn isolates was the same (P value=0.017). rAOM occurring within a week of stopping amoxicillin/clavulanate was a different pathogen in 21% of cases, 8-14 days later in 33%, 15-21 days in 41% and 22-30 days in 57% (P=0.04).. In amoxicillin/clavulanate-treated children, NTHi was the main otopathogen that caused true bacteriologic relapses. New pathogens causing rAOM versus persistence of the initial pathogen significantly increased week to week. Neither relapses nor new infections were caused more frequently by β-lactamase producing NTHi or penicillin nonsusceptible Spn.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child, Preschool; Cohort Studies; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Logistic Models; Male; Otitis Media; Pneumococcal Infections; Recurrence; Streptococcus pneumoniae

Recurrence acute otitis media (RAOM) may cause a considerable morbidity and a great parental concern. The aim of this study was to analyze the risk factors that are likely to be responsible for RAOM in infants, and their impact on treatment failure.. A retrospective study on 340 infants with RAOM was conducted. Data were collected from hospital charts. A 10 days course of amoxicillin/clavulanate was used for treatment of recurrence, while surgical management in the form of adenoidectomy and/or myringotomy was reserved for patients with persistent disease. We analyzed various risk factors that may affect the prognosis of RAOM, including: age, prematurity, upper respiratory tract infections (URTI), duration of breastfeeding, use of pacifiers, parental smoking, seasonality, the presence of siblings (family size), gender, adenoid hypertrophy, allergy, and craniofacial abnormalities.. Use of pacifiers, short duration of breastfeeding, older infantile age, winter season, URTI and presence of adenoid hypertrophy were identified as risk factors for RAOM. Treatment failure may be due to adenoid hypertrophy, short duration of breastfeeding and it is more common in older age infants. We did not find a significant association between RAOM and gender, prematurity, exposure to passive smoking, the presence of siblings, allergy, craniofacial abnormalities.. Factors that may cause recurrence of the disease in infant population are use of pacifiers, short duration of breastfeeding, older infantile age, winter season, upper respiratory tract infections and adenoid hypertrophy. Also, treatment failure may be caused by adenoid hypertrophy and short duration of breastfeeding. Good understanding of these factors may help to decrease the recurrence rate and to improve the treatment of the disease.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Breast Feeding; Cohort Studies; Female; Humans; Hypersensitivity; Incidence; Infant; Male; Otitis Media; Pacifiers; Prognosis; Recurrence; Respiratory Tract Infections; Retrospective Studies; Risk Factors; Seasons; Severity of Illness Index; Siblings; Time Factors; Tobacco Smoke Pollution

Early treatment of profound bilateral sensorineural hearing loss with cochlear implantation has become routine, resulting in an increased proportion of children implanted at younger ages. These children are at a relatively high risk for acute otitis media (AOM), and are more likely to develop mastoiditis in the implanted ear. Despite the significant risks associated with mastoiditis, including compromise of the implant, there are no specific guidelines on the management of this population. We propose a treatment algorithm emphasizing early but conservative operative intervention.. A retrospective chart review included eight patients, who experienced mastoiditis, in the context of cochlear implantation at our center from August 2005 to November 2012. During this period 806 implant surgeries were completed.. The median age at which mastoiditis occurred was 37 months, and the mean time from implantation to mastoiditis was 9.56 months. All patients underwent drainage of the middle ear in conjunction with intravenous antibiotics, and two additionally underwent post-auricular incision and drainage.. Recent mastoidectomy may be a risk factor for the development of a post-auricular abscess in children, who develop AOM following cochlear implantation. A treatment algorithm was developed, which emphasizes early operative drainage in conjunction with aggressive antibiotic therapy. Conclusions A consistent approach to the management of mastoiditis in children with cochlear implants has not been established. Rapid initiation of aggressive antibiotic therapy and a low threshold for conservative operative intervention results in effective resolution of infection while allowing preservation of the implant.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefprozil; Cefuroxime; Cephalexin; Cephalosporins; Child; Child, Preschool; Clindamycin; Cochlear Implantation; Cochlear Implants; Drainage; Female; Hearing Loss, Sensorineural; Humans; Infant; Infusions, Intravenous; Male; Mastoiditis; Otitis Media; Prosthesis-Related Infections; Retrospective Studies; Risk Factors

We sought to determine if use of more stringent diagnostic criteria for acute otitis media (AOM) than currently advocated by the American Academy of Pediatrics, tympanocentesis and pathogen-specific antibiotic treatment (individualized care) would result in reducing the incidence of recurrent AOM and consequent tympanostomy tube surgery.. A 5-year longitudinal, prospective study in Rochester, NY, was conducted from July 2006 to July 2011 involving 254 individualized care children. When this individualized care group developed symptoms of AOM, strict diagnostic criteria were applied and a tympanocentesis was performed. Pathogen resistance to empiric high-dose amoxicillin/clavulanate (80 mg/kg of amoxicillin component) caused a change in antibiotic to an optimized choice. Legacy controls (n = 208) were diagnosed with the same diagnostic criteria by the same physicians as the individualized care group and received the same empiric amoxicillin/clavulanate (80 mg/kg of amoxicillin component) but no tympanocentesis or change in antibiotic. Community control children (n = 1020) were diagnosed according to current American Academy of Pediatrics guidelines and treated with high-dose amoxicillin (80 mg/kg) without tympanocentesis as guideline recommended.. 5.9% of children of the individualized care group compared with 14.4% of Legacy controls and 27.3% of community controls became otitis prone, defined as 3 episodes of AOM within a 6-month time span or 4 AOM episodes within a 12-month time span (P < 0.0001). 2.4% of the individualized care group compared with 6.3% of Legacy controls, and 14.8% of community controls received tympanostomy tubes (P < 0.0001).. Individualized care of AOM significantly reduces the frequency of AOM and tympanostomy tube surgery. Use of strict diagnostic criteria for AOM and empiric antibiotic treatment using evidence-based knowledge of circulating otopathogens and their antimicrobial susceptibility profile also produces improved outcomes.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child, Preschool; Female; Humans; Infant; Kaplan-Meier Estimate; Male; Middle Ear Ventilation; New York; Otitis Media; Precision Medicine; Prospective Studies; Risk Factors; Seasons; Treatment Outcome

Drug hypersensitivity syndrome (DHS) is an idiosyncratic systemic reaction to a drug. The clinical presentation of this syndrome comprises a diverse spectrum, ranging from mild to fulminating organ failure. Nonspecific gastrointestinal symptoms are common in DHS, but severe morbidities and mortalities attributed to gut disease in DHS are rarely described. We present a case of DHS with significant gastrointestinal symptoms of prolonged profuse watery diarrhoea and persistent hypokalaemia requiring judicious intravenous water and electrolyte replacement. The symptoms resolved only after the introduction of intravenous hydrocortisone. It is important to consider intravenous corticosteroids if the gastrointestinal system is involved, as accelerated gut motility and mucosal damage would affect absorption of oral medications. Supportive treatment with the monitoring of fluid and electrolytes status and judicious replacement remains fundamental in the management of DHS patients with gut involvement.

Topics: Amoxicillin-Potassium Clavulanate Combination; Diarrhea; Drug Eruptions; Drug Hypersensitivity Syndrome; Edema; Electrolytes; Female; Gastrointestinal Diseases; Humans; Hydrocortisone; Middle Aged; Otitis Media; Prednisolone; Stomatitis

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child, Preschool; History, 20th Century; Humans; Infant; Otitis Media; Treatment Outcome

Acute otitis media is the most common respiratory tract infection in infancy and early childhood that is managed with antimicrobial agents. Ninety-three per cent of the cases diagnosed in Spain are treated with antibiotics, and Streptococcus pneumoniae and untypeable Haemophilus influenzae are the most frequently isolated pathogens. The aim of this work was to evaluate the usefulness of amoxicillin, amoxicillin/clavulanate and ceftriaxone for the empirical treatment of acute otitis media, looking at the pharmacokinetic variability and the antimicrobial susceptibility of paediatric strains of the two main pathogens responsible for AOM in Spain, Streptococcus pneumoniae and Haemophilus influenzae.. Free-drug plasma concentrations were simulated and the probability of target attainment at each minimum inhibitory concentration and the cumulative fraction of response (CFR) were determined. Microbiological susceptibility information was extracted from SAUCE 3 surveillance.. CFR with amoxicillin varied from 83% to 96% against S. pneumoniae and from 78% to 86% against H. influenzae. CFR was always >85% with amoxicillin/clavulanate. With the 3-day ceftriaxone regimen, the probability of achieving free concentrations above MIC at 72 hours significantly increased compared to the single dose, with which CFR ranged from 70% to 84%.. High-dose amoxicillin (at least 80 mg/kg/day) should be the first-line therapy in uncomplicated infections, whereas amoxicillin/clavulanate (40 mg/kg/day) should be the choice when additional coverage for H. influenzae is desired. Administration of 3 daily doses of ceftriaxone increases bacteriological eradication probability when compared with one-day regimen, although additional clinical evaluations are necessary to establish the best target attainment with ceftriaxone.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; beta-Lactam Resistance; Ceftriaxone; Child; Computer Simulation; Dose-Response Relationship, Drug; Haemophilus Infections; Haemophilus influenzae; Humans; Microbial Sensitivity Tests; Monte Carlo Method; Otitis Media; Pneumococcal Infections; Streptococcus pneumoniae

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Humans; Otitis Media

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Humans; Otitis Media; Watchful Waiting

Observation without initial antibiotic therapy was accepted as an option for acute otitis media (AOM) management in the 2004 American Academy of Pediatrics and American Academy of Family Physicians clinical practice guideline. The guideline also recommended amoxicillin as the first-line treatment for most children, and analgesic treatment to reduce pain if it was present. Our objective was to compare the management of AOM after publication of the 2004 guideline.. We analyzed the National Ambulatory Medical Care Survey, 2002-2006 (N = 1114), which occurred in US physicians' offices. The patients were children aged 6 months to 12 years who were diagnosed with AOM. The time comparisons were the 30-month periods before and after the guideline. The main outcome was the encounter rate at which no antibiotic-prescribing was reported. Secondary outcomes were the identification of factors associated with encounters at which no antibiotic-prescribing was reported and antibiotic- and analgesic-prescribing rates.. The rate of AOM encounters at which no antibiotic-prescribing was reported did not change after guideline publication (11%-16%; P = .103). Independent predictors of an encounter at which no antibiotic-prescribing was reported were the absence of ear pain, absence of reported fever, and receipt of an analgesic prescription. After guideline publication, the rate of amoxicillin-prescribing increased (40%-49%; P = .039), the rate of amoxicillin/clavulanate-prescribing decreased (23%-16%; P = .043), the rate of cefdinir-prescribing increased (7%-14%; P = .004), and the rate of analgesic-prescribing increased (14%-24%; P = .038).. Although management of AOM without antibiotics has not increased after the publication of the 2004 American Academy of Pediatrics and American Academy of Family Physicians clinical practice guideline, children who did not receive antibiotics were more likely to have mild infections. In accordance with the guideline, the prescribing of amoxicillin and analgesics has increased. Contrary to the guideline, the prescribing of amoxicillin/clavulanate has decreased, whereas the prescribing of cefdinir has increased.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Female; Guideline Adherence; Health Care Surveys; Humans; Infant; Logistic Models; Male; Otitis Media; Pediatrics; Practice Guidelines as Topic; Practice Patterns, Physicians'; United States

Overuse of broad-spectrum antibiotics is associated with antibiotic resistance. Acute otitis media (AOM) is responsible for a large proportion of antibiotics prescribed for US children. Rates of broad-spectrum antibiotic prescribing for AOM are unknown.. Analysis of the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey, 1998 to 2004 (N = 6,878). Setting is office-based physicians, hospital outpatient departments, and emergency departments. Patients are children aged 12 years and younger prescribed antibiotics for acute otitis media. Main outcome measure is percentage of broad-spectrum antibiotics, defined as amoxicillin/clavulanate, macrolides, cephalosporins and quinolones.. Broad-spectrum prescribing for acute otitis media increased from 34% of visits in 1998 to 45% of visits in 2004 (P < .001 for trend). The trend was primarily attributable to an increase in prescribing of amoxicillin/clavulanate (8% to 15%; P < .001 for trend) and macrolides (9% to 15%; P < .001 for trend). Prescribing remained stable for amoxicillin and cephalosporins while decreasing for narrow-spectrum agents (12% to 3%; P < .001 for trend) over the study period. Independent predictors of broad-spectrum antibiotic prescribing were ear pain, non-white race, public and other insurance (compared to private), hospital outpatient department setting, emergency department setting, and West region (compared to South and Midwest regions), each of which was associated with lower rates of broad-spectrum prescribing. Age and fever were not associated with prescribing choice.. Prescribing of broad-spectrum antibiotics for acute otitis media has steadily increased from 1998 to 2004. Associations with non-clinical factors suggest potential for improvement in prescribing practice.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cephalosporins; Child; Child, Preschool; Drug Utilization; Humans; Infant; Macrolides; Otitis Media; United States

We report a case of Lemierre syndrome in a healthy infant, initially presenting with otitis media and angina. Lemierre syndrome is a disease that every pediatrician must know. Early diagnosis and treatment with antibiotics are necessary to decrease mortality. A review of the history and the complications of Lemierre syndrome is presented.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Cefotaxime; Child; Drug Therapy, Combination; Female; Follow-Up Studies; Fusobacterium Infections; Fusobacterium necrophorum; Gentamicins; Hospitalization; Humans; Jugular Veins; Length of Stay; Metronidazole; Otitis Media; Pharyngitis; Syndrome; Time Factors; Tomography, X-Ray Computed; Venous Thrombosis

During surgical procedure, antibioprophylaxis is known to decrease bacterial proliferation and limit postoperative complications such as infections. In France, antibiotic prescription guidelines have been established for ear surgery, but applied with discrepancies. The purpose of the study was to evaluate the necessity of antibioprophylaxis in ear surgery.. Retrospective study of two consecutives series of ear surgery with two different antibioprophylaxis protocols. In the first series (n=100), antibioprophylaxis by amoxicillin and clavulanic acid was given only in cases of chronic otitis media with otorrhea and cholesteatoma (contaminated surgery). In the second series (n=107), no antibiotic was administered. The number of infected complications was evaluated by reviewing medical charts.. The percentage of infected complications was 5% versus 6.5% in the second series (with no antibioprophylaxis), for all types of ear surgery, 9.4% versus 4.2% after ear contaminated surgery. No statistical difference was observed between the two series.. In ear surgery, postoperative infected complications do not more frequently occur without antibioprophylaxis, either in otorrhea or in cholesteatoma surgery.

Topics: Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Antibiotic Prophylaxis; Cerebrospinal Fluid Otorrhea; Cholesteatoma, Middle Ear; Female; Humans; Male; Middle Aged; Otitis Media; Otologic Surgical Procedures; Preoperative Care

To evaluate the efficacy and safety of CLAVAMOX dry syrup (potassium clavulanate/amoxicillin) in children with otitis media, we conducted a postmarketing surveillance from February to September 2006. The analysis was made on the basis of 470 survey sheets collected from 127 medical institutions, of which we investigated 455 cases for safety, and 433 cases for efficacy. The efficacy was 95.2% in the 433 subjects eligible for the efficacy analysis. The clinical improvement rates for major symptoms (otalgia, otorrhea, flare reaction of drum membrane and fever) were 95% or more. The efficacies for the three major offending bacteria of otitis media (Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis) were between 94.6% and 100%. The efficacies for penicillin-resistant Streptococcus pneumoniae (PRSP) and penicillin intermediate resistant Streptococcus pneumoniae (PISP) were 95% or more. Adverse drug reactions (ADRs) were reported in 106 (23.3%) of the 455 subjects eligible for safety analysis. The major ADRs were diarrhea, of which incident was 22.6% (103 of 455). These ADRs were observed at a higher rate in younger age patients. Most of the diarrhea cases were non-serious, reversible on discontinuation or continuation of the drug. No clinically important serious diarrhea cases such as pseudomembranous colitis or dehydration were observed. Our surveillance results demonstrated that CLAVAMOX dry syrup had excellent efficacy and clinically manageable safety in children with otitis media. These findings indicated that this medicine was clinically-useful in children with otitis media.

Topics: Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Dosage Forms; Drug-Related Side Effects and Adverse Reactions; Female; Haemophilus influenzae; Humans; Infant; Male; Moraxella catarrhalis; Otitis Media; Product Surveillance, Postmarketing; Prospective Studies; Streptococcus pneumoniae

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Humans; Infant; Otitis Media; Time Factors

To determine outcomes in acute otitis media (AOM) according to severity of disease and to assess different initial treatment regimens, 308 with AOM were enrolled and divided into severe (n = 277; 89.9%) and non-severe (n = 31; 10.1%) groups based on symptoms and tympanic membrane changes. Children in the severe group were initially managed with amoxicillin (AMPC) whereas children in the non-severe group were initially managed without antibiotics. Children were monitored on days 1, 5, 10, 14 and 28. Five outcome measures were assessed: disappearance of symptoms at day 5, resolution of tympanic membrane changes by day 28, disappearance of middle ear effusions by day 28, recurrence of acute symptoms prior to day 28, and need to change treatment regimens. Children with severe disease were more often male (57% versus 36%, P < 0.05) and more often colonized with pathogens (77% versus 55%, P < 0.05 than children with non-severe disease. The two groups were similar with respect to age and day care attendance. Despite differences in initial treatment regimens between the two groups, symptoms improved at the same rate for severe and non-severe disease, 94% by day 5. In contrast, tympanic membranes returned to normal in 69% of the severe and 81% of the non-severe groups by day 28; however, as early as day 5, 10% of the severe and 55% of the non-severe groups demonstrated normal tympanic membranes. Middle ear effusions similarly disappeared more slowly in the severe group, 52% versus 74% by day 14 and 76% versus 84% by day 28. Recurrence rates of acute symptoms occurred with equal frequency in the severe, 15%, and non-severe groups, 10%. Failure of the symptoms or the tympanic membranes to improve led to antibiotic changes in 59.9% of the severe group and to the addition of antibiotics in 51.6% of the non-severe group. Children in the severe group who failed to improve with an initial course of amoxicillin were younger (40.2 months versus 45.8 months, P < 0.05), had higher tympanic membrane scores (4.5 versus 4.1, P < 0.05), and were more often colonized with penicillin-resistant Streptococcus pneumoniae (33.8% versus 6.5%, P < 0.01) than children who responded to AMPC. In a similar manner, children with non-severe disease who failed to improve without antibiotics were younger (40.7 months versus 54.8 months, P < 0.05) and more often colonized with pathogens (75.0% versus 33.4%, P < 0.05).. Severe disease occurred more often among males and among children colonized with pathogens. Response to treatment was impaired in younger children and in children colonized with pathogens, especially penicillin-resistant Streptococcus pneumoniae.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Epidemiologic Methods; Female; Humans; Infant; Male; Nasopharynx; Otitis Media; Pneumococcal Infections; Sex Factors; Treatment Outcome

Autism is an ever increasing problem in the United States. Characterized by multiple deficits in the areas of communication, development, and behavior; autistic children are found in every community in this country and abroad. Recent findings point to a significant increase in autism which can not be accounted for by means such as misclassification. The state of California recently reported a 273% increase in the number of cases between 1987 and 1998. Many possible causes have been proposed which range from genetics to environment, with a combination of the two most likely. Since the introduction of clavulanate/amoxicillin in the 1980s there has been the increase in numbers of cases of autism. In this study 206 children under the age of three years with autism were screened by means of a detailed case history. A significant commonality was discerned and that being the level of chronic otitis media. These children were found to have a mean number 9.96 bouts of otitis media (with a standard error of the mean of +/-1.83). This represents a sum total for all 206 children of 2052 bouts of otitis media. These children received a mean number of 12.04 courses of antibiotics (standard error of the mean of +/-.125). The sum total number of courses of antibiotics given to all 206 children was 2480. Of those 893 courses were Augmentin. with 362 of these Augmentin courses administered under the age of one year. A proposed mechanism whereby the production of clavulanate may yield high levels of urea/ammonia in the child is presented. Further an examination of this mechanism needs to be undertaken to determine if a subset of children are at risk for neurotoxicity from the use of clavulanic acid in pharmaceutical preparations.

Topics: Amoxicillin-Potassium Clavulanate Combination; Autistic Disorder; Drug Therapy, Combination; Humans; Otitis Media; Risk Factors; Urea

A gerbil model of acute otitis media induced by Streptococcus pneumoniae plus Haemophilus influenzae was used to assess the efficacy of amoxicillin/clavulanic acid (A/C) (1.5/0.3, 2.5/0.5 and 10/2 mg/kg) and erythromycin (2.5, 10, 20 and 50 mg/kg) with or without acetaminophen. The amoxicillin/clavulanic acid MIC was 1/0.5 mg/l for both organisms and the erythromycin MICs were 0.12 and 4 mg/l for S. pneumoniae and H. influenzae, respectively. The organisms were inoculated directly into the middle ear (ME) and antibiotic treatment started 2 h post-inoculation and continued at 8h intervals for three doses. Acetaminophen was administered at 50 mg/kg. Samples for bacterial counting were obtained from the ME on day 2. Amoxicillin/clavulanic acid peri-MIC concentrations in ME were effective in eradicating both organisms. Despite the inflammation induced by S. pneumoniae, erythromycin did not eradicate H. influenzae at ME concentrations (2.4 mg/l for erythromycin 50 mg/kg) higher than those obtained in humans but lower than the MIC.

Topics: Amoxicillin-Potassium Clavulanate Combination; Animals; Disease Models, Animal; Drug Therapy, Combination; Erythromycin; Gerbillinae; Haemophilus Infections; Haemophilus influenzae; Microbial Sensitivity Tests; Otitis Media; Pneumococcal Infections; Streptococcus pneumoniae

To describe patterns observed in the treatment of acute otitis media (AOM) in several locations of five countries.. Cross-sectional, descriptive study. Random sample of 12,264 paediatric outpatients seen by paediatricians or general practitioners (GPs). Data on patient demographics, diagnoses and treatment were collected. Diagnoses were coded by ICD-9 and drugs by ATC classification. Patients diagnosed with AOM (ICD-9 codes: 381 and 382) were selected for analysis.. Cases of AOM (873) accounted for 7.1% of the sample. There is a clear variation in the percentage of children diagnosed with AOM and treated with antibiotics in the different locations, antibiotic prescriptions being higher in Barcelona (93% of children), and lowest in Smolensk (56.4 % of children were treated without antibiotics). The antibiotics used varied widely: ampicillin use is almost limited to Smolensk (26.7%) and Bratislava (13.8%), whereas amoxicillin plus clavulanic acid is the choice in Toulouse (33.8%), Valencia (30.2%) and Barcelona (28.9%), and cephalosporins are more frequently prescribed in Tenerife (51.7%). Finally, macrolides are used in Barcelona (18.3%), Valencia (17.5%) and Tenerife (13.6%), but not prescribed in Toulouse or Sofia. Prescriptions of anti-inflammatory drugs were only relevant in Valencia (31.7%), Tenerife (27.2%) and Toulouse (17.4%) and of otological preparations in Sofia, where almost each child received ear drops (91.9%). Nasal preparations are commonly used only in Sofia (41.9%), Bratislava (65.5%) and Smolensk (68.6%).. Despite the general agreement of most guidelines, wide differences in the treatment of uncomplicated AOM in children are observed. Non-antibiotic therapy for AOM and the use of first-choice antibiotics should be more actively encouraged in the primary care centres. Studies to measure prevailing rates of antibiotic resistance in these populations are needed.

Topics: Acute Disease; Administration, Topical; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Inflammatory Agents; Cephalosporins; Child; Cross-Sectional Studies; Drug Prescriptions; Drug Utilization Review; Europe; Europe, Eastern; Humans; International Classification of Diseases; Macrolides; Otitis Media; Practice Patterns, Physicians'

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Dose-Response Relationship, Drug; Humans; Infant; Otitis Media; Randomized Controlled Trials as Topic; Recurrence; Reproducibility of Results

Nasopharyngeal cultures were obtained from 60 children with acute otitis media before and after treatment with either 45 or 90 mg of amoxicillin (given as amoxicillin-clavulanate) per kg of body weight per day for 10 days. The number of Streptococcus pneumoniae isolates in the 45-mg/kg group was reduced from 12 to 6 and was reduced from 14 to 1 (P = 0.0261) in the 90-mg/kg group.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Nasopharynx; Otitis Media; Penicillins; Pneumococcal Infections; Streptococcus pneumoniae

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Drug Therapy, Combination; Haemophilus influenzae; Humans; Otitis Media; Research Design; Streptococcus pneumoniae

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Drug Therapy, Combination; Haemophilus influenzae; Humans; Otitis Media; Research Design; Streptococcus pneumoniae; Treatment Outcome

The effects of co-amoxiclav (AMC) and amoxicillin (AMX) therapy on the nasopharyngeal flora of children with acute otitis media (AOM) were compared. Nasopharyngeal culture for aerobic and anaerobic bacteria were obtained before therapy and 2-4 days after completion of antimicrobial therapy in 25 patients treated with either antibiotic. After therapy, 16 (64%) of the 25 patients treated with AMX and 23 (92%) of the 25 patients treated with AMC were considered clinically cured. Polymicrobial aerobic-anaerobic flora were present in all instances. A significant reduction in the number of both aerobic and anaerobic isolates occurred after therapy in those treated with AMX (177 isolates versus 133, P< 0.005) and AMC (172 isolates versus 60, P< 0.001). However, the number of all isolates recovered after therapy in those treated with AMC was significantly lower (60 isolates) than in those treated with AMX (133 isolates, P < 0.001). The recovery of known aerobic pathogens (e.g. Streptococcus pneumoniae, Staphylococcus aureus, beta-haemolytic streptococci, Haemophilus species and Moraxella catarrhalis) and penicillin-resistant bacteria after therapy was lower in the AMC group than in the AMX group (P < 0.005). This study illustrates the greater ability of AMC, compared with AMX, to reduce the number of potential nasopharyngeal pathogens and penicillin-resistant bacteria in children with AOM.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteria; beta-Lactamases; Drug Therapy, Combination; Humans; Nasopharynx; Otitis Media; Penicillin Resistance; Penicillins

To determine the current management of acute otitis media by New Zealand general practitioners (GPs).. A reply-paid questionnaire was sent to 2000 New Zealand GPs. The questions relate to management of a three year old child presenting with her first episode of acute otitis media.. 95% of respondents reported they would usually or always use antibiotics. Amoxicillin was the antibiotic of choice, followed by amoxicillin/clavulanate. Cotrimoxazole was the antibiotic of choice in the case of allergy to amoxicillin. 82% of respondents recommended follow-up, with a broad range of follow-up times (24 hours to 12 weeks). Approximately half of practitioners considered 5-6 episodes of acute otitis media in a year as an appropriate threshold for referral for grommets. Most GPs had received an update on otitis media within the previous two years.. There is considerable variation in the management of acute otitis media by New Zealand GPs. Use of a national guideline may result in a more standardised, rational approach to the treatment of acute otitis media.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Child, Preschool; Drug Therapy, Combination; Humans; New Zealand; Otitis Media; Penicillins; Physicians, Family; Practice Patterns, Physicians'; Surveys and Questionnaires; Trimethoprim, Sulfamethoxazole Drug Combination

Topics: Amoxicillin-Potassium Clavulanate Combination; Bronchial Spasm; Bronchitis; Child; Child, Preschool; Female; Humans; Male; Otitis Media; Tooth Discoloration

The efficacy of amoxicillin/clavulanate and cefuroxime was determined in a gerbil model of otitis media with a mixed Streptococcus pneumoniae plus Haemophilus influenzae middle ear (ME) infection. Results were compared with those obtained in a previous single H. influenzae model. All untreated animals inoculated with the mixed inoculum developed acute otitis media (AOM), whereas 86.7% of those inoculated with H. influenzae developed otitis media with effusion (OME). Antibiotics eradicated H. influenzae from the ME more efficiently in AOM than in OME, and this difference was highly significant (P80% of animals developed culture-negative OME.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Animals; Cefuroxime; Cephalosporins; Colony Count, Microbial; Disease Models, Animal; Drug Therapy, Combination; Female; Gerbillinae; Haemophilus Infections; Haemophilus influenzae; Humans; Microbial Sensitivity Tests; Otitis Media; Otitis Media with Effusion; Pneumococcal Infections; Streptococcus pneumoniae

Topics: Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Drug Therapy, Combination; Humans; Infant; Infant, Newborn; Otitis Media; Penicillins; Referral and Consultation

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

FAILURES OF ANTIBIOTIC TREATMENT: The number of failures after treatment of acute middle ear infections with the 2 main antibiotics prescribed (amoxicillin and the combination amoxicillin-clavulanic acid) is on the rise. These failures appear to be related to increased resistance of the 2 principal pathogens, pneumococci and Hemophilus influenzae. A NEW FORMULATION: In order to reduce the rate of failure, it has been necessary to both increase the dose of penicillin to overcome the reduced susceptibility of pneumococci to penicillin and to prescribe a beta-lactam because of the frequent isolation of beta-lactamase producing Hemophilus influenzae. A new formulation has been developed where the amoxicillin-clavulanic acid dose is 14 to 1. This allows a daily dose of 80 mg/kg for amoxicillin and 6.4 mg/kg for clavulanic acid. In one open multicentric study including 51 pediatric patients aged 3 to 48 months with acute middle ear infections, it was demonstrated that this new formulation can be very effective in eradicating the causal agents of acute middle ear infections, including pneumococci and penicillin-resistant Hemophilus. RECOMMENDATIONS FOR GOOD EFFICACY: Amoxicillin must always be prescribed, either alone or in combination with clavulanic acid, at the dose of 45 to 50 mg/kg b.i.d. the amoxicillin-clavulanic acid combination should be preferred for children under 2 years due to the risk of beta-lactamase producing Hemophilus.

Topics: Amoxicillin-Potassium Clavulanate Combination; Chemistry, Pharmaceutical; Drug Therapy, Combination; Haemophilus Infections; Haemophilus influenzae; Humans; Otitis Media; Penicillin Resistance; Streptococcus pneumoniae

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Drug Therapy, Combination; Erythema Multiforme; Female; Humans; Infant; Otitis Media

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Ceftriaxone; Cephalosporins; Child; Drug Resistance, Microbial; Drug Therapy, Combination; Humans; Otitis Media; Practice Patterns, Physicians'; Streptococcus pneumoniae

Topics: Acute Disease; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Anti-Inflammatory Agents; Audiometry; Bone Conduction; Cefuroxime; Cephalosporins; Ciprofloxacin; Drug Therapy, Combination; Facial Paralysis; Female; Follow-Up Studies; Glucocorticoids; Hearing Loss; Hearing Loss, Conductive; Humans; Male; Middle Aged; Otitis Media; Penicillins; Prednisone; Trimethoprim, Sulfamethoxazole Drug Combination; Tympanic Membrane

The effect on the nasopharyngeal bacterial flora of therapy for 10 days with co-amoxiclav or cefprozil was studied in 50 children with acute otitis media. Before therapy, potential pathogens (Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis) were isolated in 14 (56%) of those treated with co-amoxiclav and 15 (60%) of those treated with cefprozil. Following therapy, the reduction in the number of these pathogens was the same in the two groups. However, differences between the groups were noted in the recovery of organisms with interfering capability, namely alpha-haemolytic streptococci, Peptostreptococcus anaerobius and Prevotella melaninogenica. Fifty interfering organisms were recovered from each group before therapy. After therapy with co-amoxiclav or cefprozil their number declined to 11 and 42, respectively (P< 0.001).

Topics: Amoxicillin-Potassium Clavulanate Combination; Antibiosis; Cefprozil; Cephalosporins; Child, Preschool; Drug Therapy, Combination; Female; Gram-Negative Bacteria; Gram-Positive Cocci; Humans; Infant; Male; Nasopharynx; Otitis Media

Otitis media is recognized as one of the most common diseases of childhood. Insertion of tympanostomy tubes for the treatment of otitis media is the most frequently performed otologic operation, and postoperative otorrhea is its most common complication. Many authors have suggested various reasons for posttympanostomy otorrhea, and many different prophylactic treatments were proposed in recent years to prevent this bothersome and frustrating complication. This retrospective study was designed to investigate and compare the efficacy of various prophylactic treatments and to define the most effective method of reducing the rate of postoperative otorrhea.

Topics: Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotic Prophylaxis; Cerebrospinal Fluid Otorrhea; Child; Child, Preschool; Female; Gentamicins; Humans; Incidence; Infant; Instillation, Drug; Male; Middle Ear Ventilation; Otitis Media; Penicillins; Postoperative Care; Retrospective Studies; Treatment Outcome

Topics: Administration, Oral; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Child; Child, Preschool; Cholesteatoma, Middle Ear; Chronic Disease; Ciprofloxacin; Clinical Trials as Topic; Drug Therapy, Combination; Humans; Multicenter Studies as Topic; Otitis Media; Otitis Media with Effusion; Prospective Studies; Time Factors

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Drug Therapy, Combination; Humans; Otitis Media; Penicillins

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Drug Administration Schedule; Drug Therapy, Combination; Humans; Otitis Media; Penicillins

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Clavulanic Acids; Humans; Microbial Sensitivity Tests; Otitis Media; Penicillin Resistance; Streptococcus pneumoniae

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Drug Resistance, Microbial; Drug Therapy, Combination; Europe; Female; Humans; Infant; Israel; Male; Microbial Sensitivity Tests; Otitis Media; Pneumococcal Infections; Streptococcus pneumoniae; United States

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ceftriaxone; Cephalosporins; Child; Clavulanic Acids; Drug Therapy, Combination; Humans; Otitis Media; Parents; Treatment Failure

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

This study was designed to test the in-vitro activity of four oral antibiotics against the four microorganisms most frequently isolated in acute otitis media: beta-lactamase-positive Haemophilus influenzae (N = 10), beta-lactamase-positive Moraxella catarrhalis (N = 10), penicillin-sensitive Streptococcus pneumoniae (N = 11) and methicillin-sensitive Staphylococcus aureus (N = 10), by the bactericidal curve method. Bactericidal kinetics were determined for concentrations of antibiotic equivalent to those found in the middle ear after treatment: amoxycillin-clavulanic acid (2.5 mg l-1/0.6 mg l-1 and 2.5 mg l-1/1.2 mg l-1), cefaclor (1 mg l-1), erythromycin (0.5 mg l-1) and erythromycin/sulfisoxazole (0.2/3 mg l-1). The inoculum was of 10(6) colony-forming units (cfu) ml-1. The bacterial counts were performed after 5 h and 24 h using a spiral inoculator system. The results showed that amoxycillin-clavulanic acid had rapid bactericidal activity (< 24 h) on the tested organisms at each of the doses used (reduction < or = 3 log10 cfu ml-1) which was not observed with the other antibiotics at either 5 or 24 h. Erythromycin alone or combined with sulfisoxazole had a bacteriostatic effect on Moraxella catarrhalis and Streptococcus pneumoniae but not on Haemophilus influenzae or Staphylococcus aureus. Cefaclor had no bactericidal action under these conditions.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefaclor; Child, Preschool; Clavulanic Acids; Colony Count, Microbial; Drug Therapy, Combination; Erythromycin; Gram-Negative Bacteria; Gram-Positive Bacteria; Haemophilus influenzae; Humans; Infant; Microbial Sensitivity Tests; Moraxella catarrhalis; Otitis Media; Staphylococcus aureus; Streptococcus pneumoniae; Sulfisoxazole

Acute otitis media is diagnosed commonly in the pediatric population. Numerous complications, one of which is facial palsy, may result. Facial paralysis may be the initial complaint in the child in whom acute otitis media later develops on the affected side, as was true in the case reported here. Dehiscence of the fallopian canal, physiologic canaliculi along the facial nerve to the periphery, and host resistance play an integral part in the development of facial nerve palsy from acute otitis media. The two most effective neurodiagnostic studies are the nerve excitability test and electromyography. The author also recommends daily acoustic reflex testing for denervation or reinnervation. Specific indications for conservative therapy (myringotomy, antibiotic, and decongestant) as well as for surgical intervention are discussed. The treatment in the present case was particularly conservative. It included only a broad-spectrum antibiotic, with good results.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acids; Drug Therapy, Combination; Electromyography; Facial Paralysis; Humans; Infant; Male; Neurologic Examination; Otitis Media