amoxicillin-potassium-clavulanate-combination and Otitis-Media-with-Effusion

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

In two randomized clinical trials in children with otitis media, the efficacy and safety of cefprozil are compared to those of amoxicillin/clavulanate (n = 530) and of cefaclor and cefixime (n = 394). The rate of clinical cure or improvement was similar among patients receiving each drug regimen, ranging from 78% for amoxicillin/clavulanate to 89% for cefaclor; for cefprozil, this rate was 84% and 85% in the two studies, respectively. In the first study, cefprozil was superior to amoxicillin/clavulanate in the satisfactory clinical response rate for Streptococcus pneumoniae (P = .049), but response rates were similar for Haemophilus influenzae and Moraxella catarrhalis. Significantly more patients treated with amoxicillin/clavulanate (P less than .001) in the first study or cefixime (P less than .01) in the second study developed diarrhea than did those treated with cefprozil. We conclude that cefprozil therapy for otitis media in children produces clinical and bacteriologic response rates similar to those seen with amoxicillin/clavulanate, cefixime, or cefaclor. Furthermore, diarrhea was significantly less common with cefprozil than with cefixime or amoxicillin/clavulanate.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Cefaclor; Cefixime; Cefotaxime; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Humans; Infant; Otitis Media with Effusion

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

Acute otitis media (AOM) induces middle-ear effusion (MEE), which affects hearing. The effect of antimicrobial treatment on the resolution of MEE is controversial, and the factors that affect resolution are unknown.. We studied the effect of antimicrobial treatment on the time to the resolution of MEE as a secondary objective in our randomized double-blind placebo-controlled trial. Children aged 6 to 35 months with stringently diagnosed AOM were allocated to receive amoxicillin-clavulanate (161 patients) or placebo (158 patients) for 7 days and closely followed for 3 months. This study was registered at ClinicalTrials.gov (identifier NCT00299455).. The median times to resolution of MEE were 20 days (95% confidence interval [CI], 16-24 days) and 29 days (95% CI, 26-32 days) in the amoxicillin-clavulanate and placebo groups, respectively (P = .10). The resolution of MEE was confirmed in 138 (86%) of 161 and 132 (84%) of 158 patients in the amoxicillin-clavulanate and placebo groups, respectively (P = .59). In multivariable analysis, the resolution of MEE was prolonged most significantly by at least 1 recurrence of AOM during follow-up. MEE resolved in 65 (65%) of 100 patients with a recurrence of AOM during follow-up and in 205 (94%) of 219 of those without a recurrence (P < .001) (median times to resolution, 67 vs 15 days, respectively; P < .001).. Immediate antimicrobial treatment of AOM does not significantly affect the resolution of MEE in young children. Subsequent recurrences of AOM are a major reason for the persistence of MEE.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Child, Preschool; Double-Blind Method; Female; Humans; Infant; Male; Otitis Media with Effusion; Remission Induction

Recent guidance for the management of acute otorrhea in children with tympanostomy tubes is based on limited evidence from trials comparing oral antibiotic agents with topical antibiotics.. In this open-label, pragmatic trial, we randomly assigned 230 children, 1 to 10 years of age, who had acute tympanostomy-tube otorrhea to receive hydrocortisone-bacitracin-colistin eardrops (76 children) or oral amoxicillin-clavulanate suspension (77) or to undergo initial observation (77). The primary outcome was the presence of otorrhea, as assessed otoscopically, 2 weeks after study-group assignment. Secondary outcomes were the duration of the initial otorrhea episode, the total number of days of otorrhea and the number of otorrhea recurrences during 6 months of follow-up, quality of life, complications, and treatment-related adverse events.. Antibiotic-glucocorticoid eardrops were superior to oral antibiotics and initial observation for all outcomes. At 2 weeks, 5% of children treated with antibiotic-glucocorticoid eardrops had otorrhea, as compared with 44% of those treated with oral antibiotics (risk difference, -39 percentage points; 95% confidence interval [CI], -51 to -26) and 55% of those treated with initial observation (risk difference, -49 percentage points; 95% CI, -62 to -37). The median duration of the initial episode of otorrhea was 4 days for children treated with antibiotic-glucocorticoid eardrops versus 5 days for those treated with oral antibiotics (P<0.001) and 12 days for those who were assigned to initial observation (P<0.001). Treatment-related adverse events were mild, and no complications of otitis media, including local cellulitis, perichondritis, mastoiditis, and intracranial complications, were reported at 2 weeks.. Antibiotic-glucocorticoid eardrops were more effective than oral antibiotics and initial observation in children with tympanostomy tubes who had uncomplicated acute otorrhea. (Funded by the Netherlands Organization for Health Research and Development; Netherlands Trial Register number, NTR1481.).

Topics: Administration, Oral; Administration, Topical; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacitracin; Child; Child, Preschool; Colistin; Drug Combinations; Female; Glucocorticoids; Humans; Hydrocortisone; Infant; Kaplan-Meier Estimate; Male; Middle Ear Ventilation; Otitis Media with Effusion

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

To compare the bacteriologic and clinical efficacy of amoxicillin/clavulanate and azithromycin in patients with acute otitis media (AOM), particularly the ability to eradicate the predominant AOM pathogens from middle ear fluid as assessed by mandatory second tympanocentesis.. In this single blind study 238 infants and children with AOM were randomized to receive amoxicillin/clavulanate (45/6.4 mg/kg/day in two divided doses for 10 days) or azithromycin (10 mg/kg on Day 1, then 5 mg/kg daily on Days 2 through 5). Tympanocentesis was performed before the first dose and repeated on Day 4, 5 or 6. Clinical response was assessed at end of therapy between Days 12 and 14 and at follow-up between Days 22 and 28.. Amoxicillin/clavulanate was significantly more likely to eradicate all bacterial pathogens [83% (54 of 65) vs. 49% (35 of 71), P = 0.001] and Haemophilus influenzae [87% (26 of 30) vs. 39% (13 of 33), P = 0.0001] from middle ear fluid than was azithromycin. Amoxicillin/clavulanate was also more likely to eradicate Streptococcus pneumoniae, but the difference was not statistically significant [90% (18 of 20) vs. 68% (13 of 19) [corrected], P = 0.095]. On Days 12 to 14, signs and symptoms were more likely to resolve completely or improve in all culture-positive patients [86% (60 of 70) vs. 70% (51 of 73), P = 0.023] and in those with H. influenzae infections [91% (30 of 33) vs. 65% (22 of 34), P = 0.010] who received amoxicillin/clavulanate compared with those who received azithromycin. Otherwise there were no significant differences between groups in clinical outcomes on Days 12 to 14 or at follow-up.. Our findings indicate that amoxicillin/clavulanate has superior bacteriologic and clinical efficacy compared with azithromycin in children with AOM.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child, Preschool; Female; Haemophilus influenzae; Humans; Infant; Male; Microbial Sensitivity Tests; Moraxella catarrhalis; Otitis Media with Effusion; Penicillins; Single-Blind Method; Streptococcus pneumoniae; Treatment Outcome

To compare the efficacy and the safety of a single intramuscular dose of ceftriaxone, 50 mg/kg, vs. a 10-day course of amoxicillin/clavulanate (amox/clav) therapy, 80 mg/kg/day of amoxicillin: 10 mg/kg/day of clavulanate in three divided doses, in children with acute otitis media (AOM) and to evaluate the changes in nasopharyngeal flora after treatment.. In a prospective, comparative, open randomized, multicenter trial, children were scheduled to return for visits on Days 12 to 14 (main end point) and Days 28 to 42 after the beginning of treatment for AOM. A nasopharyngeal swab for bacterial culture was obtained before the treatment and at Days 12 to 14.. Between February, 1995, and May, 1996, 513 children with a mean age of 14.2 +/- 6.7 months were enrolled. All the patients were evaluable for the safety and intent-to-treat analyses and 463 for the per protocol efficacy. At Days 12 to 14 clinical success was obtained in 186 of the 235 children (79%) given ceftriaxone and in 188 of the 228 children (82.5%) treated with amox/clav. Among the patients with clinical success on Days 12 to 14, the success was maintained at Days 28 to 42 for 108 of 183 (59%) patients in the ceftriaxone group and 103 of 187 (55%) patients in the amox/clav group. Before the antibiotic treatment the percentages of children carrying Streptococcus pneumoniae (59.1%), Haemophilus influenzae (39.4%), Moraxella catarrhalis (55.7%) and the rate of penicillin-resistant S. pneumoniae (52.2%) were comparable between the 2 groups. At Days 12 to 14 the carriage of S. pneumoniae and M. catarrhalis was significantly different between the patients treated with ceftriaxone, 43.9 and 42.2, respectively, and the patients treated with amox/clav, 17.4 and 11.1%, respectively. Among the children carrying S. pneumoniae at Days 12 to 14, the percentage of penicillin-resistant strains reached 63.4% in the ceftriaxone treatment group and 83.0% in the amox/clav treatment group, (P = 0.02). Adverse events (mainly diarrhea) related to the study medication were reported more frequently (P < 0.0001) in the amox/clav treatment group.. In an area with a high rate of penicillin-resistant S. pneumoniae, a single dose of ceftriaxone is as efficient as a 10-day course of amox/clav in the treatment of AOM in young children. There was for the two regimens an increased rate of penicillin-resistant strains among the pneumococci carried, whereas the chance for a child to carry a penicillin resistant S. pneumoniae did not increase after treatment.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Ceftriaxone; Cephalosporins; Child, Preschool; Drug Administration Schedule; Female; Haemophilus influenzae; Humans; Infant; Male; Moraxella catarrhalis; Nasopharynx; Otitis Media with Effusion; Prospective Studies; Streptococcus pneumoniae; Treatment Outcome

Otitis media is a common infection of childhood. Increasing antibiotic resistance rates among the principal causative pathogens, Streptococcus pneumoniae and Haemophilus influenzae, are associated with failure of first line agents.. This open, randomized, multicenter study compared the clinical efficacy of a short 5-day course of cefuroxime axetil (CAE) suspension with that of amoxicillin/clavulanate (A/CA) suspension for 8 or 10 days.. Children age 6 to 36 months with acute otitis media with effusion, diagnosed by tympanocentesis and microbiologic culture, were randomized to receive CAE (30 mg/kg/day in two divided doses for 5 days) or A/CA 40 mg/kg/day in three divided doses for 10 days (A/CA-10). In French centers A/CA was given at 80 mg/kg/day in three divided doses for 8 days (A/CA-8). Patients were assessed 1 to 4 days after completing the course (posttreatment) and followed up at 21 to 28 days after completing the course.. Of the 716 patients randomized, 252 were treated with CAE, 255 with A/CA-10 and 209 with A/CA-8. In the clinically evaluable population, the proportions of patients with clinical cure at posttreatment were 175 of 203 (86%), 181 of 205 (88%) and 145 of 164 (88%) in the CAE, A/CA-10 and A/CA-8 groups, respectively, demonstrating equivalence among the three treatments. For patients <18 months old, clinical cures were 111 of 134 (83%), 116 of 131 (89%) and 83 of 99 (84%) in the CAE, A/CA-10 and A/CA-8 groups, respectively; equivalence was also demonstrated. At follow-up, 130 of 175 (74%) CAE, 121 of 172 (70%) A/CA-10, and 112 of 142 (79%) A/CA-8 had maintained cure. A total of 837 pretreatment pathogens were isolated from middle ear fluid in 73% (522 of 716) patients, the majority of isolates were S. pneumoniae (30%) and H. influenzae (27%). The most common adverse events were gastrointestinal, the incidence of drug-related diarrhea being higher in the A/CA-10 group (18%) than in either the CAE or A/CA-8 groups (10%).. A 5-day course of CAE, given twice daily, was shown to be equivalent to the two regimens of A/CA for treatment of acute otitis media with effusion in children.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cefuroxime; Cephalosporins; Child, Preschool; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media with Effusion; Treatment Outcome

A total of 386 children, aged 1-10, with secretory otitis media for at least 3 months were randomly allocated to 2 or 4 weeks' treatment with penicillin-V (Primcillin) or amoxicillin + clavulanic acid (Spektramox). Spektramox was superior (p < 0.01) to Primcillin in eradicating Haemophilus influenzae and Branhamella catarrhalis from the nasopharynx. No difference was noted for Streptococcus pneumoniae and haemolytic streptococci, gr. A, B, C, G. No increase in the number of beta-lactamase-producing bacteria was noted after treatment. The nasopharynx was recolonized with the same bacteria within 4 weeks from cessation of treatment.

Topics: Amoxicillin-Potassium Clavulanate Combination; Bacteria; Child; Child, Preschool; Colony Count, Microbial; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Infant; Male; Nasopharynx; Otitis Media with Effusion; Penicillin V; Penicillins; Recurrence; Treatment Outcome

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Clavulanic Acids; Drug Therapy, Combination; Family Practice; Humans; Otitis Media with Effusion; Randomized Controlled Trials as Topic; Treatment Outcome

To compare the effect of 2 different antimicrobial agents in the treatment of secretory otitis media (SOM).. Prospective, double-blind, randomized study.. From a pool of 1450 children (aged 1-10 years) with SOM, defined by tympanometry as having type B or C2 tympanograms, 429 with SOM of at least 3 months' duration were included in the trial. After exclusion of 69 patients, the remaining 360 were evenly distributed among 4 treatment groups: penicillin V (Primcillin) for 14 and 28 days, and amoxicillin and clavulanate potassium in combination (Spektramox) for 14 and 28 days. Criteria for improvement was a change in tympanometric findings to type C1 or type A.. The success rates were in favor of amoxicillin-clavulanate treatment for 28 days (P < .001) (rates for respective 14- and 28-day groups: penicillin V, 23% and 19%; amoxicillin-clavulanate, 31% and 44%). Antimicrobial therapy was more efficient (P < .001) in unilateral vs bilateral disease.. Antibiotic treatment improves the middle ear status in patients with SOM, and amoxicillin-clavulanate provides superior improvement to penicillin V.

Topics: Acoustic Impedance Tests; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Otitis Media with Effusion; Patient Selection; Penicillin V; Remission Induction; Time Factors

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Combined Modality Therapy; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media with Effusion; Otitis Media, Suppurative; Penicillins; Treatment Outcome

The treatment of persistent otitis media with effusion (OME) remains controversial, but this condition is the commonest reason for children to require ear, nose, and throat (ENT) surgery. Trials of antibiotics are inconclusive, are often weak methodologically, and have not been done in general practice. Our aim was a trial of an antibiotic for OME in such a population.. 433 children, aged 6 months to 6 years, with OME from 57 general practices entered a 3-month watchful waiting period. Of 223 (52%) with persistent bilateral OME, 162 were randomised double-blind to receive co-amoxiclav suspension (20 mg/kg amoxicillin, 5 mg/kg clavulanate potassium) or matching placebo, orally three times a day for 14 days. All cases also received xylometazoline 0.25% decongestant nosedrops thrice daily. Of the 61 not randomised, 13 children were referred to an ENT surgeon and parents refused consent in 48 cases. The main outcome measures were persistent OME in both ears and in one or both ears, as assessed clinically and by tympanometry. Analysis was by intention-to-treat.. 79 children in the treatment group and 70 in the placebo group were analysed for efficacy. 3 withdrew in the co-amoxiclav group (2 lost to follow-up, 1 due to side-effects); 6 withdrew in the placebo group (5 and 1, respectively). In addition, 4 tympanograms were uninterpretable in the controls. Compliance was over 90% in both groups. Persistent OME in both ears and in one or both ears were found at significantly lower rates in the co-amoxiclav group than in the controls at the 2-week follow-up: 53 vs 84% and 77 vs 93%, respectively. Odds ratios adjusted for sex, history of adenoidectomy, and upper respiratory tract infection at follow-up were 0.25 (95% CI 0.11, 0.58, p = 0.001) and 0.30 (0.10, 0.89, p = 0.03), respectively. Parents of children in the co-amoxiclav group reported significantly more side-effects than those of control children (44 vs 22%, p = 0.03). Side-effects were mostly gastrointestinal and mild.. Our study in a general-practice setting confirmed the positive short-term effect of antibiotic treatment for persistent middle-ear infection. Before referral to an ENT surgeon, children with persistent OME presenting to general practitioners could be considered for such treatment, depending on the individual child and possible adverse sequelae.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Infant; Male; Multivariate Analysis; Odds Ratio; Otitis Media with Effusion; Placebos; Treatment Outcome

The efficacy and safety of ceftibuten (9 mg/kg daily for 10 days) were compared with those of amoxicillin/clavulanate (Augmentin 40 mg/kg/day given every 8 hours for 10 days) in the empiric treatment of acute otitis media in children. This was a multicenter, investigator-blinded study with 1:1 randomization. Overall clinical response and signs and symptoms of otitis were collected prospectively pretreatment, 3 to 5 days during treatment, 1 to 3 days post-treatment and at 2- to 4-week follow-up. In addition to spontaneous reports of other adverse events, gastrointestinal adverse events were prospectively elicited at each visit. Two hundred ninety-six patients (146 ceftibuten and 150 amoxicillin/clavulanate) were treated with at least 1 dose of study medication. Compliance with dosing was assessable with weight of drug consumed in 127 patients in each treatment group. Five percent (6 of 127) of ceftibuten patients and 11% (14 of 127) of amoxicillin/clavulanate patients received < 80% of prescribed drug (P = 0.10) and were therefore not valid. Two hundred twenty-two patients (121 ceftibuten and 101 amoxicillin/clavulanate) received a minimum of 80% of prescribed medication and were compliant with the protocol. Ceftibuten and amoxicillin/clavulanate groups were comparable both for demographic variables and for baseline signs and symptoms.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ceftibuten; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media with Effusion; Patient Compliance; Treatment Outcome

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

Two hundred sixty-three pediatric patients from the ages of 3 months to 11 years were enrolled in a randomized, investigator-blinded, multicenter study comparing the clinical and bacteriological efficacies and safety of cefuroxime axetil suspension (CAE) with those of amoxicillin-clavulanate suspension (AMX-CL) in the treatment of acute otitis media with effusion. Patients received CAE at 30 mg/kg of body weight per day (n = 165) in two divided doses or AMX-CL at 40 mg/kg/day (n = 98) in three divided doses for 10 days. The primary pathogens among 200 isolates from pretreatment cultures of middle ear fluid were identified as follows: Haemophilus influenzae (39%), over a third of which were beta-lactamase positive; Streptococcus pneumoniae (34%); and Moraxella catarrhalis (16%). Pathogens were eradicated or presumed to be eradicated from 81% (95 of 118) and 76% (50 of 66) of bacteriologically evaluable patients in the CAE and AMX-CL groups, respectively. A satisfactory clinical response (cure or improvement with or without resolution of effusion) occurred in 113 (77%) of 146 clinically evaluable patients in the CAE group and in 66 (74%) of 89 evaluable patients in the AMX-CL group. Clinical failure or recurrence (within 2 weeks following the completion of treatment) occurred in 22 and 26% of CAE- and AMX-CL-treated patients, respectively. Drug-related adverse events occurred in 18% of CAE-treated patients, whereas they occurred in 39% of AMX-CL-treated patients (P < 0.001); diarrhea or loose stools was the most commonly reported adverse event (CAE, 12%; AMX-CL, 31%; P < 0.001). These results indicate that CAE given twice daily is as effective as AMX-CL given three times daily in the treatment of acute otitis media with effusion in pediatric patients, but CAE was associated with significantly fewer drug-related adverse events.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefuroxime; Child; Child, Preschool; Clavulanic Acids; Female; Humans; Infant; Male; Otitis Media with Effusion; Prodrugs; Suspensions

The efficacy and safety of loracarbef, a new beta-lactam antibiotic, was compared with that of amoxicillin-clavulanate potassium in the treatment of bacterial acute otitis media with effusion. A double-blind format was utilized to administer 10-day, randomized, parallel treatment regimens to patients who were between 6 months and 12 years of age. The most prevalent causative pathogens found in the two treatment groups were Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella (Branhamella) catarrhalis. The percentages of favorable posttherapy clinical responses in evaluable patients were similar for both drugs: 87.3% (124/142) of the loracarbef group, compared with 91.5% (130/142) of the amoxicillin-clavulanate group, showed favorable responses within 72 hours after treatment. Ten to sixteen days after treatment, 68.1% of the loracarbef group, compared with 76.1% of the amoxicillin-clavulanate group, showed favorable responses. More patients in the amoxicillin-clavulanate group reported treatment-emergent events: 46.1% compared with 35.8% in the loracarbef group (p = 0.023). Diarrhea was the most frequently reported event, occurring in 13.3% of the loracarbef group and in 26.3% of the amoxicillin-clavulanate group (p less than 0.001). Vomiting was reported by 5.8% of the loracarbef group and 10.3% of the amoxicillin-clavulanate group (p = 0.072). Loracarbef is comparable in efficacy to amoxicillin-clavulanate in the treatment of bacterial acute otitis media with effusion and has a more desirable safety profile.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cephalosporins; Clavulanic Acids; Double-Blind Method; Drug Evaluation; Drug Therapy, Combination; Female; Haemophilus influenzae; Humans; Infant; Male; Moraxella catarrhalis; Otitis Media with Effusion; Streptococcus pneumoniae

In two randomized clinical trials in children with otitis media, the efficacy and safety of cefprozil are compared to those of amoxicillin/clavulanate (n = 530) and of cefaclor and cefixime (n = 394). The rate of clinical cure or improvement was similar among patients receiving each drug regimen, ranging from 78% for amoxicillin/clavulanate to 89% for cefaclor; for cefprozil, this rate was 84% and 85% in the two studies, respectively. In the first study, cefprozil was superior to amoxicillin/clavulanate in the satisfactory clinical response rate for Streptococcus pneumoniae (P = .049), but response rates were similar for Haemophilus influenzae and Moraxella catarrhalis. Significantly more patients treated with amoxicillin/clavulanate (P less than .001) in the first study or cefixime (P less than .01) in the second study developed diarrhea than did those treated with cefprozil. We conclude that cefprozil therapy for otitis media in children produces clinical and bacteriologic response rates similar to those seen with amoxicillin/clavulanate, cefixime, or cefaclor. Furthermore, diarrhea was significantly less common with cefprozil than with cefixime or amoxicillin/clavulanate.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Cefaclor; Cefixime; Cefotaxime; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Humans; Infant; Otitis Media with Effusion

A total of 137 children with acute otitis media with effusion were randomly allocated to treatment with cefprozil (30 mg/kg/day divided into two equal doses), an investigational cephalosporin or amoxicillin clavulanate potassium (40 mg/kg/day divided into three equal doses) for 10 days. The most common pathogens obtained from middle ear cavities by tympanocentesis were Streptococcus pneumoniae (33%), Haemophilus influenzae (19.6%) and Moraxella catarrhalis (8.3%). Patients were scheduled for follow-up visits at midtreatment, at end of therapy and at 30 days. Of the 137 children 122 were evaluable. Five of 60 patients (8.3%) treated with cefprozil and 14 of 62 patients (22.5%) treated with amoxicillin clavulanate potassium were considered therapeutic failures because of persistence of symptoms and/or isolation of the original pathogen or superinfection (P = 0.05). Rates of relapse, reinfection and persistent middle ear effusion as documented by tympanogram were comparable in both groups. When persistent middle ear effusion was analyzed by pneumatic otoscopy, 64 of 103 affected ears (62.1%) treated with cefprozil and 80 of 105 affected ears (76.1%) treated with amoxicillin clavulanate potassium were abnormal (P = 0.04). Loose stools were more common in children treated with amoxicillin clavulanate potassium than in children treated with cefprozil (P = 0.0004). Based on the efficacy results from this study, the lower gastrointestinal side effects and the convenience of twice-a-day dosing, we believe that cefprozil in a dosage of 30 mg/kg/day divided every 12 hours represents a potential alternative for the treatment of acute otitis media with effusion in children.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Haemophilus influenzae; Humans; Infant; Moraxella catarrhalis; Otitis Media with Effusion; Recurrence; Streptococcus pneumoniae

There are various forms of medical treatment for otitis media with effusion (OME) in children. One of these is a four week course of an antibiotic. A trial was carried out comparing cotrimoxazole with amoxicillin-potassium clavulanate in 102 cases with 181 affected ears. In addition this trial used various procedures to increase and monitor compliance, and the results showed that the compliant cases did much better than the noncompliant cases and cotrimoxazole was more effective than amoxicillin-potassium clavulanate. When the ethnic groupings were analysed the compliance was lower for the Maori (24%) and Pacific Islander (29%) than the European (49%). The success rate for the compliant cases whose middle ear effusion resolved in one or both ears had a similar result with Maori (40%), Pacific Islander (60%) and European (71%) probably indicating an increased nonmeasured compliance in the latter.

Topics: Age Factors; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Chi-Square Distribution; Child; Child, Preschool; Chronic Disease; Clavulanic Acids; Drug Administration Schedule; Female; Humans; Infant; Male; New Zealand; Otitis Media with Effusion; Patient Compliance; Trimethoprim, Sulfamethoxazole Drug Combination

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Clavulanic Acids; Clinical Trials as Topic; Humans; Otitis Media with Effusion; Reproducibility of Results

In a prospective study, 105 infants aged 3-12 months with acute otitis media were randomly assigned to one of three treatment groups: amoxycillin/clavulanate ('Augmentin') alone (36 patients), myringotomy plus placebo (35 patients), or augmentin plus myringotomy (34 patients). The last two groups were double-blinded. Bacterial pathogens, mainly Haemophilus influenzae (of which 20% were beta-lactamase producers) and Streptococcus pneumoniae, were isolated from 60% of the ear exudates and all isolates were sensitive to augmentin. Most of the infants improved clinically within 3-6 days irrespective of the treatment protocol. As judged by otoscopy, 60% of the patients receiving augmentin, with or without myringotomy, recovered completely compared with 23% of patients treated with myringotomy plus placebo. Treatment with augmentin was also more effective than myringotomy with regard to persistence of ear infection. In the myringotomy plus augmentin group closure of the incision and resolution of the discharge from the incision site was faster than in the myringotomy plus placebo group. The addition of myringotomy to augmentin did not seem to affect either the persistence of the infection after treatment or the residual middle ear effusion.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Clavulanic Acids; Clinical Trials as Topic; Combined Modality Therapy; Diarrhea; Double-Blind Method; Drug Administration Schedule; Evaluation Studies as Topic; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media with Effusion; Prospective Studies; Random Allocation; Time Factors; Tympanic Membrane

A double-blind, randomized, placebo-controlled clinical trial was conducted to evaluate one month of amoxicillin-clavulanate potassium treatment of children with secretory otitis media. In total, 264 children, aged 1 to 10 years, were randomly assigned to either antibiotic or placebo treatment; 43 patients were excluded during treatment, equally distributed in both groups, leaving 221 patients completing the trial. The inclusion criterion was a type C2 and type B tympanometry result of at least three months' duration. Tympanometry was performed every month for 12 additional months. At the end of the treatment period, the disease was reversed in 61% in the antibiotic-treated group compared with 30% in the placebo-treated group (P less than .0001), and the improvement was persistently significant in favor of antibiotic for eight months. The effect was present in all age groups and independent of laterality of disease. The middle-ear status at the end of treatment was the determining factor for the outcome of tympanometry the year following treatment. From the end of treatment, there was no difference between tympanometry in a patient having been treated with the antibiotic and a patient having been treated with placebo. Antibiotic treatment shifts the individual patient from poor to better tympanometric conditions, so antibiotics can be recommended in the treatment of secretory otitis media before inserting ventilating tubes.

Topics: Acoustic Impedance Tests; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Clinical Trials as Topic; Double-Blind Method; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media with Effusion; Random Allocation; Time Factors

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Clavulanic Acids; Clinical Trials as Topic; Double-Blind Method; Drug Therapy, Combination; Humans; Otitis Media with Effusion; Placebos; Time Factors

A double-blind randomized clinical trial was conducted at two sites comparing amoxicillin-clavulanate potassium (Augmentin) and amoxicillin trihydrate for the treatment of otitis media with effusion ("secretory otitis media"). One hundred eight subjects were randomly assigned to receive a ten-day course of either drug regimen. Clinical response was assessed at ten days and four weeks after entry. For those without middle ear effusion at four weeks, recurrence rates were measured at 8, 12, and 16 weeks after entry. At ten days following entry, 29 (51.8%) of 56 subjects in the amoxicillin-clavulanate-treated group were effusion free compared with 16 (32.0%) of 50 subjects in the amoxicillin-treated group (P = .06). At four weeks following entry, 26 (50.0%) of 50 subjects in the amoxicillin-clavulanate-treated group were effusion free compared with 23 (51.1%) of 45 subjects in the group given amoxicillin. By the 16-week visit, eight (36.4%) of 22 subjects in the amoxicillin-clavulanate-treated group who were effusion free at four weeks had recurrence of effusion, compared with 12 (63.2%) of 19 subjects in the amoxicillin-treated group. This study suggests that there was a favorable clinical response immediately following treatment in the amoxicillin-clavulanate--treated subjects as compared with those treated with amoxicillin, but this benefit was not sustained at the four-week end point.

Topics: Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media with Effusion; Patient Compliance; Random Allocation; 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

Alloiococcus otitidis is a slow growing organism which has been isolated in a few studies on patients with otitis media with effusion (OME). According to the literature review, there is no study about the molecular typing of A. otitidis. In this study, the characteristics of A. otitidis isolates from patients with OME were investigated via Pulsed-Field Gel Electrophoresis (PFGE) typing method.. A total of 50 children with OME, who underwent myringotomy or who had an insertion of a ventilation tube, were included in this study. The isolates were identified to the species level as A. otitidis using standard biochemical methods, following which the amplification and sequencing of the 16S rRNA gene were carried out. The molecular characteristic of A. otitidis was investigated by PFGE technique.. Fifteen isolates of A. otitidis were identified in the middle ear fluid of the patients. All the isolates were susceptible to ampicillin, amoxicillin/clavulanate and fluoroquinolones. All of the 15 isolates were typed by PFGE method and were found to include 13 different PFGE types.. The current study, being the first reports on the molecular typing of A. otitidis by PFGE method, shows that A. otitidis is a heterogenic organism in Iranian children who have OME.

Topics: Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Anti-Bacterial Agents; Child; Child, Preschool; Electrophoresis, Gel, Pulsed-Field; Female; Fluoroquinolones; Gram-Positive Bacteria; Gram-Positive Bacterial Infections; Humans; Male; Middle Ear Ventilation; Otitis Media with Effusion; RNA, Ribosomal, 16S

In non-randomized clinical studies, the regression phenomenon can confound interpretation of the effectiveness of an intervention. The regression effect arises due to daily variation and/or misclassification of the biologic marker used in selection as well as in the assessment of the intervention effect. We consider a scenario in which the selection criterion for a subject's participation in the study is such that he/she must have a positive diagnostic test at screening. The disease status is then reassessed at the end of intervention. Thus, two repeated measurements of a binary disease outcome are available, with only selected subjects having a second measurement upon follow-up. We propose methods for estimating the change in event probability resulting from implementing the intervention while adjusting for the misclassification that produces the regression effect. We extend this approach to estimation of both the placebo and intervention effects in placebo-controlled studies designed with a misclassified binary outcome. Analyses of two biomedical studies are used for illustration.

Topics: Acoustic Impedance Tests; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Bias; Cefdinir; Cephalosporins; Child; Child, Preschool; Clinical Trials as Topic; Computer Simulation; Diagnostic Errors; Humans; Infant; Otitis Media with Effusion; Treatment Outcome

We raise the concern of whether the use of a placebo group in a randomized clinical trial is sufficient to eliminate bias in the assessment of the effectiveness of a drug when enrollment into the trial prior to intervention requires diagnosis of a dichotomous disease, and the diagnostic test is subject to uncertainty. Due to misclassification and the regression effect, the observed difference in the proportions of diseased individuals between the treatment and placebo groups at follow-up will be equal to the true difference multiplied by the positive predictive value at screening and the difference between the sensitivity and the false-positive value at follow-up. Thus, measurement error of disease status before and after administering the intervention attenuates the intervention effect. Validation data corresponding to both the screening and follow-up conditions are necessary to provide additional information on the validity of the diagnostic test. Proper statistical analysis should include such data for an accurate portrayal of the effectiveness of the treatment.

Topics: Amoxicillin-Potassium Clavulanate Combination; Bias; Comorbidity; Data Collection; Double-Blind Method; Drug Therapy, Combination; Health Status; Humans; Otitis Media with Effusion; Randomized Controlled Trials as Topic; Regression Analysis; Reproducibility of Results; Treatment Outcome

Sparse recent data are available in the United States regarding the pathogens of acute otitis media (AOM) most likely to be recovered from children recently treated with the two most frequently prescribed antibiotics, amoxicillin or amoxicillin/clavulanate (AMC).. Of the 704 rural Kentucky children with culture-positive AOM who underwent a single tympanocentesis or culture of otorrhea between 1992 and 1998, 96 pathogens were recovered from 90 children during therapy or within 7 days posttherapy with an aminopenicillin. Identification and susceptibility testing of AOM pathogens were performed by routine National Committee for Clinical Laboratory Standards methods.. Pathogens recovered from children with AOM recently treated (0 to 7 days) with amoxicillin (n = 38) and AMC (n = 58), respectively, were as follows: Haemophilus influenzae (beta-lactamase-negative), 16 and 29%; H. influenzae (beta-lactamase-positive), 11 and 22%; penicillin-susceptible Streptococcus pneumoniae, 26 and 12%; intermediately penicillin-nonsusceptible S. pneumoniae (PNSP), 20 and 10%; resistant PNSP 13 and 17%; Moraxella catarrhalis (beta-lactamase-positive), 13 and 7%; and Streptococcus pyogenes, 3 and 2%. H. influenzae was also isolated from 8 (75%) of 12 children treated with high dose AMC ( approximately 80 mg/kg/day amoxicillin component). Significantly fewer children recently treated with amoxicillin were otitis-prone than those given AMC (24% vs. 74%, P < 0.0001).. The predominant pathogen recovered from children with AOM recently treated with amoxicillin was S. pneumoniae (59%) rather than beta-lactamase-producing organisms (24%). H. influenzae was the predominant (51%) pathogen, rather than PNSP (27%), recovered from children recently treated with AMC.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; beta-Lactam Resistance; Child; Child, Preschool; Drug Resistance, Multiple, Bacterial; Drug Therapy, Combination; Female; Haemophilus influenzae; Humans; Infant; Male; Microbial Sensitivity Tests; Moraxella catarrhalis; Otitis Media with Effusion; Penicillins; Retrospective Studies; Streptococcus pneumoniae; Streptococcus pyogenes

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

A gerbil model of otitis media induced by a beta-lactamase producing and non-serotypeable isolate of Haemophilus influenzae was used to assess the in-vivo efficacy of co-amoxiclav and cefuroxime at low (5 mg/kg) and high (20 mg/kg) doses. The MIC of the antibiotics tested against the pathogen was 1 mg/L (1/0.5 mg/L for co-amoxiclav). The organism was inoculated (+/-10(6) cfu) by transbullar challenge directly in the middle ear and antibiotic treatment was commenced 2 h post-inoculation and continued at 8 h intervals for three doses. Only high dose co-amoxiclav significantly reduced the number of culture-positive specimens as compared with untreated animals or with other treatment groups (91.7% as compared with 36.7% for high dose cefuroxime). The results obtained in any treatment group were related to middle ear antibiotic level/MIC. Antibiotic concentrations in the middle ear 90 min after administration were about 10% of serum levels at 15 min, probably related to a slight inflammatory response. Only after high dose co-amoxiclav did the concentration in the middle ear exceed the MIC by a factor of four. In otitis media with effusion, if indicated, antibiotics active in vitro should be administered in high doses and, to avoid side effects, probably in short courses.

Topics: Amoxicillin-Potassium Clavulanate Combination; Animals; beta-Lactamases; Cefuroxime; Cephalosporins; Disease Models, Animal; Drug Therapy, Combination; Female; Gerbillinae; Haemophilus Infections; Haemophilus influenzae; Humans; Microbial Sensitivity Tests; Otitis Media with Effusion; Treatment Outcome

One thousand one hundred and sixty-four patients formed the pool of patients from which we intended to recruit children to a controlled trial evaluating the efficacy of amoxicillin-clavulanate and penicillin-V in the treatment of secretory otitis media (SOM). Only 360 patients ended up to be evaluated, consisting only 30% of the primarily involved patients. The spontaneous improvement of the tympanometric condition was the major course of pre-trial dropouts. The demographic composition of included and excluded patients did not differ, as one might have expected. Very little has previously been published about this great number of excluded patients even though other authors must have had the same experience. It is concluded that a 3-month duration of SOM, evaluated by tympanometry by the investigators, is required as a minimum to qualify for entering a trial evaluating SOM.

Topics: Acoustic Impedance Tests; Amoxicillin-Potassium Clavulanate Combination; Child, Preschool; Double-Blind Method; Female; Humans; Infant; Male; Otitis Media with Effusion; Patient Dropouts; Patient Selection; Penicillin V; Randomized Controlled Trials as Topic

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: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Drug Therapy, Combination; Humans; Infant; Otitis Media with Effusion; Penicillins

The objective of this study was to determine the prevalence of bacteria isolated from middle ear effusions in infants with otitis media in our environment. Data collected from 50 patients of the Infant Section of the Unidad Integrada Hospital Clínico-San Juan de Dios were evaluated prospectively from October 1, 1992 to March 7, 1994. Patients between 1 month and 1 year of age, with unilateral or bilateral otitis media diagnosed by otoscopy criteria and positive myringotomy, were recruited for study. Those who had received any antibiotic during the previous 3 days or had been admitted to the hospital more than 5 days before were excluded. We found that failure to thrive (18%) is a common form of onset of otitis media in children under one year of age. Rhinorrhea and nasal obstruction (60%), cough (50%) and fever (46%) were the most frequent symptoms at the moment of diagnosis. Blood analysis does not add any information for diagnosing otitis media. The difference between acute otitis media and otitis media with effusion is likely to be more clinical rather than microbiological. The recovery of pathogens from 62% of the ear cultures correlates with the figures reported in the literature. The predominance of S. pneumoniae (38%), followed by H. influenzae (25%), is in agreement with previous findings internationally. In our study, there is no evidence of viruses alone causing otitis media in infants. Consequently, antibiotic therapy should be indicated in every child with otitis media.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteria; Clavulanic Acids; Drug Therapy, Combination; Ear, Middle; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media with Effusion; Prospective Studies

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acids; Drug Therapy, Combination; Humans; Otitis Media with Effusion