cefdinir 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

Given the relatively high prevalence of recurrent and persistent acute otitis media (AOM) and the prominent etiologic role of Streptococcus pneumoniae, especially penicillin-nonsusceptible strains in children with these conditions, new alternative treatments are desirable.. Children 6 months-4 years of age with AOM considered to be at risk for recurrent or persistent infection received large dosage cefdinir 25 mg/kg oral suspension once daily for 10 days. Children were evaluated pretreatment (day 1), on therapy (days 4-6), end of therapy (days 12-14) and at follow-up (days 25-28). All children had tympanocentesis at enrollment. In culture-positive children, tympanocentesis was repeated after 3-5 days (days 4-6) unless evidence of absence of middle ear effusion was documented.. Of 447 children enrolled, 230 were clinically and bacteriologically evaluable (74% 2 years old or younger; 57% treated for AOM in previous 3 months). Bacteriologic eradication, based on repeat tympanocentesis on days 4-6, was achieved in 74% (170 of 230) of children; 76% (201 of 266) of AOM pathogens were eradicated. Eradication of penicillin-susceptible, -intermediate and -resistant S. pneumoniae was 91% (50 of 55), 67% (18 of 27) and 43% (10 of 23), respectively (P < 0.001); eradication of H. influenzae was 72% (90 of 125). Overall clinical response at days 12-14 was 83% (76 and 82% for children with S. pneumoniae and Haemophilus influenzae, respectively). Sustained clinical response at days 25-28 was 85%. Clinical response was 83% for culture-positive children versus 96% for culture-negative children at baseline tympanocentesis (P < 0.001).. In this study of AOM among children at risk for persistent or recurrent infection, large dose cefdinir resulted in an overall successful clinical response at end of treatment of 83%. This regimen was efficacious against penicillin-susceptible S. pneumoniae, but effectiveness was markedly decreased against nonsusceptible strains and was moderate for H. influenzae strains.

Topics: Acute Disease; Administration, Oral; Anti-Infective Agents; Cefdinir; Cephalosporins; Child, Preschool; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Otitis Media with Effusion; Paracentesis; Penicillin Resistance; Pneumococcal Infections; Recurrence; Risk Factors; Streptococcus pneumoniae; Treatment Outcome

To examine the microbiologic and clinical efficacy of a 5-day course of cefdinir in the treatment of tympanocentesis-documented acute otitis media (AOM).. Open label noncomparative trial.. Primary care, ambulatory.. Children ages 6 months through 12 years with signs of AOM and middle ear effusion confirmed by tympanometry in at least one ear.. Patients underwent tympanocentesis at baseline and received cefdinir 7 mg/kg twice a day for 5 days.. Presumptive eradication of middle ear pathogens determined by clinical cure of signs and symptoms of AOM at end of therapy (Study Days 7 to 9) and Visit 3 (Study Days 16 to 21).. A total of 125 of 177 enrolled children had 134 pathogens isolated by tympanocentesis: Streptococcus pneumoniae, 69 (51.5%); Haemophilus influenzae 44 (32.8%; beta-lactamase-positive in 18 of 44 strains); beta-lactamase-positive Moraxella catarrhalis, 15 (11.2%); and Streptococcus pyogenes, 6 (4.5%). The clinical cure rates by patient in the microbiologically and overall clinically evaluable groups, respectively, were 73% (84 of 115) and 77.4% (130 of 168) at the end of therapy visit and 57.4% (66 of 115) and 61.9% (104 of 168) at Visit 3. Presumptive eradication rates at end of therapy were 8 of 11 (72.7%) and 4 of 8 (50%) for patients with penicillin-intermediate and -resistant S. pneumoniae isolates, respectively. Adverse reactions occurred in 16% of patients, with diarrhea (11%) occurring most frequently.. A 5-day regimen of cefdinir was effective in the eradication of the common causative pathogens of nonrefractory AOM, including intermediate penicillin-resistant S. pneumoniae and beta-lactamase-producing organisms. Cefdinir should be considered a suitable second line antibiotic for AOM.

Topics: Acoustic Impedance Tests; Acute Disease; Bacterial Infections; Cefdinir; Cephalosporins; Child; Child, Preschool; Female; Haemophilus influenzae; Humans; Infant; Male; Microbial Sensitivity Tests; Moraxella catarrhalis; Otitis Media; Otitis Media with Effusion; Penicillin Resistance; Streptococcus pneumoniae; Streptococcus pyogenes; Treatment Outcome

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

To compare the effects of cefdinir (14 mg/kg per day) and amoxicillin (90 mg/kg per day) antimicrobial therapy on the nasopharyngeal flora of children with acute otitis media.. Nasopharyngeal cultures for aerobic and facultative bacteria were obtained before therapy and 2 to 4 days after completion of therapy.. Outpatient clinic.. Fifty children, aged 7 months to 5 years 4 months.. After completion of therapy, 22 (88%) of the 25 patients treated with cefdinir and 16 (64%) of the 25 patients treated with amoxicillin were considered clinically cured (P<.05). A significant reduction in the number of all isolates occurred following therapy in those treated with cefdinir (36 vs 71, P<.01) or with amoxicillin (56 vs 73, P<.05). However, the total number of isolates recovered after therapy was significantly lower in those treated with cefdinir (36) compared with those treated with amoxicillin (56) (P<.01).. The recovery of potential pathogenic organisms (eg, Streptococcus pneumoniae, Staphylococcus aureus, beta-hemolytic streptococci, Haemophilus species, and Moraxella catarrhalis), as well as penicillin-resistant bacteria, was lower following completion of therapy in the cefdinir group (6 pathogens, including 5 that were penicillin resistant), compared with the amoxicillin group (27 pathogens, including 16 that were penicillin resistant) (P<.01).. This study illustrates the greater ability of cefdinir compared with amoxicillin to reduce the number of potential nasopharyngeal pathogens as well as penicillin-resistant bacteria in children with acute otitis media.

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents; Bacteria; Cefdinir; Cephalosporins; Child, Preschool; Female; Follow-Up Studies; Humans; Infant; Infant, Newborn; Male; Nasopharynx; Otitis Media with Effusion; Retrospective Studies; Treatment Outcome