The clinical course of acute otitis media in high-risk Australian Aboriginal children: a longitudinal study

BACKGROUND: It is unclear why some children with acute otitis media (AOM) have poor outcomes. Our aim was to describe the clinical course of AOM and the associated bacterial nasopharyngeal colonisation in a high-risk population of Australian Aboriginal children. METHODS: We examined Aboriginal children younger than eight years who had a clinical diagnosis of AOM. Pneumatic otoscopy and video-otoscopy of the tympanic membrane (TM) and tympanometry was done every weekday if possible. We followed children for either two weeks (AOM without perforation), or three weeks (AOM with perforation), or for longer periods if the infection persisted. Nasopharyngeal swabs were taken at study entry and then weekly. RESULTS: We enrolled 31 children and conducted a total of 219 assessments. Most children had bulging of the TM or recent middle ear discharge at diagnosis. Persistent signs of suppurative OM (without ear pain) were present in most children 7 days (23/30, 77%), and 14 days (20/26, 77%) later. Episodes of AOM did not usually have a sudden onset or short duration. Six of the 14 children with fresh discharge in their ear canal had an intact or functionally intact TM. Perforation size generally remained very small (<2% of the TM). Healing followed by re-perforation was common. Ninety-three nasophyngeal swabs were taken. Most swabs cultured Streptococcus pneumoniae (82%), Haemophilus influenzae (71%), and Moraxella catarrhalis (95%); 63% of swabs cultured all three pathogens. CONCLUSION: In this high-risk population, AOM was generally painless and persistent. These infections were associated with persistent bacterial colonisation of the nasopharynx and any benefits of antibiotics were modest at best. Systematic follow up with careful examination and review of treatment are required and clinical resolution cannot be assumed

Antibiotics for acute otitis media: a meta-analysis with individual patient data.

BACKGROUND: Individual trials to test effectiveness of antibiotics in children with acute otitis media have been too small for valid subgroup analyses. We aimed to identify subgroups of children who would and would not benefit more than others from treatment with antibiotics. METHODS: We did a meta-analysis of data from six randomised trials of the effects of antibiotics in children with acute otitis media. Individual patient data from 1643 children aged from 6 months to 12 years were validated and re-analysed. We defined the primary outcome as an extended course of acute otitis media, consisting of pain, fever, or both at 3-7 days. FINDINGS: Significant effect modifications were noted for otorrhoea, and for age and bilateral acute otitis media. In children younger than 2 years of age with bilateral acute otitis media, 55% of controls and 30% on antibiotics still had pain, fever, or both at 3-7 days, with a rate difference between these groups of -25% (95% CI -36% to -14%), resulting in a number-needed-to-treat (NNT) of four children. We identified no significant differences for age alone. In children with otorrhoea the rate difference and NNT, respectively, were -36% (-53% to -19%) and three, whereas in children without otorrhoea the equivalent values were -14% (-23% to -5%) and eight. INTERPRETATION: Antibiotics seem to be most beneficial in children younger than 2 years of age with bilateral acute otitis media, and in children with both acute otitis media and otorrhoea. For most other children with mild disease an observational policy seems justified

Antibiotic therapy to prevent the development of asymptomatic middle ear effusion in children with acute otitis media: a meta-analysis of individual patient data.

OBJECTIVES: To determine predictors of the development of asymptomatic middle ear effusion (MEE) in children with acute otitis media (AOM) and to assess the effect of antibiotic therapy in preventing the development of MEE in these children. DATA SOURCES: A systematic literature search was performed using PubMed, EMBASE, the Cochrane databases, and the proceedings of international otitis media symposia. STUDY SELECTION: A trial was selected if the allocation of participants to treatment was randomized, children aged 0 to 12 years with AOM were included, the comparison was between antibiotic therapy and placebo or no (antibiotic) treatment, and MEE at 1 month was measured. DATA EXTRACTION: Data from 5 randomized controlled trials were included in the meta-analysis of individual patient data (1328 children aged 6 months to 12 years). We identified independent predictors of the development of asymptomatic MEE and studied whether these children benefited more from antibiotic therapy than children with a lower risk. The primary outcome was MEE (defined as a type B tympanogram) at 1 month. DATA SYNTHESIS: The overall relative risk of antibiotic therapy in preventing the development of asymptomatic MEE after 1 month was 0.9 (95% confidence interval, 0.8-1.0; P =.19). Independent predictors of the development of asymptomatic MEE were age younger than 2 years and recurrent AOM. No statistically significant interaction effects with treatment were found. CONCLUSION: Because of a marginal effect of antibiotic therapy on the development of asymptomatic MEE and the known negative effects of prescribing antibiotics, including the development of antibiotic resistance and adverse effects, we do not recommend prescribing antibiotics to prevent MEE

Predictors of pain and/or fever at 3 to 7 days for children with acute otitis media not treated initially with antibiotics: a meta-analysis of individual patient data.

OBJECTIVE: The goal was to determine the predictors of a prolonged course for children with acute otitis media. METHODS: A meta-analysis of data with the observation groups of 6 randomized, controlled trials was performed. Participants were 824 children, 6 months to 12 years of age, with acute otitis media. The primary outcome was a prolonged course of acute otitis media, which was defined as fever and/or pain at 3 to 7 days. RESULTS: Of the 824 included children, 303 had pain and/or fever at 3 to 7 days. Independent predictors of a prolonged course were age of or = 2 years of age with unilateral acute otitis media (47% of all children) was 25%. CONCLUSIONS: The risk of a prolonged course was 2 times higher for children or = 2 years of age with unilateral acute otitis media. Clinicians can use these features (ie, age of < 2 years and bilateral acute otitis media) to inform parents more explicitly about the expected course of their child's otitis media and to explain which features should prompt parents to contact their clinician for reexamination of the child

Treatment of acute otitis media in children under 2 years of age

Background: Recommendations vary regarding immediate antimicrobial treatment versus watchful waiting for children younger than 2 years of age with acute otitis media. Methods: 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. Results: 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. Conclusions: 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.) Copyright © 2011 Massachusetts Medical Society