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.).
We observed an intense enterovirus D68 outbreak in children in southwest Finland in August-September 2022. We confirmed enterovirus D68 infection in 56 children hospitalized for respiratory illnesses ...and in 1 child with encephalitis but were not able to test all suspected patients. Continuing surveillance for enterovirus D68 is needed.
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.
This is a secondary analysis of randomized, double-blind, placebo-controlled trial. Children 6 to 35 months of age with AOM
319) were randomly allocated to receive amoxicillin-clavulanate (40/5.7 mg/kg per day) or placebo for 7 days. Our primary outcome was time until treatment failure.
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;
= .04; and hazard ratio, 0.43; 95% CI, 0.21 to 0.88;
= .02, respectively). The rate difference for treatment failure between antimicrobial treatment and placebo groups was highest among children with severe bulging of the tympanic membrane (11.1% vs 64.1%; rate difference -53.0%; 95% CI, -73.5% to -32.4%), resulting in a number needed to treat of 1.9.
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.
Despite concerns that antimicrobial treatment of prevalent infections may select for drug-resistant bacteria, the effects of antimicrobial treatment on colonization dynamics have not been well ...quantified.
We measured impacts of antimicrobial treatment on nasopharyngeal carriage of penicillin-susceptible Streptococcus pneumoniae (PSSP) and penicillin-nonsusceptible (PNSP) lineages at the end of treatment and 15, 30, and 60 days after treatment in a previously conducted randomized, double-blinded, placebo-controlled trial of amoxicillin-clavulanate for stringently defined acute otitis media.
In intention-to-treat analyses, immediate treatment with amoxicillin-clavulanate reduced PSSP carriage prevalence by 88% (95% confidence interval CI, 76%-96%) at the end of treatment and by 27% (-3%-49%) after 60 days but did not alter PNSP carriage prevalence. By the end of treatment, 7% of children who carried PSSP at enrollment remained colonized in the amoxicillin-clavulanate arm, compared with 61% of PSSP carriers who received placebo; impacts of amoxicillin-clavulanate persisted at least 60 days after treatment among children who carried PSSP at enrollment. Amoxicillin-clavulanate therapy reduced PSSP acquisition by >80% over 15 days. Among children who carried PNSP at enrollment, no impacts on carriage prevalence of S. pneumoniae, PSSP, or PNSP were evident at follow-up visits.
Although the absolute risk of carrying PNSP was unaffected by treatment, antimicrobial therapy conferred a selective impact on colonizing pneumococci by accelerating clearance and delaying acquisition of PSSP.
The assessment of ear pain is challenging in young, mostly preverbal children. Our aim was to investigate whether pain scales are useful tools for parents to detect pain in their young children with ...the suspicion of acute otitis media (AOM), and to assess associations between 16 symptoms and the severity of pain.
This cross-sectional study included 426 children (6-35 months) with symptoms suggestive of AOM. We surveyed symptoms and pain via parental interview. As part of the interview, parents assessed their child's pain by using two pain scales: The Faces Pain Scale-Revised (FPS-R) and the Face, Legs, Activity, Cry, Consolability (FLACC) Scale. The outcome of interest was moderate/severe pain. We used the χ
test or Fisher's test as applicable to compare the severity of pain between three parental pain assessment methods (the parental interview, the FPS-R and the FLACC Scale). We also used multivariable logistic regression models to study the association between the severity of pain and AOM and to study the association between symptoms and the severity of pain.
In children with AOM (n = 201), pain was assessed by parents as moderate/severe in 65% via interview; 90% with the FPS-R; and 91% with the FLACC Scale (P < 0.001). In children without AOM (n = 225), the percentages were 56, 83 and 88%, respectively (P < 0.001). Between children with and without AOM, the occurrence of moderate/severe pain did not differ with any of the pain evaluation methods. Of symptoms, ear pain reported by child and restless sleep were significantly associated with moderate/severe pain, regardless of the pain evaluation method.
It seems that nearly all the children with respiratory tract infection, either with or without AOM, might suffer from moderate/severe pain. Without pain scales, parents may underestimate their child's pain. Of symptoms, ear pain reported by child and restless sleep might indicate pain in children with respiratory tract infection. We suggest that the adaptation of pain scales for parent observation is a possibility in children with respiratory tract infection which, however, requires further studies.
www.clinicaltrials.gov , identifier NCT00299455 . Date of registration: March 3, 2006.
The spectrum of acute symptoms in young outpatient children with respiratory tract infection (RTI) is variable, and it cannot be explained by the diagnosis of acute otitis media (AOM) versus ...uncomplicated RTI. We studied that the variation of symptoms is explained by the nasopharyngeal bacteria and/or respiratory viruses.
Children aged 6-35 months with acute symptoms with AOM (n = 201) or without AOM (n = 225) were eligible in this cross-sectional study. We analyzed their nasopharyngeal samples for pathogenic bacteria by culture and for respiratory viruses by polymerase chain reaction. We surveyed 17 symptoms (fever, respiratory, ear related, nonspecific, gastrointestinal) with a structured questionnaire.
Fever had a positive association with influenza viruses odds ratio (OR): 6.61; 95% confidence interval (CI): 1.66-26.27, human metapneumovirus (OR: 3.84; 95% CI: 1.25-11.77), coronaviruses (OR: 3.45; 95% CI: 1.53-7.75) and parainfluenza viruses (OR: 2.18; 95% CI: 1.07-4.47). Rhinitis (OR: 5.07; 95% CI: 1.93-13.36), nasal congestion (OR: 2.03; 95% CI: 1.25-3.31) and cough (OR: 1.91; 95% CI: 1.15-3.17) had positive associations with Moraxella catarrhalis. Furthermore, cough had a positive association with respiratory syncytial virus (OR: 7.20; 95% CI: 1.59-32.71) and parainfluenza viruses (OR: 2.79; 95% CI: 1.02-7.69).
The variation of acute symptoms in young children may be influenced by both nasopharyngeal bacteria and respiratory viruses. Our results showed a strong association between fever and respiratory viruses; rhinitis, nasal congestion and cough were associated with M. catarrhalis in the presence of viruses. Further studies are required to determine the possible synergistic role of M. catarrhalis in symptoms of RTI.
Acute symptoms are used to diagnose and manage acute otitis media (AOM). We studied whether AOM could be predicted by the reason for parental suspicion of AOM or by the occurrence, duration, and/or ...severity of symptoms. We also compared scores including or excluding tympanic-membrane examination of children with and without AOM.
Children aged 6 to 35 months with parental suspicion of AOM were eligible. Before tympanic-membrane examination, we registered on a structured questionnaire the reason for parental suspicion of AOM, symptoms, and score components.
Of 469 children studied, 237 had AOM and 232 had respiratory tract infection without AOM. The most common reason for parental suspicion of AOM, restless sleep, was not predictive for AOM (RR: 1.0 95% CI: 0.8-1.2), nor was ear-rubbing (relative risk RR: 0.7 95% confidence interval (CI): 0.5-1.0). Neither the occurrence of fever (RR: 1.2 95% CI: 1.0-1.4) nor the highest mean temperature within 24 hours predicted AOM, nor did the occurrences of ear-related, nonspecific, respiratory, or gastrointestinal symptoms. The duration and severity of symptoms were not predictive for AOM, although rhinitis lasted longer and conjunctivitis was more severe in children with AOM. The clinical/otologic score (median: 4.0 vs 2.0; P = .000) and the AOM total-severity index (11.0 vs 6.0; P = .000), both including symptoms and tympanic-membrane examination, were higher in those with AOM. The AOM severity-of-symptom scale, based solely on symptoms, was equal in children with and without AOM (6.0 vs 6.0; P = .917).
AOM cannot be predicted by the occurrence, duration, or severity of symptoms at otitis-prone age. Likewise, solely symptom-based scores do not differentiate between respiratory tract infections with or without AOM. Thus, tympanic-membrane examination is crucial in the diagnosis and severity classification of AOM in clinical practice and research settings.
Summary Objectives To understand relationships between microbes in pathogenesis of acute otitis media during respiratory tract infections, we compared nasopharyngeal bacteria and respiratory viruses ...in symptomatic children with and without AOM. Methods We enrolled children (6–35 months) with acute symptoms suggestive of AOM and analyzed their nasopharyngeal samples for bacteria by culture and for 15 respiratory viruses by PCR. Non-AOM group had no abnormal otoscopic signs or only middle ear effusion, while AOM group showed middle ear effusion and acute inflammatory signs in pneumatic otoscopy along with acute symptoms. Results Of 505 children, the non-AOM group included 187 and the AOM group 318. One or more bacterial AOM pathogen ( Streptococcus pneumoniae , Haemophilus influenzae , or Moraxella catarrhalis ) was detected in 78% and 96% of the non-AOM and AOM group, respectively ( P < .001). Colonization with S. pneumoniae and H. influenzae , each alone, increased risk of AOM (odds ratio (OR) 2.92; 95% confidence interval (CI), .91–9.38, and 5.13; 1.36–19.50, respectively) and co-colonization with M. catarrhalis further increased risk (OR 4.36; 1.46–12.97, and 9.00; 2.05–39.49, respectively). Respiratory viruses were detected in 90% and 87% of the non-AOM and AOM group, respectively. RSV was significantly associated with risk of AOM without colonization by bacterial AOM pathogens (OR 6.50; 1.21–34.85). Conclusions Co-colonization by M. catarrhalis seems to increase risk of AOM and RSV may contribute to AOM pathogenesis even without nasopharyngeal bacterial colonization.
Abstract Objective Spectral gradient acoustic reflectometry (SG-AR) may be used to detect middle ear effusion. Our aim was to investigate whether increasing SG-AR levels between two SG-AR ...examinations indicate deterioration from a healthy middle ear to acute otitis media (AOM). Methods We enrolled 185 children (age 6–35 months) whose parents were willing to use the SG-AR at home daily. Measurement pairs of parental home SG-AR examination results were generated and analyzed. There was one SG-AR examination result obtained within ±1 day of the reference visit and another result within ±1 day of the subsequent visit. We defined the SG-AR level as increasing when the difference between two measurements was ≥2 levels from a lower to a higher level, suggesting development of AOM. When the SG-AR level difference was ≤1, we defined this no change of the SG-AR level. The middle ear diagnosis was determined by pneumatic otoscopy at the study clinic. Results 361 paired SG-AR home measurements were obtained. The reference measurement was related to a healthy middle ear as determined by pneumatic otoscopy. Increasing SG-AR levels (59/361), were 63% (95% CI 50%–74%) sensitive and 94% (91%–97%) specific for deterioration of a healthy middle ear to AOM. The positive predictive value was 71% (58%–82%) and the negative predictive value was 92% (88%–95%). When there was no SG-AR level difference between the SG-AR examinations, the corresponding figures were 88% (95% CI 84%–92%), 69% (56%–79%), 93% (89%–95%) and 57% (45%–68%), respectively. Conclusions This study shows that increasing SG-AR levels might not be sufficiently sensitive to detect deterioration of the middle ear status from healthy middle ear to AOM in symptomatic children. Importantly, however, the development of AOM seems to be unlikely in an initially healthy middle ear when there is no difference between the SG-AR levels in two separate measurements.
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