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Publications and source records attributed to Pekka Karma.
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BACKGROUND: Clinical symptoms and signs in acute otitis media (AOM) may differ depending on the various pneumococcal serotypes causing the disease. Alteration in clinical presentation of AOM could be expected after wide-scale pneumococcal vaccinations if there were considerable differences between vaccine serotypes and nonvaccine serotypes. METHODS: In this study, data from 831 children in the control arm of the Finnish Otitis Media Vaccine Trial were used. The children were followed up prospectively in 8 study clinics from 2 to 24 months of age. If AOM was diagnosed, myringotomy was done, and middle ear fluid was aspirated for bacterial culture. Clinical symptoms and signs of AOM were routinely recorded on structured case report forms. RESULTS: Consistent with previous studies, 60% of pneumococcal episodes were caused by vaccine serotypes. There were no major differences between the clinical presentations of AOM due to different serotypes or serotype categories. However, earache was more often associated with AOM caused by vaccine and cross-reactive serotypes, compared with AOM caused by non-vaccine-related serotypes (42% vs. 29%; odds ratio, 1.66; 95% confidence interval, 1.02-2.70). CONCLUSIONS: Introduction of the currently available pneumococcal conjugate vaccine is unlikely to result in a remarkable alteration in the clinical presentation of pneumococcal AOM in infants.
BACKGROUND: The novel pneumococcal conjugate vaccine, PncCRM, has been shown to prevent acute otitis media caused by vaccine serotypes and to reduce otitis surgery. Our aim was to assess long term efficacy of the vaccine on tympanostomy tube placements. METHODS: Children with complete follow-up in the Finnish Otitis Media Vaccine Trial up to 24 months of age and still living in the study area (1490 of 1662 randomized at 2 months of age) were invited to a single visit at 4-5 years of age. The children had been vaccinated at 2, 4, 6 and 12 months of age with PncCRM or hepatitis B vaccine (control). Tympanostomy tube placements reported by parents at the visit were verified from hospital and private medical center records. Additionally, tympanostomy tube placements of all children were verified from the hospital discharge registry. Vaccine efficacy (VE) was estimated by comparing all events of tympanostomy tube placement between vaccine groups. RESULTS: During the vaccine trial (2-24 months of age), VE (95% confidence interval) in preventing tympanostomy tube placement was only 4% (-19-23%). Altogether 756 children were enrolled for the follow-up study. After 24 months of age, the rate of surgery was 3.5 per 100 person-years in the PncCRM and 5.7 per 100 person-years in the control children, giving VE of 39% (4-61%). In the hospital-based data of all children (N = 1490), VE of 44% was obtained (19-62%). CONCLUSIONS: Receipt of PncCRM vaccine at infancy was associated with a reduction in tympanostomy tube placement from 2 to 4-5 years of age.
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In acute otitis media (AOM), a means of prediction of the bacterial pathogen based on symptoms and signs would be valuable in selecting appropriate antimicrobial treatment. Children in the control arm (n=831) in the Finnish Otitis Media Vaccine Trial were prospectively observed in a study clinic setting from the age of 2 to 24 months. In patients with AOM, myringotomy with aspiration was performed, and middle ear fluid samples were cultured for bacterial pathogens. Symptoms and signs of respiratory infections were thoroughly recorded. Streptococcus pneumoniae, Moraxella catarrhalis, and Haemophilus influenzae were the most common bacterial pathogens. Pneumococcal AOM was associated with more-severe AOM characterized by fever and earache. AOM due to H. influenzae was associated with eye symptoms and findings. Accurate prediction of a bacterial cause of infection based on symptoms and signs of AOM was not possible, but a specific cause was predicted in some situations, with a high probability of applicability to clinical practice.
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