Safety and tolerability of clarithromycin administered to children at higher-than-recommended doses.

A tendency among pediatricians in Greece to use higher-than-recommended doses of clarithromycin was noted over several years, prompting this study of the safety and tolerability of this macrolide in 343 children over a period of 9 months. The study group comprised nonhospitalized patients of 29 pediatricians practicing in Athens. All were prescribed clarithromycin for upper respiratory (n = 257) or lower respiratory tract infection (n = 78). Overall, 77.8% were treated with doses that exceeded the recommended dose of 15 mg/kg/day, and 26% received doses of > or = 30 mg/kg/day (median dose, 20 mg/kg/day). The tolerability of clarithromycin was judged as "very good" in 75% of the children, as "good" in 16%, and as "moderate" in 5%, whereas intolerability was observed in 4% of the cases. Adverse reactions, mainly gastrointestinal in nature, were reported in 17.5% of the cases. With regard to both tolerability and adverse events recorded, there were no statistically significant differences between the group of patients who received the recommended dose and the group who received higher doses. Clarithromycin continues to present a safe and well-tolerated profile for the treatment of common pediatric infections, even when administered at higher-than-recommended doses. Whether it is more efficacious in this setting is a matter for further study.

Human rhinoviruses in otitis media with effusion.

Frequent viral upper respiratory tract infections (URTI) are considered to be risk factors for otitis media with effusion (OME). Atopy has also been associated with both OME and viral infections. The aim of this study was to evaluate the presence of viruses in middle ear effusions (MEE) in children 2-7 yr old with OME, and to determine risk factors for virus detection in the MEE. MEE samples, collected at the time of myringotomy from 37 children with OME were assessed. Physical examination, skin prick tests and a standardized questionnaire on OME and allergy were also performed. Viral RNA was detected by the use of reverse transcription PCR (RT-PCR). Fifteen samples (40.5%) were positive for rhinovirus (RV). One enterovirus and no other respiratory viruses were detected. Two out of five (40%), 3/7 (43%) and 10/25 (40%) were positive for RV in acute, subacute and chronic cases, respectively. Children with frequent episodes of OM, with early onset of OM (<2 yr old), and a positive family history of allergy had a statistically increased risk of RV detection. The two groups were comparable with respect to all other parameters examined. RV is the predominant virus recovered by RT-PCR in the middle ear cavity of children with asymptomatic OME, especially those with a history of longstanding OME or repeated episodes, or children with a family history of allergy. Interactions between allergy and RV infections are likely to predispose to middle ear disease.

IgE sensitization, respiratory allergy symptoms, and heritability independently increase the risk of otitis media with effusion.

BACKGROUND AND AIMS: Epidemiological evidence examining the role of atopy and/or allergy in the pathogenesis of otitis media with effusion (OME) is inconclusive. The aim of this study was to assess any increased risk for OME attributable to allergy-related factors, in a well-characterized population using a case-control design and multivariate analysis. SUBJECTS AND METHODS: Eighty-eight 1-7-year-old children with OME, diagnosed by clinical and tympanometric evaluation and 80 matched controls were enrolled. A standardized questionnaire was completed, in order to assess factors related to OME and allergy-related symptoms and diagnoses using strict clinical definitions. Specific IgE was measured by skin-prick tests and/or CAP-FEIA. RESULTS: The patient and control groups were well matched. Factors conferring increased risk for OME in the univariate analysis included IgE sensitization, dyspnea, wheezing, asthma, paroxysmal sneezing, rhinitis, eczema, 'any allergic disease,' family history of otitis media, and family history of allergy. After multivariate analysis IgE sensitization, wheezing, nasal obstruction, family history of otitis, and child-care attendance remained as independent risk factors for development of OME. CONCLUSION: IgE sensitization and respiratory allergy symptoms are independent risk factors for the development of OME, suggesting that both immunological and mechanical pathways may contribute to the development of the disease. Otitis heritability provides additional risk, as well as frequent exposure to viral upper respiratory tract infections in children attending daycare. Treatment and/or prevention of OME using anti-allergic medications should be further examined.