Comparative Tolerability, Safety and Efficacy of Tablet Formulations of Twice-Daily Clarithromycin 250 mg versus Once-Daily Extended-Release Clarithromycin 500 mg in Pediatric and Adolescent Patients
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Abstract
Clarithromycin is widely used to treat respiratory tract and superficial skin infections
in pediatric and adult populations. Using clinical endpoints and 7-day therapy, we
compared the efficacy of clarithromycin 250 mg tablets given twice daily versus clarithromycin
500 mg extendedrelease tablets given once daily in ambulatory children and adolescents
6 to 16 years old. Of the 199 evaluable patients, 124 were infected with group A streptococcal
pharyngitis, 39 with sinusitis, 21 with ambulatory pneumonia, and 15 with superficial
skin infections. The overall cure rate exceeded 90% for each treatment group. Discontinuation
rates and adverse events were 4.5% and 24.6%, respectively.
This evidence-based clinical practice guideline provides recommendations to primary care clinicians for the management of children from 2 months through 12 years of age with uncomplicated acute otitis media (AOM). The American Academy of Pediatrics and American Academy of Family Physicians convened a committee composed of primary care physicians and experts in the fields of otolaryngology, epidemiology, and infectious disease. The subcommittee partnered with the Agency for Healthcare Research and Quality and the Southern California Evidence-Based Practice Center to develop a comprehensive review of the evidence-based literature related to AOM. The resulting evidence report and other sources of data were used to formulate the practice guideline recommendations. The focus of this practice guideline is the appropriate diagnosis and initial treatment of a child presenting with AOM. The guideline provides a specific definition of AOM. It addresses pain management, initial observation versus antibacterial treatment, appropriate choices of antibacterials, and preventive measures. Decisions were made based on a systematic grading of the quality of evidence and strength of recommendations, as well as expert consensus when definitive data were not available. The practice guideline underwent comprehensive peer review before formal approval by the partnering organizations. This clinical practice guideline is not intended as a sole source of guidance in the management of children with AOM. Rather, it is intended to assist primary care clinicians by providing a framework for clinical decision-making. It is not intended to replace clinical judgment or establish a protocol for all children with this condition. These recommendations may not provide the only appropriate approach to the management of this problem.
In early 2000, a protein-polysaccharide conjugate vaccine targeting seven pneumococcal serotypes was licensed in the United States for use in young children. We examined population-based data from the Active Bacterial Core Surveillance of the Centers for Disease Control and Prevention to evaluate changes in the burden of invasive disease, defined by isolation of Streptococcus pneumoniae from a normally sterile site. Serotyping and susceptibility testing of isolates were performed. We assessed trends using data from seven geographic areas with continuous participation from 1998 through 2001 (population, 16 million). The rate of invasive disease dropped from an average of 24.3 cases per 100,000 persons in 1998 and 1999 to 17.3 per 100,000 in 2001. The largest decline was in children under two years of age. In this group, the rate of disease was 69 percent lower in 2001 than the base-line rate (59.0 cases per 100,000 vs. 188.0 per 100,000, P<0.001); the rate of disease caused by vaccine and vaccine-related serotypes declined by 78 percent (P<0.001) and 50 percent (P<0.001), respectively. Disease rates also fell for adults; as compared with base line, the rate of disease in 2001 was 32 percent lower for adults 20 to 39 years of age (7.6 cases per 100,000 vs. 11.2 per 100,000, P<0.001), 8 percent lower for those 40 to 64 years of age (19.7 per 100,000 vs. 21.5 per 100,000, P=0.03), and 18 percent lower for those 65 years of age or more (49.5 per 100,000 vs. 60.1 per 100,000, P<0.001). The rate of disease caused by strains that were not susceptible to penicillin was 35 percent lower in 2001 than in 1999 (4.1 cases per 100,000 vs. 6.3 per 100,000, P<0.001). The use of the pneumococcal conjugate vaccine is preventing disease in young children, for whom the vaccine is indicated, and may be reducing the rate of disease in adults. The vaccine provides an effective new tool for reducing disease caused by drug-resistant strains. Copyright 2003 Massachusetts Medical Society
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