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Grant Number: R01 HS10613
RFA/PA:
PI Name: MCCORMICK, DAVID
Project Title: OTITIS MEDIA: PARENT EDUCATION TO AVOID ANTIBIOTIC USE
Abstract:
MCCORMICK, DAVID P UNIVERSITY OF TEXAS MED BR GALVESTON, GALVESTON, TX OTITIS MEDIA: PARENT EDUCATION TO AVOID ANTIBIOTIC USE R01 HS10613-01 02/01/00 DESCRIPTION: Acute Otitis Media, AOM, remains a major child health problem around the world. The average child experiences 2.6 AOM episodes per year in the first two years of life. In addition, the widespread use of antibiotics in the treatment of AOM has resulted in the emergence of multi-drug resistant pathogens. Prior research indicates that as many as 80-90% of children with AOM will recover without antibiotics. However, there is a paucity of primary care research to guide the provider or parent as to which child might safely and compassionately be treated without antibiotics. This project is an investigator-blinded randomized clinical trial to establish the safety, efficacy, cost to parent and acceptability of an intervention consisting of education, non-antibiotic symptomatic therapy, and careful follow up in children with mild AOM. The diagnostic protocol combines otoscopic assessment of the tympanic membranes with five other key clinical measures to construct a standardized Total AOM Severity Score, differentiating mild from severe AOM. Parents of children with mild AOM will receive information about the risks and benefits of antibiotic treatment and subjects will be randomized to receive symptomatic care with or without antibiotic. Outcomes include parent satisfaction, nasopharyngeal carriage of multi-drug resistant S. pneumoniae organisms pre- and post-treatment, symptom scores, episodes of failure/relapse, unanticipated visits and phone calls due to AOM, untoward complications, days absent from school or day care (parent or child), and work (parent), parent costs, and cost-effectiveness. The goal is to establish the safety of withholding antibiotics from children with mild AOM and change the practice of universal antibiotic treatment for these patients. The research will result in publication of classification criteria, standardized photosets and parent education materials for use by clinicians. If the program is successful, the researchers will provide educational programs for clinicians and parents who are concerned about the excess use of antibiotics, the emergence of drug-resistant bacteria, and the high cost of AOM.
Fiscal Year: 2000
Department: UNIVERSITY OF TEXAS MEDICAL BR GALVESTON
Project Start: 03/01/2000
Project End: 07/31/2004
IRG: ZHS1
Related Publications:
Revai K, McCormick DP, Patel J, Grady JJ, Saeed K, Chonmaitree T (2006). "Effect of pneumococcal conjugate vaccine on nasopharyngeal bacterial colonization during acute otitis media." Pediatrics, Vol. 117, pp. 1823-1829
McCormick DP, Chonmaitree T, Pittman C, Saeed K, Friedman NR, Uchida T, Baldwin CD (2005). "Nonsevere acute otitis media: a clinical trial comparing outcomes of watchful waiting versus immediate antibiotic treatment." Pediatrics, Vol. 115, pp. 1455-1465
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