Nonsevere Acute Otitis Media: A Clinical Trial Comparing Outcomes of Watchful Waiting Versus Immediate Antibiotic Treatment

• Published in: Pediatrics (Evanston) 2005-06, Vol.115 (6), p.1455-1465
• Main Authors: McCormick, David P, Chonmaitree, Tasnee, Pittman, Carmen, Saeed, Kokab, Friedman, Norman R, Uchida, Tatsuo, Baldwin, Constance D
• Format: Article
• Language: English
• Subjects: Amoxicillin - administration & dosage; Amoxicillin - therapeutic use; Analgesics - therapeutic use; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - therapeutic use; Antibiotics; Biological and medical sciences; Case Management; Child; Child, Preschool; Children; Clinical outcomes; Clinical trials; Diagnosis; Drug Resistance, Multiple, Bacterial; Drug therapy; Ears & hearing; Female; General aspects; Health aspects; Humans; Infant; Inflammatory diseases; Male; Medical sciences; Medical treatment; Nasopharynx - microbiology; Otitis media; Otitis Media - drug therapy; Otitis Media - microbiology; Otitis Media - therapy; Parents - psychology; Pediatrics; Personal Satisfaction; Recurrence; Severity of Illness Index; Single-Blind Method; Streptococcal Infections - drug therapy; Streptococcal Infections - microbiology; Streptococcal Infections - therapy; Streptococcus pneumoniae; Streptococcus pneumoniae - drug effects; Streptococcus pneumoniae - isolation & purification; Surveys and Questionnaires; Texas; Tympanic membrane
• ISSN: 0031-4005; 1098-4275
• DOI: 10.1542/peds.2004-1665

The widespread use of antibiotics for treatment of acute otitis media (AOM) has resulted in the emergence of multidrug-resistant pathogens that are difficult to treat. However, it has been shown that most children with nonsevere AOM recover without ABX. The objective of this study was to evaluate the safety, efficacy, acceptability, and costs of a non-ABX intervention for children with nonsevere AOM. Children 6 months to 12 years old with AOM were screened by using a novel AOM-severity screening index. Parents of children with nonsevere AOM received an educational intervention, and their children were randomized to receive either immediate antibiotics (ABX; amoxicillin plus symptom medication) or watchful waiting (WW; symptom medication only). The investigators, but not the parents, were blinded to enrollment status. Primary outcomes included parent satisfaction with AOM care, resolution of symptoms, AOM failure/recurrence, and nasopharyngeal carriage of Streptococcus pneumoniae strains resistant to ABX. Secondary outcomes included medication-related adverse events, serious adverse events, unanticipated AOM-related office and emergency department visits and telephone calls, the child's absence from day care or school resulting from AOM, the parent's absence from school or work because of their child's AOM, and costs of treatment. Subjects were defined as failing (days 0-12) or recurring (days 13-30) if they experienced a higher AOM-severity score on reexamination. A total of 223 subjects were recruited: 73% were nonwhite, 57% were