RESUMEN
BACKGROUND: Recommendations vary regarding immediate antimicrobial treatment versus watchful waiting for children younger than 2 years of age with acute otitis media. METHODS: We randomly assigned 291 children 6 to 23 months of age, with acute otitis media diagnosed with the use of stringent criteria, to receive amoxicillin-clavulanate or placebo for 10 days. We measured symptomatic response and rates of clinical failure. RESULTS: Among the children who received amoxicillin-clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7; among children who received placebo, 28% had initial resolution of symptoms by day 2, 54% by day 4, and 74% by day 7 (P=0.14 for the overall comparison). For sustained resolution of symptoms, the corresponding values were 20%, 41%, and 67% with amoxicillin-clavulanate, as compared with 14%, 36%, and 53% with placebo (P=0.04 for the overall comparison). Mean symptom scores over the first 7 days were lower for the children treated with amoxicillin-clavulanate than for those who received placebo (P=0.02). The rate of clinical failure--defined as the persistence of signs of acute infection on otoscopic examination--was also lower among the children treated with amoxicillin-clavulanate than among those who received placebo: 4% versus 23% at or before the visit on day 4 or 5 (P<0.001) and 16% versus 51% at or before the visit on day 10 to 12 (P<0.001). Mastoiditis developed in one child who received placebo. Diarrhea and diaper-area dermatitis were more common among children who received amoxicillin-clavulanate. There were no significant changes in either group in the rates of nasopharyngeal colonization with nonsusceptible Streptococcus pneumoniae. CONCLUSIONS: Among children 6 to 23 months of age with acute otitis media, treatment with amoxicillin-clavulanate for 10 days tended to reduce the time to resolution of symptoms and reduced the overall symptom burden and the rate of persistent signs of acute infection on otoscopic examination. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00377260.).
Asunto(s)
Combinación Amoxicilina-Clavulanato de Potasio/uso terapéutico , Antibacterianos/uso terapéutico , Otitis Media/tratamiento farmacológico , Enfermedad Aguda , Combinación Amoxicilina-Clavulanato de Potasio/efectos adversos , Antibacterianos/efectos adversos , Diarrea/inducido químicamente , Femenino , Humanos , Lactante , Masculino , Nasofaringe/microbiología , Otitis Media/diagnóstico , Otoscopía , Pronóstico , Recurrencia , Análisis de Regresión , Streptococcus pneumoniae/aislamiento & purificación , Insuficiencia del TratamientoRESUMEN
METHODS: Before and after introduction of pneumococcal conjugate vaccine (PCV7), the authors obtained nasopharyngeal (NP) specimens from 3 groups of children aged 6 to 23 months with acute otitis media (AOM): group 1 (pre-PCV7), group 2 (early post-PCV7), and group 3 (late post-PCV7). RESULTS: Of the Streptococcus pneumoniae isolates, the proportion that were vaccine serotypes (VTs) declined progressively (60.4% vs 48.6% vs 5.2% in groups 1, 2, and 3, respectively; P < .001). Concurrently, increases occurred in the proportion of penicillin-nonsusceptible isolates (minimum inhibitory concentration >0.1 µg/mL; 26.7% vs 37.8% vs. 38.5%; P = .12); the proportion of isolates that were serotype 19A (4.0% vs 0% vs 25.9%; P < .001); and the proportion of 19A isolates that were penicillin-nonsusceptible (0% in group 1, 68.6% in group 3; P = .004). CONCLUSION: Shifts in pneumococcal serotype distribution and increases in penicillin nonsusceptibility among pneumococcal isolates from children with AOM underscore the need for continuing bacteriological surveillance for future vaccine development.
Asunto(s)
Farmacorresistencia Bacteriana , Otitis Media/microbiología , Infecciones Neumocócicas/prevención & control , Vacunas Neumococicas/inmunología , Streptococcus pneumoniae/clasificación , Streptococcus pneumoniae/aislamiento & purificación , Enfermedad Aguda , Femenino , Humanos , Lactante , Masculino , Nasofaringe/microbiología , Otitis Media/inmunología , Infecciones Neumocócicas/microbiología , Vacunas Neumococicas/administración & dosificación , Serotipificación , VacunaciónRESUMEN
BACKGROUND: Acute otitis media (AOM) is the most common childhood diagnosis, leading to prescription of an antibiotic in the United States. Although antibiotics are used in children with AOM, in part, to shorten the duration of symptoms, no instruments have been developed to track early changes in symptoms from the parent's point of view. The goal of the present study was to develop and evaluate a parent-reported symptom scale for children with AOM (AOM-SOS) for use as an outcome measure in AOM treatment trials. METHODS: From a pool of 28 potential symptoms, we selected 7 on the basis of parent questionnaire, expert interviews, and review of the literature for inclusion in the AOM-SOS. We administered the AOM-SOS to a primary-care sample of children aged 6-25 months enrolled in a study of nasopharyngeal bacterial colonization. Children were seen for well visits, illness visits, and AOM follow-up visits. At each visit, parents completed the AOM-SOS and their children were examined by trained otoscopists. As part of the evaluation of the AOM-SOS, we examined the association between each item on the questionnaire and the clinical diagnosis of AOM while adjusting for the presence of upper respiratory tract infection. To assess responsiveness, we examined the change in AOM-SOS scores in patients with AOM who were seen for follow-up within 3 weeks of diagnosis. RESULTS: We evaluated 264 children (mean age, 12.5 months at entry) at a total of 642 visits. We diagnosed AOM at 24% of the visits. Each item on the questionnaire was significantly associated with the clinical diagnosis of AOM (P < 0.001 for each), before and after adjusting for the presence or absence of upper respiratory infection. The mean AOM-SOS score at visits when AOM was diagnosed was 3.71, compared with 0.96 at visits when AOM was not diagnosed (P < 0.001). Internal reliability of the scale as measured by Cronbach's alpha was 0.84. AOM-SOS scores in children with AOM who were otoscopically improved decreased by an average of 2.81 points (standardized response mean = 0.73). CONCLUSIONS: We have developed a short symptom scale for children with AOM. This study provides preliminary data on the performance of the AOM-SOS in a primary care sample of children.
Asunto(s)
Ensayos Clínicos como Asunto/métodos , Otitis Media/diagnóstico , Enfermedad Aguda , Adulto , Preescolar , Femenino , Humanos , Lactante , Masculino , Otitis Media/tratamiento farmacológico , Otitis Media/patología , Reproducibilidad de los Resultados , Autorrevelación , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
BACKGROUND: Because resolution of symptoms is a primary goal of antimicrobial therapy in children with acute otitis media (AOM), measurement of symptoms in studies of antimicrobial effectiveness in such children is important. We have developed a scale for measuring symptoms of AOM in young children (AOM-SOS), and we present data on its construct validity and responsiveness. METHODS: We followed children 3 months to 3 years of age with AOM, who were receiving antimicrobial treatment, using the AOM-SOS scale. The scale was administered at the enrollment visit, as a twice-a-day diary measure, and at the follow-up visit (days 5-7). To evaluate construct validity, we examined the correlation, at entry, between AOM-SOS scores and scores on other measures of pain and functional status. To evaluate the scale's responsiveness, we examined the change in scale scores from entry to follow-up. We also examined the levels of agreement between the scale scores and overall assessments of the children by parents. RESULTS: We enrolled 70 children (mean age 12.5 months) of whom 57 returned for follow-up. The magnitude of the correlations between the AOM-SOS scale scores and other measures of pain and functional status ranged from 0.56 to 0.84. The responsiveness of the AOM-SOS, as measured by the standardized response mean was 1.20. CONCLUSIONS: These data support the validity and responsiveness of the AOM-SOS; the scale seems to measure effectively both pain and overall functional status in young children with AOM. Changes in score over the first few days of illness were substantial and generally matched the assessments both of parents and of clinicians. The AOM-SOS promises to be useful as an outcome measure in clinical studies of AOM.
Asunto(s)
Otitis Media/diagnóstico , Índice de Severidad de la Enfermedad , Enfermedad Aguda , Manejo de Caso , Distribución de Chi-Cuadrado , Preescolar , Estudios Transversales , Femenino , Humanos , Lactante , Masculino , Otitis Media/tratamiento farmacológico , Otitis Media/patología , Dimensión del Dolor/métodos , Padres , Reproducibilidad de los Resultados , Encuestas y CuestionariosRESUMEN
CONTEXT: Acute otitis media (AOM) frequently complicates influenza infection. Previous studies have found influenza vaccine effective in reducing the occurrence of AOM in children mainly older than 2 years. OBJECTIVE: To evaluate the effectiveness of inactivated influenza vaccine in preventing AOM in children aged 6 to 24 months. DESIGN, SETTING, AND PATIENTS: Randomized, double-blind, placebo-controlled trial of 786 children aged 6 to 24 months enrolled at Children's Hospital of Pittsburgh before the 1999-2000 (411 children) and 2000-2001 (375 children) respiratory seasons (defined as December 1 through March 31 of the respective following year). Children received influenza vaccine or placebo in a 2:1 ratio. The first cohort was observed for 1 year and the second cohort until the end of the ensuing respiratory season. INTERVENTION: Two doses (0.25 mL each) of inactivated trivalent subvirion influenza vaccine or placebo were administered intramuscularly approximately 4 weeks apart. MAIN OUTCOME MEASURES: Proportion of children who developed AOM, monthly occurrence rate of AOM, estimated proportion of time with middle ear effusion, and utilization of selected health care and related resources. RESULTS: Of the 66 children in the vaccine group from whom serum samples were collected, seroconversion against strains in the vaccine formulations developed in 88.6% to 96.8%, depending on the specific strain. The efficacy of the vaccine against culture-confirmed influenza was 66% (95% confidence interval [CI], 34%-82%) in 1999-2000 and -7% (95% CI, -247% to 67%) in 2000-2001; however, influenza attack rates differed between these 2 periods (in the placebo group, 15.9% and 3.3%, respectively). Compared with placebo, influenza vaccine did not reduce the proportion of children who had at least 1 episode of AOM during the respiratory season (in the first cohort: vaccine, 49.2% vs placebo, 52.2%; P =.56 ]; in the second cohort: vaccine, 55.8% vs placebo, 48.3%; P =.17). The vaccine also did not reduce the monthly rate of AOM; the estimated proportion of time with middle ear effusion; or the utilization of selected health care and related resources. There were also no differences between the vaccine and placebo groups regarding any of these outcomes during peak influenza periods. The vaccines administered to both cohorts of children were well tolerated. CONCLUSION: Administration of inactivated trivalent influenza vaccine to children aged 6 to 24 months did not reduce their burden of AOM or their utilization of selected health care and related resources.