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临床试验/NCT02297815
NCT02297815已完成不适用

Comparative Effectiveness of Broad vs. Narrow Spectrum Antibiotics for Acute Respiratory Tract Infections in Children

Children's Hospital of Philadelphia1 个研究点 分布在 1 个国家目标入组 2,472 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
2,472
试验地点
1
主要终点
Health Related Quality of Life Score

研究概览

简要总结

The purpose of this study is to identify and use patient centered outcomes to compare narrow-spectrum and broad-spectrum antibiotics for the treatment of common acute respiratory tract infections (ARTIs) in children.

详细描述

Outpatient, ARTIs account for the vast majority of antibiotic exposure to children, and roughly half of these antibiotic prescriptions are inappropriate. Although unnecessary antibiotic prescribing for viral infections has significantly decreased, there has been a substantial increase in prescribing of broad-spectrum antibiotics to treat ARTIs when narrow-spectrum antibiotics are indicated. Primary care providers, patients, and caregivers would benefit from studies assessing the implications of alternate antibiotic regimens for these common infections. Specifically, it remains unclear if treating common ARTIs with broad-spectrum antibiotics leads to an improvement in patient outcomes compared to treatment with narrow-spectrum antibiotics, particularly considering the increasing threat posed by antimicrobial resistance. Because of the lack of large comparative effectiveness studies with patient-centered outcomes addressing this issue, professional guidelines and expert recommendations are conflicting, and, as a result, practice patterns vary considerably. Therefore, using patient-centered outcomes, we aim to compare narrow-spectrum and broad-spectrum antibiotics for the treatment of common ARTIs in children. To accomplish this, we will perform a prospective cohort study of children receiving antibiotics for ARTI across a comprehensive pediatric healthcare network. We will conduct telephone interviews with parent's of children who receive antibiotic treatment for an ARTI. We will assess previously identified patient-centered outcomes included a health-related quality of life measure, occurrence of side effects, missed school/daycare, parent missed commitments and/or required additional childcare and symptoms were still present on day 3 after diagnosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Months 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • We included children between six months and 12 years old, diagnosed with an ARTI (acute otitis media, acute sinusitis, Group A streptococcal [GAS] pharyngitis) using International Classification of Diseases diagnosis codes and prescribed an antibiotic. For GAS pharyngitis, the child also had a positive rapid streptococcal test.

排除标准

  • Diagnosed with multiple ARTIs
  • Diagnosed with another non-ARTI bacterial infection
  • Prescribe antibiotics in the past 30 days
  • Non-English speaking families
  • If GAS pharyngitis diagnosis, age < 3 years

研究组 & 干预措施

Narrow-spectrum

Children diagnosed with an acute respiratory tract infections (ARTI) and prescribed Narrow-spectrum antibiotics.

干预措施: Narrow-spectrum antibiotics (Drug)

Broad-spectrum antibiotics

Children diagnosed with an acute respiratory tract infections (ARTI) and prescribed Broad-spectrum antibiotics.

干预措施: Broad-spectrum antibiotics (Drug)

结局指标

主要结局

Health Related Quality of Life Score

时间窗: 5-10 days after ARTI diagnosis

The health related quality of life score was obtained using the PedsQL(TM) (Mapi Research Trust, Lyon, France. www.pedsql.org) Parent-Proxy Report Generic Core Scales and Parent Report Infant Scales administered during the 5-10 day interview. Briefly, the PedsQL(TM) is a 23-item questionnaire assessing developmentally appropriate metrics (questions vary by age group: 1-12 months, 13-24 months, 2-4 years, 5-7 years, 8-12 years) related to core dimensions of health and role functioning. Our primary outcome was the Total Scale Score, which is a summary score of physical, emotional, social, and school functioning. The score range is zero to 100 and higher scores indicate a better health-related quality of life.

次要结局

  • Missed School or Daycare From Illness(5-10 days after ARTI diagnosis)
  • Required Additional Childcare(5-10 days after ARTI diagnosis)
  • Experience Side Effects(14-20 days after ARTI diagnosis)
  • Symptoms Present on Day 3(3 days after ARTI diagnosis)
  • Sleep Disturbance(Days 5-10 Interview)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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