Efficacy of Antibiotics in Children with Acute Sinusitis: Which Subgroups Benefit?
抗生素对急性鼻窦炎儿童的疗效:哪些亚组受益?
基本信息
- 批准号:9069738
- 负责人:
- 金额:$ 97.54万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2015
- 资助国家:美国
- 起止时间:2015-06-01 至 2020-05-31
- 项目状态:已结题
- 来源:
- 关键词:12 year oldAcademyAccountingAcuteAmericanAmoxicillinAntibiotic ResistanceAntibiotic TherapyAntibioticsBacterial InfectionsChildClavulanateClinicalClinical Practice GuidelineColorControlled Clinical TrialsDataDecision MakingDiagnosisDiagnosticDoseDouble-Blind MethodElectronicsEnsureFeverGoalsGuidelinesHaemophilus influenzaeHealthIndividualLiteratureMoraxella (Branhamella) catarrhalisNasopharynxNational Institute of Allergy and Infectious DiseaseNatureNoseOutcomeOutcome MeasurePatientsPediatricsPlacebo ControlPlacebosPopulationPublic HealthRandomizedResearchRespiratory SystemRespiratory tract structureRiskSeveritiesSigns and SymptomsSinusitisStreptococcus pneumoniaeSubgroupSymptomsUpper Respiratory InfectionsViralWorkacute bacterial sinusitisantimicrobialbaseclinical decision-makingdiariesevidence baseevidence based guidelinesexperienceinnovationmeetingspathogenplacebo controlled studyrespiratoryresponse
项目摘要
DESCRIPTION (provided by applicant): Acute sinusitis is one of the most common diagnoses for which antimicrobials are prescribed for children in the US. Yet, available literature and our preliminary data suggest that only a subset of children diagnosed as having acute sinusitis based on current clinical criteria are likely to have bacterial disease. This finding, which is not
entirely surprising, reflects the large overlap between symptoms and signs of an uncomplicated viral upper respiratory tract infection (URI) and acute bacterial sinusitis. Accordingly, in a population of children diagnosed as having acute sinusitis, response to antimicrobials is likely to
be heterogeneous; those with true bacterial disease are likely to benefit substantially from antimicrobial therapy whereas those without bacterial disease would derive no benefit. The aim of this study is to identify subgroups of children who meet current diagnostic criteria for acute sinusitis, but in whom antimicrobial therapy provides no benefit. This objective will be achieved by conducting a large, randomized, double-blind, placebo-controlled clinical trial in children 2 to
12 years of age with persistent or worsening presentations of acute sinusitis. Children will be randomized to receive amoxicillin-clavulanate or placebo. Based on preliminary data we have gathered, we hypothesize that the subgroup of children who harbor no respiratory pathogens (Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis) in their nasopharynx, and the subgroup of children whose nasal discharge is grossly clear, are unlikely to have bacterial disease and therefore will not benefit from antimicrobial therapy. Innovations that will differentiate this study from previous studies include: 1) an experienced multidisciplinay research team working in a multicenter setting; 2) use of a well-validated measure of outcome; 3) use of electronic diaries to minimize the amount of missing data; and 4) a priori identification
of subgroups likely to respond differently to antimicrobial therapy. Should the proposed hypotheses be borne out, clinicians would be provided a basis for restricting antimicrobial use to specific subgroups of children who are most likely to benefit from it. Reduction of unnecessary antimicrobial use constitutes an important contribution to both individual and public health and is
in accord with our long-term goal and that of NIAID. Absent a study of this nature, it seems likely
that many children with uncomplicated viral URI will continue to be treated inappropriately with antimicrobials. This trial will offer a departure from an "all-or-none" approach to decision-making
regarding antimicrobials for acute sinusitis, and permit a more nuanced, evidence-based approach.
描述(由申请人提供):急性鼻窦炎是美国儿童最常见的诊断之一,为儿童开出了抗菌药。然而,现有的文献和我们的初步数据表明,根据目前的临床标准,只有部分被诊断为急性鼻窦炎的儿童可能患有细菌性疾病。这一发现,并不是
完全令人惊讶的是,这反映了简单的病毒性上呼吸道感染(URI)和急性细菌性鼻窦炎的症状和体征之间的巨大重叠。因此,在一群被诊断为患有急性鼻窦炎的儿童中,对抗菌素的反应可能会
是异质性的;那些真正患有细菌疾病的人可能会从抗菌治疗中获得实质性的好处,而那些没有细菌疾病的人则不会获得任何好处。这项研究的目的是确定符合当前急性鼻窦炎诊断标准的儿童亚组,但抗菌治疗对他们没有好处。这一目标将通过在2至10岁的儿童中进行大规模、随机、双盲、安慰剂对照的临床试验来实现。
12岁,有持续或恶化的急性鼻窦炎症状。儿童将被随机接受阿莫西林-克拉维酸盐或安慰剂治疗。根据我们收集的初步数据,我们假设鼻咽中没有呼吸道病原体(肺炎链球菌、流感嗜血杆菌或卡他莫拉菌)的儿童亚群,以及鼻腔分泌物大体透明的儿童亚群,不太可能患有细菌疾病,因此不会从抗菌治疗中受益。这项研究有别于以前研究的创新包括:1)在多中心环境下工作的经验丰富的多学科研究团队;2)使用经过充分验证的结果衡量标准;3)使用电子日记将丢失的数据量降至最低;以及4)先验识别
可能对抗菌药物治疗有不同反应的亚组。如果提议的假设得到证实,临床医生将被提供一个基础,将抗菌药物的使用限制在最有可能从中受益的特定儿童亚群中。减少不必要的抗菌剂使用是对个人和公共健康的重要贡献,而且是
符合我们的长期目标和NIAID的目标。如果没有这种性质的研究,似乎很可能
许多患有简单病毒性URI的儿童将继续接受不适当的抗菌药治疗。这次审判将提供一种“要么全有,要么全不”的决策方法
关于急性鼻窦炎的抗菌药,并允许采取更细微的、循证的方法。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Nader Shaikh其他文献
Nader Shaikh的其他文献
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{{ truncateString('Nader Shaikh', 18)}}的其他基金
Biomarkers for Urinary Tract Infection and Pyelonephritis
尿路感染和肾盂肾炎的生物标志物
- 批准号:
9884759 - 财政年份:2019
- 资助金额:
$ 97.54万 - 项目类别:
Modification of the Acute Otitis Media Severity of Symptoms Scale
急性中耳炎症状严重程度量表的修订
- 批准号:
9988638 - 财政年份:2019
- 资助金额:
$ 97.54万 - 项目类别:
Biomarkers for Urinary Tract Infection and Pyelonephritis
尿路感染和肾盂肾炎的生物标志物
- 批准号:
10619502 - 财政年份:2019
- 资助金额:
$ 97.54万 - 项目类别:
Efficacy of Antibiotics in Children with Acute Sinusitis: Which Subgroups Benefit?
抗生素对急性鼻窦炎儿童的疗效:哪些亚组受益?
- 批准号:
8926122 - 财政年份:2015
- 资助金额:
$ 97.54万 - 项目类别:
Efficacy of Antibiotics in Children with Acute Sinusitis: Which Subgroups Benefit?
抗生素对急性鼻窦炎儿童的疗效:哪些亚组受益?
- 批准号:
9279059 - 财政年份:2015
- 资助金额:
$ 97.54万 - 项目类别:
Corticosteroids for Children with Febrile Urinary Tract Infections
皮质类固醇治疗儿童发热性尿路感染
- 批准号:
8235802 - 财政年份:2011
- 资助金额:
$ 97.54万 - 项目类别:
Corticosteroids for Children with Febrile Urinary Tract Infections
皮质类固醇治疗儿童发热性尿路感染
- 批准号:
8443743 - 财政年份:2011
- 资助金额:
$ 97.54万 - 项目类别:
Corticosteroids for Children with Febrile Urinary Tract Infections
皮质类固醇治疗儿童发热性尿路感染
- 批准号:
8039734 - 财政年份:2011
- 资助金额:
$ 97.54万 - 项目类别:
Corticosteroids for Children with Febrile Urinary Tract Infections
皮质类固醇治疗儿童发热性尿路感染
- 批准号:
8636457 - 财政年份:2011
- 资助金额:
$ 97.54万 - 项目类别:
Corticosteroids for Children with Febrile Urinary Tract Infections
皮质类固醇治疗儿童发热性尿路感染
- 批准号:
8824520 - 财政年份:2011
- 资助金额:
$ 97.54万 - 项目类别:
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