Antimicrobial Tracheostomy Tube to Prevent Biofilm and Reduce InfectionRisks
抗菌气管切开插管可防止生物膜并降低感染风险
基本信息
- 批准号:9904325
- 负责人:
- 金额:$ 59.06万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2017
- 资助国家:美国
- 起止时间:2017-01-06 至 2022-03-31
- 项目状态:已结题
- 来源:
- 关键词:Acinetobacter baumanniiAddressAnimal ModelAnimalsAntibiotic ResistanceAntibiotic TherapyAntibioticsAntimicrobial Cationic PeptidesBacteriaBacterial PneumoniaCellulitisChildChildhoodChronic DiseaseClinicalDataDevelopmentDevicesDrainage procedureEngineeringEnteral FeedingFamilyFamily suidaeFormulationFoundationsGoalsImmune systemInfectionLicensingMechanical ventilationMechanicsMicrobial BiofilmsModelingMorbidity - disease rateNosocomial InfectionsOperative Surgical ProceduresPatientsPeptidesPerformancePhasePolymersPrimary InfectionProceduresProcessPseudomonas aeruginosaQuality of lifeResistanceRespiratory TherapyRespiratory Tract InfectionsRiskSafetySterilizationStomasStreptococcus pneumoniaeTestingTracheitisTracheostomy TubeTracheostomy procedureTracheotomy procedureTreatment CostTubeTympanostomyVoice ProsthesesWorkantimicrobialantimicrobial peptideasparaginasebacterial resistancebasebiomaterial compatibilitycostcytotoxicitydrug resistant bacteriaefficacy studyendotrachealhospital readmissionhydrophilicityimprovedin vitro activityin vivoinnovationmeetingsmethicillin resistant Staphylococcus aureusmortalitymulti-drug resistant pathogennovelpathogenpediatric patientspre-clinicalpreclinical efficacypreclinical safetyprematurepreservationpreventrecurrent infectionsafety studysuccessventilator-associated pneumonia
项目摘要
ABSTRACT
The goal of this application is to develop an antimicrobial tracheostomy tube (TT) to reduce infections
associated with tracheostomies and prolonged mechanical ventilation (PMV). Approximately 100,000 patients
undergo a tracheotomy each year in the US.1 About 5000 of these patients are children, making it one of the
most common pediatric surgical airway procedures.2 The number of tracheostomies in children has increased
substantially in recent years and is expected to continue to rise, largely due to an increase in survival of
children born prematurely and with chronic disorders. Tracheostomy related infections are common and
include stoma cellulitis, tracheitis, and bacterial pneumonia, including ventilator associated pneumonia (VAP).
In children that receive a tracheostomy and are discharged with a TT in place, 17% have an unplanned
hospital readmission within 30 days and over 40% are readmitted within one year for bacterial tracheostomy
associated respiratory tract infection (bTARTI).3, 4 Biofilms form rapidly on TTs and harbor bacteria that are
resistant to antibiotics and the patient’s immune system. These biofilms contribute to infections and the
persistence of infections under treatment, especially in patients dependent on PMV. Although problems
associated with biofilm formation on TTs have been clearly identified, today there are no antimicrobial TTs
available. We hypothesize that preventing biofilm formation on TTs will improve their safety and function and
believe that there is a substantial commercial opportunity to address this unmet need.
The Phase II scope of work builds on strong Phase I results that established the ability to coat PVC based
tracheal tubes with a novel formulation of an engineered antimicrobial peptide. Coated devices were effective
at preventing biofilm formation by multidrug resistant pathogens and were biocompatible in cytotoxicity studies.
The coated ETTs were also shown to be mechanically durable and remained stable/active post sterilization.
Phase II objectives include (1) optimizing the coating formulation, (2) developing pilot scale coating process
requirements, (3) evaluating safety and efficacy in a large animal model, (4) completing biocompatibility and
bench testing, and (5) completing a pre-submission meeting with FDA.
Success of this project is expected to have a significant impact on the safety and quality of life of
tracheostomized patients and their families by preventing ventilator associated pneumonia and unplanned
hospital readmissions due to respiratory tract infections. This has high potential to reduce treatment cost. It
may also reduce the number of patients requiring antibiotic therapy and, in this way, help preserve the efficacy
of front line clinical antibiotics.
抽象的
应用的目的是开发抗菌气管造口术管(TT)以减少感染
与气管托管和延长的机械通气有关(PMV)
每次进行气管切开术-1美国。1大约5000个过去是儿童,使其成为其中之一
最常见的小儿外科气道程序。2儿童的气管阶层数量有所增加
在最近一年中,大部分时间已被曝光以遏制增加,由于生存率的增加而更大
过早出生的儿童和慢性疾病。
包括骨膜炎,气管炎和细菌性肺炎,包括呼吸机相关肺炎(VAP)。
在接受气管造口术并与原处出院的儿童中,有17%的人有一个未分布的
细菌气管造口的一年之内30天内的医院再入院和40%以上的重新入院
相关的呼吸道感染(Btarti).3,4个生物膜在TTS和港口细菌上迅速形成
对抗生素和患者的免疫系统的抗性。
在治疗下的感染持续性,特别是在患者中依赖PMV
与TTS上的生物膜形成相关,已经清楚地鉴定出来,今天有抗菌TTS
可用。
相信这是添加这种未满足需求的实质性商业选择。
第二阶段的工作范围建立在强大的I期结果上,该结果确立了基于PVC的能力
带有工程和微生物肽的新型的气管试管有效。
通过多药耐药病原体预防生物膜形成,在细胞毒性研究中是生物相容性的。
涂层的ETT还显示出机械耐用,并在转导后稳定/主动。
II阶段目标包括(1)优化涂料公式,(2)开发飞行员量表合作过程
要求,(3)评估大型动物模型中的安全性和功效,(4)兼容性和
台式测试和(5)组成与FDA进行预审会议。
期望该项目的成功对
气管静态患者及其家人通过预防呼吸机相关的肺炎和未分布
由于呼吸道感染而导致的医院
还可能减少需要抗生素治疗的患者数量,并在本周帮助保留疗效
前线临床抗生素。
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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Jennifer Ann Neff其他文献
Jennifer Ann Neff的其他文献
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{{ truncateString('Jennifer Ann Neff', 18)}}的其他基金
Antimicrobial Peptide Treatment to Combat Wound Biofilm
对抗伤口生物膜的抗菌肽治疗
- 批准号:
10223891 - 财政年份:2018
- 资助金额:
$ 59.06万 - 项目类别:
Antimicrobial Peptide Treatment to Combat Wound Biofilm
对抗伤口生物膜的抗菌肽治疗
- 批准号:
10082365 - 财政年份:2018
- 资助金额:
$ 59.06万 - 项目类别:
Dual Function Catheter to Prevent Thrombus and Infection
预防血栓和感染的双功能导管
- 批准号:
8058437 - 财政年份:2005
- 资助金额:
$ 59.06万 - 项目类别:
Dual Function Catheter to Prevent Thrombus and Infection
预防血栓和感染的双功能导管
- 批准号:
8249463 - 财政年份:2005
- 资助金额:
$ 59.06万 - 项目类别:
Dual Function Catheter to Prevent Thrombus and Infection
预防血栓和感染的双功能导管
- 批准号:
8459534 - 财政年份:2005
- 资助金额:
$ 59.06万 - 项目类别:
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