Short Course Versus Standard Course Antifungal Therapy for Pediatric Candidemia: A Multi-Center Randomized Controlled Trial
儿童念珠菌血症的短期疗程与标准疗程抗真菌治疗:一项多中心随机对照试验
基本信息
- 批准号:10487627
- 负责人:
- 金额:$ 146.86万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-08-05 至 2029-07-31
- 项目状态:未结题
- 来源:
- 关键词:AdultAmericasAnti-Bacterial AgentsAnti-Infective AgentsAntifungal AgentsAntifungal TherapyAutomobile DrivingBacteremiaBacterial InfectionsBenefits and RisksBiological AssayBiological MarkersBloodCandidaCandidiasisChildChildhoodClinicalCohort StudiesCommunicable DiseasesCommunitiesComparative StudyComplicationDataDiseaseDrug InteractionsEarly DiagnosisEffectivenessExpert OpinionFluconazoleFoundationsFundingFutureGuidelinesHuman ResourcesInfectionInternationalKnowledgeLaboratoriesLeadLength of StayMeasuresMethodologyMoldsMorbidity - disease rateMulticenter StudiesMycosesObservational StudyOtitis MediaOutcomeOutcome MeasurePatient-Focused OutcomesPatientsPharmaceutical PreparationsPneumoniaProspective StudiesPublishingRandomizedRandomized Clinical TrialsRandomized Controlled TrialsRecommendationResearchResearch PersonnelResolutionSiteSocietiesUnited States National Institutes of HealthUpdateUrinary tract infectionYeastsarmbasebiomarker performancecandidemiaclinical epidemiologycomparative effectiveness studydesigneffective therapyimprovedimproved outcomemolecular markermortalitymultidisciplinarynovelnovel markeroptimal treatmentsprospectiverandomized trialrapid diagnosisresponsestandard of caretherapy duration
项目摘要
Invasive candidiasis is the most common invasive fungal disease, and uncomplicated candidemia is the most
common presentation. Randomized controlled trials in adults and a prospective observational study in children
demonstrated primary treatment with an echinocandin antifungal improved outcomes. While these data inform
initial therapy choice, there remains a paucity of data regarding appropriate duration of therapy. Current
guidelines recommend 14 total days of antifungal therapy for candidemia regardless of clinical presentation and
initial response, yet this is based on opinion and not comparative data. Several studies have proven that shorter
durations of antibacterial therapy are safe and effective for the treatment of numerous serious bacterial
infections. However, there has been no comparative study to assess shorter versus standard duration therapy
for any invasive fungal disease. A large proportion of pediatric invasive candidiasis is uncomplicated candidemia
with relatively rapid clinical improvement on primary echinocandin therapy. It is hypothesized that these patients
do not require 14 days of therapy and instead would be effectively treated with a shorter duration. The primary
objective of this randomized controlled trial is to determine whether 7 more days of therapy is necessary after
completing an initial 7days of echinocandin therapy for pediatric candidemia. Subjects initially treated with an
echinocandin showing clinical improvement with blood culture clearance will be randomized at 7 days into one
of two arms: 1) cessation of therapy, or 2) continuation of therapy for 14 total days. This primary aim will include
a novel outcome measure, the desirability of outcome ranking (DOOR), which simultaneously captures benefits
and negative consequences of treatment. We will compare the DOOR outcome in children randomized to receive
7 days of an echinocandin only (short-course) versus 7 days of echinocandin therapy followed by 7 more days
of antifungal therapy (standard-course). We hypothesize that subjects randomized to short-course therapy will
on average have a higher DOOR measure than subjects randomized to standard-course therapy. The secondary
objective will assess utility of a novel biomarker, the T2Candida® assay, to provide supporting evidence for
effectiveness of short course therapy. We previously demonstrated the T2Candida® assay can rapidly diagnose
invasive candidiasis in children. However, there are no data on the utility of a negative biomarker to support
cessation of therapy. Aim 2 will compare the 14-day DOOR measure for subjects with a negative or positive
T2Candida® biomarker at day 7 of therapy within each study group. We hypothesize that a negative T2Candida®
biomarker at day 7 will be associated with a higher DOOR measure at day 14. This study will leverage the
Pediatric Fungal Network (PFN), a multidisciplinary group composed of 37 sites across the US and the only such
group dedicated to pediatric invasive fungal disease. This will be the first randomized controlled trial to define
the optimal duration of therapy for any invasive fungal disease, and the first to explore the utility of a fungal
biomarker to support a shorter course. Results could impact numerous national and international guidelines.
侵袭性念珠菌病是最常见的侵袭性真菌疾病,其中单纯念珠菌病最为常见
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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Brian T Fisher其他文献
Disparities in CMV infection rates by race and ethnicity among pediatric allogeneic hematopoietic cell transplant recipients at a single center.
单一中心儿童同种异体造血细胞移植受者中不同种族和民族的 CMV 感染率差异。
- DOI:
- 发表时间:
2024 - 期刊:
- 影响因子:3.2
- 作者:
Craig L K Boge;Molly Hayes McDonough;Alexander M Newman;Jesse Blumenstock;CW Elgarten;J. L. Freedman;Timothy S Olson;Yun Li;Brian T Fisher - 通讯作者:
Brian T Fisher
Racial and ethnic disparities in acuity of presentation among children with newly diagnosed acute leukemia
新诊断急性白血病儿童表现敏锐度的种族和民族差异
- DOI:
- 发表时间:
2023 - 期刊:
- 影响因子:3.2
- 作者:
Lena E. Winestone;K. Getz;Yimei Li;Evanette K. Burrows;Michael E. Scheurer;Vicky Tam;M. Gramatges;J. Wilkes;Tamara P. Miller;A. Seif;K. Rabin;Brian T Fisher;R. Aplenc - 通讯作者:
R. Aplenc
Brian T Fisher的其他文献
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{{ truncateString('Brian T Fisher', 18)}}的其他基金
Short Course Versus Standard Course Antifungal Therapy for Pediatric Candidemia: A Multi-Center Randomized Controlled Trial
儿童念珠菌血症的短期疗程与标准疗程抗真菌治疗:多中心随机对照试验
- 批准号:
10677753 - 财政年份:2022
- 资助金额:
$ 146.86万 - 项目类别:
Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
小儿肺部侵袭性霉菌感染的无创诊断
- 批准号:
10543223 - 财政年份:2018
- 资助金额:
$ 146.86万 - 项目类别:
Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
小儿肺部侵袭性霉菌感染的无创诊断
- 批准号:
10163791 - 财政年份:2018
- 资助金额:
$ 146.86万 - 项目类别:
Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
小儿肺部侵袭性霉菌感染的无创诊断
- 批准号:
10421301 - 财政年份:2018
- 资助金额:
$ 146.86万 - 项目类别:
Fungal biomarkers for diagnosis and response to therapy for pediatric candidemia
用于儿童念珠菌血症诊断和治疗反应的真菌生物标志物
- 批准号:
8760875 - 财政年份:2014
- 资助金额:
$ 146.86万 - 项目类别:
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