Determination of the Utility of Pfizer's Pneumococcal Urine Antigen Test in Children 5 Years of Age or Younger With Community Acquired Pneumonia in Guatemala

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追踪信息

首次提交日期 ^ICMJE

October 1, 2018

首次发布日期e ^ICMJE

October 4, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

November 2018

预计主要完成日期

October 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Urinary antigen detection cut-points for invasive S. pneumoniae disease[ Time Frame: Within 48 hours ]

To determine Cut-Points to discriminate a positive or negative urine antigen test that differentiates invasive disease versus the carriage state

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Detection of S. pneumoniae serotypes using Urinary antigen detection assay[ Time Frame: Within 48 hours ]
To determine the sensitivity and specificity of the Luminex xMPA pneumococcal UAD in the identification of S. pneumoniae serotypes (PCV13 serotypes) in children with radiologically confirmed CAP

描述性信息

简略标题 ^ICMJE

Determination of the Utility of Pfizer's Pneumococcal Urine Antigen Test in Children 5 Years of Age or Younger With Community Acquired Pneumonia in Guatemala

正式标题 ^ICMJE

Determination of the Utility of Pfizer's Pneumococcal Urine Antigen Test in Children 5 Years of Age or Younger With Community Acquired Pneumonia in Guatemala

简要概况

This prospective case-control study aims to evaluate the utility and establish laboratory thresholds for a multi-serotype urine antigen test for the diagnosis of pneumococcal community acquired pneumonia in children 5 years of age or younger in Guatemala.

详细说明

研究类型 ^ICMJE

Observational

研究阶段

研究设计 ^ICMJE

分配:
干预模型:
干预模型描述:
盲法: Observational
盲法描述:
主要目的:

适用条件 ^ICMJE

干预项目 ^ICMJE

Other: Urinary antigen detection assay
Screening for Ag level in S. pneumoniae urinary antigen detection assay.

研究工具

: Cases
Suspected community-acquired bacterial pneumonia
: Controls
Healthy children, age-matched to enrolled cases

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

960

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

October 2020

预计主要完成日期

October 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

CASES: Inclusion Criteria: - Age older than 1 month (31 days) and up to 71 months and 28 days. - Diagnosis of radiologically confirmed pneumonia per WHO criteria in the ED or hospital within 48 hours of hospital admission - Signed informed consent by parents or legal guardian to participate in the study Exclusion Criteria: - Known immunodeficiency - Major congenital malformation (e.g., hemodynamically compromised congenital heart malformation or any malformation leading to recurrent pneumonia) or serious chronic disorder - Significant neurological disorder - Hospitalization within the previous 30 days for pneumonia or respiratory infection - Use of parenteral antibiotics for current illness (leading to diagnosis of pneumonia) - Transferred to the study hospital after already being hospitalized at a different location for ≥ 48 hours CONTROLS: Inclusion Criteria: - Age 1 to 71 months and signed informed consent by parents or legal guardian Exclusion Criteria: - Known immunodeficiency - Major congenital malformation (e.g., hemodynamically compromised congenital heart malformation or any malformation leading to recurrent pneumonia) or serious chronic disorder - Significant neurological disorder - Fever or suspicion of community-acquired pneumonia or other respiratory infectious disease (symptoms of cough, congestion, tachypnea, indrawing, etc.) - Hospitalization within the previous 30 days for pneumonia or respiratory infection

性别

参与研究的性别:

All

年龄

最小年龄：31 Days ，最大年龄：5 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

University of Colorado, Denver

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Edwin Asturias, MD University of Colorado - Anschutz Medical Campus

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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