jRCT1031260275招募中不适用
A multicenter prospective cohort study to elucidate the clinical characteristics of non-HIV Pneumocystis pneumonia [RE-VISION-PCP 2 prospective study]
未提供0 个研究点目标入组 233 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 233
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients clinically diagnosed with non-HIV Pneumocystis pneumonia (non-HIV PCP) by a physician
- •Definition of PCP diagnosis
- •In principle, the diagnosis should meet all of the following criteria.
- •Host factor
- •HIV infection or a non-HIV condition associated with possible immunodeficiency.
- •Clinical criteria
- •Clinical symptoms consistent with PCP (dyspnea, cough, fever, or hypoxemia),
- •Chest radiograph or chest CT findings compatible with PCP (including bilateral or diffuse ground-glass opacities).
- •Microbiological criteria
- •Detection of Pneumocystis species in respiratory specimens (e.g., sputum or bronchoalveolar lavage fluid) by conventional staining methods (Grocott stain or Diff-Quick stain) or nucleic acid testing (LAMP or PCR),
- •An elevated serum beta-D-glucan level.
- •If the results of microbiological testing are not yet available because they require additional time, Criterion 3 does not necessarily need to be fulfilled. Cases are acceptable if the physician makes an overall clinical diagnosis of non-HIV PCP.
- •In principle, serum beta-D-glucan levels should be measured using either the Beta-Glucan Single M30 Test Wako (FUJIFILM Wako Pure Chemical Corporation) or the FUNGITEC G Test MKII (Nissui Pharmaceutical Co., Ltd.). An elevated serum beta-D-glucan level is defined as greater than 5 pg/mL when measured using the Beta-Glucan Single M30 Test Wako or greater than 20 pg/mL when measured using the FUNGITEC G Test MKII. However, if a new beta-D-glucan assay becomes available or measurement is performed using another validated method, this definition does not apply.
- •2.Patients who are 18 years of age or older at the time informed consent is obtained.
- •3.Patients who have provided written informed consent to participate in this study.
排除标准
- •Patients who, in the judgment of the principal investigator (or sub-investigator), are unable or unwilling to cooperate with data collection or follow-up for this study.
- •Patients who, in the judgment of the principal investigator (or sub-investigator), are considered inappropriate for participation in this study for any other reason.
研究者
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