A Longitudinal Observational Study Identifying Shifts in the Respiratory Microbiome and Clinical Outcomes of SARS-CoV-2 in Nursing Home Residents
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pathnostics
- 入组人数
- 185
- 试验地点
- 4
- 主要终点
- Percent of SARS-CoV-2 infection
研究概览
简要总结
This is a longitudinal, prospective observational study focusing on health-related outcomes relative to potential changes in the respiratory microbiome seen with weekly SARS-CoV-2 testing in nursing home residents.
详细描述
This study targets the influence of SARS-CoV-2, and the presence of mixed/co-infections on the respiratory microbiome. Their interrelationship will be characterized in a prospective observational study design. The observed changes will be correlated to medical (FEV1, CXR/CT, mortality, morbidity, symptoms) and clinical laboratory parameters (hematology, coagulation, bacterial/viral detection). The study aims at the detection of significant changes in microbiome in the respiratory tract following incidence of SARS-CoV-2 infection. These alterations in the respiratory microbiome will be determined by shotgun metagenomic sequencing. Ultimately, this can provide a better understanding of how SARS-CoV-2 and the presence of other bacteria and viruses affect the composition of the respiratory microbiome and a description of the microbiological etiology of these respiratory tract infections.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All residents of the nursing home facility, (M/F) 65 years or above, who have recently tested positive through Ohio's PARRT Program are eligible
- •Resident must submit weekly nasal swab sample per nursing home COVID testing guidelines
- •Clinical suspicion of a new episode of acute respiratory tract infection.
- •Laboratory confirmed SARS-CoV-2 infection by either a laboratory test, PCR or any other commercial or public health test
排除标准
- •Nursing home residents that are not taking part regularly in weekly screening for SARS-COV-2 or residents that test negative through Ohio's PARRT program cannot be included as part of study analyses
- •Residents on hospice, residents currently intubated, residents with scheduled transfer to another nursing home facility will not be included in study analyses
结局指标
主要结局
Percent of SARS-CoV-2 infection
时间窗: 4-8 weeks
Examine prospective data to determine the change from baseline (week 1 of testing) in resident/bed ratio positive for SARS-CoV-2.
Mortality rate due to SARS-CoV-2 infection with bacterial/viral co-infection
时间窗: 12 months
Examine prospective data to determine the mortality rate (outpatient and inpatient) due to SARS-CoV-2 with additional bacteria and/or virus identified at any time during SARS-Cov-2 PCR positivity prior to death.
Percent of all acute medical complications
时间窗: 4-8 weeks
Examine prospective data to determine the prevalence of all medical usual complications and geriatric acquired complications, such as delirium, falls, pressure sores, new infectious disease (UTI), cardiovascular, incidence of acute heart failure \[elevated BNP presence of new ECG abnormalities (ST elevation and/or T-wave inversion), myocardial injury \[reflected by elevation in cardiac troponin levels above the 99th percentile upper reference limit on admission, cerebrovascular disease \[Stroke, stroke subtype (ischemic, cryptogenic , metabolic disease manifestations DKA, hyperosmolar hyperglycemic state (HHS), and severe insulin resistance, Neurological Manifestations \[Anosmia/dysgeusia, Guillen Barre Syndrome, Meningoencephalitis, Encephalomyelitis, myoclonus (generalized), Rhabdomyolysis, VTE, DIC, PE, acute limb ischemia
Percent of asymptomatic SARS-Cov-2 positives and/or bacterial/viral infection
时间窗: 4-8 weeks
Examine prospective data to determine the percent of asymptomatic SARS-Cov-2 positives and/or bacterial/viral infection that never develop symptoms throughout infectious period and are alive/healthy at end of study.
Pulmonary function
时间窗: Baseline to any timepoint for 4 to 8 weeks
Examine prospective data to determine the the percent change in forced vital capacity (FVC), forced expiratory volume (FEV1), peak expiratory flow (PEF) in patients
Chest CT X-ray
时间窗: Baseline to any timepoint for 4 to 8 weeks
Examine prospective data to determine the percent of lung CT containing consolidation, percent of patients showing reticular patterns, percent containing pure ground-glass opacification, percent containing honeycomb appearance, percent containing Bronchiectasis
Percent of SARS-CoV-2 and viral co-infection
时间窗: 4-8 weeks
Examine prospective data to determine the change from baseline number of healthy \[SARS-CoV-2 naïve\] to number that develop respiratory tract infection. Percent of SARS-CoV-2 positives without an additional viral cause identified compared to percent of SARS-CoV-2 positives with viral co-infection identified.
Mortality rate due to SARS-CoV-2 infection
时间窗: 12 months
Examine prospective data to determine the mortality rate (outpatient and inpatient) due to SARS-CoV-2 only (no additional bacteria and/or virus identified on PCR at any time during SARS-CoV-2 PCR positivity prior to death.
Percent of pre-symptomatic SARS-Cov-2 positives and/or bacterial/viral infection
时间窗: 4-8 weeks
Examine prospective data to determine the percent of pre-symptomatic SARS-CoV-2 positives and/or bacterial/viral infection. This is the asymptomatic period PRIOR to a symptomatic period all during time of PCR positivity.
Percent of SARS-CoV-2 and bacterial co-infection
时间窗: 4-8 weeks
Examine prospective data to determine the change from baseline number of healthy \[SARS-CoV-2 naïve\] to number that develop respiratory tract infection. Percent of SARS-CoV-2 positives without a bacterial source of RTI compared to percent of SARS-CoV-2 positives with bacterial co-infection identified by either PCR, symptoms, CXR, CT, throat culture swab, RDT and documented in patient chart.
Symptoms of SARS-CoV-2 infection, bacterial co-infection, viral co-infection
时间窗: Up to 12 weeks post-PCR confirmation for a SARS-CoV-2 positive diagnosis
Any changes in symptom severity will be captured by monitoring the patient's chart for any updates in clinical progress notes. Any symptoms compatible with SARS-CoV-2 infection will be captured such as high temperature, dyspnea, diarrhea, vomiting, myalgia, pharynx pain, abdominal pain, anosmia, cough etc.
Percent of SARS-Cov-2 positives and/or bacterial/viral infection with full resolution by 30 days
时间窗: Up to 30 days after respiratory symptom onset
Examine prospective data to determine the percent of SARS-Cov-2 positives and/or bacterial/viral infection with full resolution by 30 days after respiratory symptom onset \[full resolution defined as resolution of acute onset clinical symptoms\].
Percent of SARS-Cov-2 positives and/or bacterial/viral infection that develop pneumonia-like symptoms
时间窗: 4-8 weeks
Examine prospective data to determine the percent of SARS-Cov-2 positives and/or bacterial/viral infection that develop pneumonia-like symptoms during SARS-CoV-2 PCR positivity
Changes in hematology
时间窗: Baseline to any timepoint for 4 to 8 weeks
Examine prospective data to identify changes in patient hematology through analysis of complete blood routines for CBC and WBC.
次要结局
- ALPHA Diversity (determined by NGS)(6-12 months)
- Taxon Identification (determined by NGS)(6-12 months)
- BETA Diversity (determined by NGS)(6-12 months)
- Frequency of Detection (Determined by NGS)(6-12 months)