Corticosteroid Treatment for Community-Acquired Pneumonia to Improve Long-term Cognition: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Feasibility as determined by the number of subjects who are successfully recruited and complete follow-up
研究概览
简要总结
This is a single-center, blinded, placebo-controlled pilot RCT evaluating corticosteroids for the treatment of Community Acquired Pneumonia (CAP) that will enroll 100 adults hospitalized with community-acquired pneumonia. The primary goal is to assess the feasibility of proposed trial procedures for use in a subsequent phase III trial powered on 6-month cognitive outcome (MOCA-Blind score). Key outcomes are six-month cognitive and functional status, duration and severity of symptoms, and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years
- •Hospital admission to ward or ICU (including observation status admissions)
- •Acute pneumonia defined as fulfilling each of the following two criteria: (a) New (<7-day duration) or worsening symptoms consistent with a lower respiratory tract infection, including ≥ 1 of the following: cough, shortness of breath, chest pain, sputum production, or decline in mental status; (b) Radiographic findings on chest x-ray or CT consistent with acute pulmonary infection, including pulmonary opacities, infiltrates, or pleural effusion.
- •CRP ≥ 15 mg/dL within 24 hours of enrollment
排除标准
- •Systemic steroid use within the past 30-days.
- •Clinical team planning to treat with systemic steroids during this hospitalization independent of the study protocol.
- •Unable to randomize patient within 24 hours of hospital presentation.
- •Hospital-acquired pneumonia, defined as development of clinical and radiographic signs of pneumonia as an inpatient in an acute care hospital. (Residence in a nursing home or assisted living facility is not an exclusion criterion.)
- •Unable to follow simple commands or non-verbal prior to this acute illness.
- •Pre-existing severe dementia, defined as an Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score ≥ 4.
- •Concomitant acute decompensated heart failure requiring intravenous diuretics
- •Serum sodium > 145 mEq/L (hypernatremia) or potassium < 3.5 mEq/L (hypokalemia) at screening and randomization
- •Systolic blood pressure > 180 mmHg or a diastolic blood pressure > 100 mmHg at the start and end of screening.
- •Any history of diabetes mellitus, having a serum blood glucose > 250 mg/dL, or requiring an anti-diabetic medication (e.g., insulin)
- •Previous allergic or adverse reaction to a corticosteroid
- •Severe immunosuppression, defined as any of the following: HIV with CD4 count < 200 cells/mm3, absolute neutrophil count < 500 cells/mm3, solid organ or hematopoietic stem cell transplant with in the past 90 days.
- •Cystic fibrosis
- •Active cancer, defined as new diagnosis or treatment for cancer in the past 6 months.
- •Any history of adrenal insufficiency
- •Substance abuse (alcohol, opioid, benzodiazepines, methamphetamines, cocaine) within the past year
- •Any history of hospitalizations due to psychiatric illnesses within the past year
- •Gastro-intestinal bleeding treated with hospital admission and/or blood transfusion within the past 3 months.
- •Pre-existing medical condition resulting in a life expectancy < 6 months.
- •Clinical team does not believe the patient should enter the study due to concerns about potential steroid-related complications.
- •Alternative non-pneumonia illness accounts for the acute clinical or radiographic findings that meet the study's inclusion criteria.
- •Unable to take the enteral study medicine by mouth or tube
- •Prior enrollment in this study at any time
- •Non-English speaking
- •Confirmed or suspected COVID-19 as the cause of the patient's acute illness -
研究组 & 干预措施
Prednisone
Patients randomized to the intervention arm will receive prednisone 50mg PO daily for 7 days.
干预措施: Prednisone (Drug)
Placebo
Patients will receive matching placebo PO daily for 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Feasibility as determined by the number of subjects who are successfully recruited and complete follow-up
时间窗: 1.5 years
Feasibility will be defined as: (a) recruitment and successful protocol completion of 100 patients; (b) corticosteroids being well tolerated, as shown by similar severity and frequency of adverse events in the intervention and placebo groups; (c) successful completion of 6-month cognitive assessments by \>80% of survivors; and (d) the primary cognitive outcome Montreal Cognitive Assessment-Blind (MOCA-Blind) numerically favoring the intervention group with the one-tailed upper 80% confidence interval of the difference in MOCA-Blind between the intervention and placebo groups containing the minimally-important clinical difference (2 points on the MOCA-Blind).
次要结局
- Vital status (dead / alive)(6-months)
- Basic activities of daily living (ADL) as measured by the Barthel's Index(6-months)
- Severity of pneumonia symptoms as measured by the Community-Acquired Pneumonia Symptom (CAP-Sym) Questionnaire(30-days)
- Quality of life as measured by the EQ-5D-5L(6-months)
- Global cognition as measured by the Montreal Cognitive Assessment-Blind (MOCA-Blind)(6-months)
- Instrumental ADL as measured by Lawton Instrumental Activities of Daily Living Scale (IADLs)(6-months)
- Employment status as characterized by the Outcomes After Critical Illness and Surgery (OACIS) Employment Status Questionnaire(6-months)
- Mechanical ventilation (yes/no)(Baseline to hospital discharge, approximately 5 days)
- Pleural drainage (yes/no)(Baseline to hospital discharge, approximately 5 days)
- Hospital length of stay in (days)(Baseline to hospital discharge, approximately 5 days)
- Intensive care unit admission (yes/no)(Baseline to hospital discharge, approximately 5 days)
- Vasopressor use (yes/no)(Baseline to hospital discharge, approximately 5 days)
研究者
Jin H. Han
Associate Professor
Vanderbilt University Medical Center