Impact of Targeted Next-generation Sequencing on Hospitalized Patients With Community-acquired Pneumonia and Initial Treatment Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 524
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
This is a multicenter, randomized controlled trial designed to evaluate the impact of tNGS in patients with community-acquired pneumonia who experience initial treatment failure.
详细描述
Community-acquired pneumonia (CAP) is a common respiratory disease and poses a major threat to global health. CAP can be caused by a wide range of respiratory pathogens, including viruses, bacteria, and fungi. However, conventional microbiological tests often fail to identify the causative pathogens, making etiological diagnosis challenging and limiting the implementation of individualized treatment strategies, which may affect patient prognosis.
Targeted next-generation sequencing (tNGS) enables the simultaneous detection of hundreds of common respiratory pathogens at a relatively low cost and has significantly improved pathogen detection rates. To further evaluate the impact of tNGS on clinical decision-making and patient outcomes in real-world practice, a multicenter randomized controlled trial is proposed by the investigators, enrolling patients with community-acquired pneumonia who experience initial treatment failure. Participants will be randomly assigned in a 1:1 ratio to either the tNGS group or the conventional testing group. Patients in the tNGS group will undergo tNGS in addition to conventional microbiological testing, whereas those in the conventional testing group will receive conventional microbiological testing alone. Length of hospital stay and other clinical effectiveness endpoints will be compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (age ≥ 18 years)
- •Diagnosed of community-acquired pneumonia
- •Initial treatment failure
排除标准
- •tNGS or mNGS already performed on respiratory samples during the current illness
- •Suspected lung abscess or empyema
- •Cerebral infarction within the past three months
- •Dysphagia
- •Nasopharyngeal carcinoma currently receiving radiotherapy
- •Tracheostomy
- •Long-term bedridden patients (ADL score ≤ 60)
- •Pathogens identified within the past 7 days that adequately explain the current clinical presentation
- •Bronchiectasis with large amounts of sputum and documented bacterial detection within the past six months
- •Inability to obtain eligible respiratory samples
- •CURB-65 score ≤ 1
- •Expected discharge or death within 48 hours
研究组 & 干预措施
tNGS group
Lower respiratory tract samples collected (BALF, sputum); undergo targeted next-generation sequencing in addition to conventional microbiological testing; follow-up by telephone on day 30 (D30).
干预措施: Targeted next-generation sequencing (Diagnostic Test)
tNGS group
Lower respiratory tract samples collected (BALF, sputum); undergo targeted next-generation sequencing in addition to conventional microbiological testing; follow-up by telephone on day 30 (D30).
干预措施: Conventional microbiological testing (Diagnostic Test)
tNGS group
Lower respiratory tract samples collected (BALF, sputum); undergo targeted next-generation sequencing in addition to conventional microbiological testing; follow-up by telephone on day 30 (D30).
干预措施: Follow-up at Day 30 (Other)
Control group
Lower respiratory tract samples collected (BALF, sputum); undergo conventional microbiological testing; follow-up by telephone on day 30 (D30).
干预措施: Conventional microbiological testing (Diagnostic Test)
Control group
Lower respiratory tract samples collected (BALF, sputum); undergo conventional microbiological testing; follow-up by telephone on day 30 (D30).
干预措施: Follow-up at Day 30 (Other)
结局指标
主要结局
Length of hospital stay
时间窗: 30 days
Defined as the total number of hospital days by Day 30.
次要结局
- 30-day mortality(30 days)
- ICU admission rate(30 days)
- Length of stay in ICU(30 days)
- Incidence of mechanical ventilation(30 days)
- Duration of mechanical ventilation(30 days)
- 5-Day Antibiotic Modification Rate(5 days)
- 3-Day Antibiotic Modification Rate(3 days)
- 5-Day Other Antimicrobial Agents Modification Rate(5 days)
- 3-Day Other Antimicrobial Agents Modification Rate(3 days)
- Cost of hospitalization(30 days)
研究者
Bin Cao
Professor
China-Japan Friendship Hospital
