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临床试验/NCT07472114
NCT07472114尚未招募不适用

Impact of Targeted Next-generation Sequencing on Hospitalized Patients With Community-acquired Pneumonia and Initial Treatment Failure

Capital Medical University1 个研究点 分布在 1 个国家目标入组 524 人开始时间: 2026年4月10日最近更新:
干预措施

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

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

Experimental

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

Experimental

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

Experimental

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

Active Comparator

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

Active Comparator

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

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bin Cao

Professor

China-Japan Friendship Hospital

研究点 (1)

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