Effect of tNGS on CAP Patients With Initial Treatment Failure

Capital Medical University

Status: Begins enrollment this month

Conditions: Community Acquired Pneumonia (CAP)

Treatments: Diagnostic Test: Targeted next-generation sequencing; Diagnostic Test: Conventional microbiological testing; Other: Follow-up at Day 30

Study type: Interventional

Funder types: Other

Identifiers

NCT07472114

2024-1-4063

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 524 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (age ≥ 18 years)
• Diagnosed of community-acquired pneumonia
• Initial treatment failure

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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524 participants in 2 patient groups

tNGS group

Experimental group

Description:

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).

Treatment:

Other: Follow-up at Day 30

Diagnostic Test: Conventional microbiological testing

Diagnostic Test: Targeted next-generation sequencing

Control group

Active Comparator group

Description:

Lower respiratory tract samples collected (BALF, sputum); undergo conventional microbiological testing; follow-up by telephone on day 30 (D30).

Treatment:

Other: Follow-up at Day 30

Diagnostic Test: Conventional microbiological testing