Effect of tNGS on CAP Patients With Initial Treatment Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Targeted next-generation sequencing, Conventional microbiological testing, Follow-up at Day 30.
- Who it may be relevant to
- Registry conditions: Community Acquired Pneumonia (CAP). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Targeted Next-generation Sequencing on Hospitalized Patients With Community-acquired Pneumonia and Initial Treatment Failure
Overview
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.
Detailed 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.
Interventions
- Diagnostic test Targeted next-generation sequencing
Bronchoalveolar lavage fluid (BALF) or sputum samples will be collected within 72 hours after randomization and sent for targeted next-generation sequencing (tNGS). The test results will be reported to the attending physician within 1-2 days. - Diagnostic test Conventional microbiological testing
Bronchoalveolar lavage fluid (BALF) or sputum samples will be collected within 72 hours after randomization and sent for conventional microbiological testing. The type of conventional microbiological testing will be determined by the attending physician, and test results will be reported in approximately one week - Other Follow-up at Day 30
A telephone visit will be conducted on or around Day 30 for study participants who are discharged or transferred to another hospital due to disease exacerbation, to collect information on survival, ICU admissions, mechanical ventilation, and medical costs.
Primary outcome measures
- Length of hospital stay [Time frame: 30 days]
Secondary outcome measures (10)
- 30-day mortality [Time frame: 30 days]
- ICU admission rate [Time frame: 30 days]
- Length of stay in ICU [Time frame: 30 days]
- Incidence of mechanical ventilation [Time frame: 30 days]
- Duration of mechanical ventilation [Time frame: 30 days]
- 5-Day Antibiotic Modification Rate [Time frame: 5 days]
- 3-Day Antibiotic Modification Rate [Time frame: 3 days]
- 5-Day Other Antimicrobial Agents Modification Rate [Time frame: 5 days]
- 3-Day Other Antimicrobial Agents Modification Rate [Time frame: 3 days]
- Cost of hospitalization [Time frame: 30 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- China-Japan Friendship hospital — Beijing
Identifiers
NCT: NCT07472114 · 2024-1-4063