China-Japan Friendship hospital
Beijing, Beijing Municipality, 100029, China
Not Yet Recruiting
NCT Number: NCT07472114
Effect of tNGS on CAP Patients With Initial Treatment Failure
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Targeted next-generation sequencing
Diagnostic TestBronchoalveolar 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.
Other names: tNGS test
Conventional microbiological testing
Diagnostic TestBronchoalveolar 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
Follow-up at Day 30
OtherA 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 outcomes
-
Length of hospital stay
Time frame: 30 days
Defined as the total number of hospital days by Day 30.
Secondary outcomes
-
30-day mortality
Time frame: 30 days
Defined as the proportion of patients who died by Day 30.
-
ICU admission rate
Time frame: 30 days
Defined as the incidence of transfer to the ICU within 30 days of randomization for patients initially admitted to a general ward.
-
Length of stay in ICU
Time frame: 30 days
Defined as the total number of days a patient spends in the ICU within 30 days of randomization
-
Incidence of mechanical ventilation
Time frame: 30 days
Defined as the proportion of patients receiving mechanical ventilation by day 30.
-
Duration of mechanical ventilation
Time frame: 30 days
Defined as the total number of days a patient receives mechanical ventilation within 30 days of randomization.
-
5-Day Antibiotic Modification Rate
Time frame: 5 days
Defined as the proportion of patients who undergo antibiotic escalation or de-escalation within 5 days after randomization.
-
3-Day Antibiotic Modification Rate
Time frame: 3 days
Defined as the proportion of patients who undergo antibiotic escalation or de-escalation within 3 days after randomization.
-
5-Day Other Antimicrobial Agents Modification Rate
Time frame: 5 days
Defined as the proportion of patients who initiate or discontinue other antimicrobial agents including antiviral, antifungal or antitubercular drugs within 5 days after randomization.
-
3-Day Other Antimicrobial Agents Modification Rate
Time frame: 3 days
Defined as the proportion of patients who initiate or discontinue other antimicrobial agents including antiviral, antifungal or antitubercular drugs within 3 days after randomization.
-
Cost of hospitalization
Time frame: 30 days
Defined as the total expenses incurred for hospitalization related to the current infection within 30 days of randomization."
Other outcomes
-
Pathogen detection rate
Time frame: 30 days
Defined as the rate of pathogen detection for the current infection.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Capital Medical University
Other
Collaborators
- Beijing Municipal Health Commission
- China-Japan Friendship Hospital
Registry information
Official study title
Impact of Targeted Next-generation Sequencing on Hospitalized Patients With Community-acquired Pneumonia and Initial Treatment Failure
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Mar 16, 2026
- Registry last updated
- Mar 16, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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