Community Acquired Pneumonia (CAP)NCT07472114
Effect of tNGS on CAP Patients With Initial Treatment Failure
A study testing Targeted next-generation sequencing, Conventional microbiological testing and Follow-up at Day 30 in people with Community Acquired Pneumonia (CAP), run by Capital Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia (CAP)
- What is being tested?
- Targeted next-generation sequencing, Conventional microbiological testing and Follow-up at Day 30
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age ≥ 18 years)
- Diagnosed of community-acquired pneumonia
- Initial treatment failure
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mengwei Yan contact
China1 site
China-Japan Friendship hospital
Beijing, Beijing Municipality, 100029
Bin Cao, +86 84206264, caobin_ben@163.com
About this study
Official title: Impact of Targeted Next-generation Sequencing on Hospitalized Patients With Community-acquired Pneumonia and 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.
Read the 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.
- Conditions
- Community Acquired Pneumonia (CAP)
- Being tested
- Targeted next-generation sequencing, Conventional microbiological testing, Follow-up at Day 30
- Keywords
- targeted next generation sequencing, community acquired pneumonia, RCT, initial treatment failure
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted next-generation sequencingDiagnostic test
Also called tNGS test
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.
Conventional microbiological testingDiagnostic test
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
Follow-up at Day 30Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Targeted next-generation sequencing; Diagnostic Test: Conventional microbiological testing; Other: Follow-up at Day 30 |
| Control group | Active comparator | Lower respiratory tract samples collected (BALF, sputum); undergo conventional microbiological testing; follow-up by telephone on day 30 (D30). Receives: Diagnostic Test: Conventional microbiological testing; Other: Follow-up at Day 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Defined as the total number of hospital days by Day 30.
Measured: 30 days
Secondary outcomes (10)
30-day mortality
Defined as the proportion of patients who died by Day 30.
Measured: 30 days
ICU admission rate
Defined as the incidence of transfer to the ICU within 30 days of randomization for patients initially admitted to a general ward.
Measured: 30 days
Length of stay in ICU
Defined as the total number of days a patient spends in the ICU within 30 days of randomization
Measured: 30 days
Incidence of mechanical ventilation
Defined as the proportion of patients receiving mechanical ventilation by day 30.
Measured: 30 days
Duration of mechanical ventilation
Defined as the total number of days a patient receives mechanical ventilation within 30 days of randomization.
Measured: 30 days
5-Day Antibiotic Modification Rate
Defined as the proportion of patients who undergo antibiotic escalation or de-escalation within 5 days after randomization.
Measured: 5 days
3-Day Antibiotic Modification Rate
Defined as the proportion of patients who undergo antibiotic escalation or de-escalation within 3 days after randomization.
Measured: 3 days
5-Day Other Antimicrobial Agents Modification Rate
Defined as the proportion of patients who initiate or discontinue other antimicrobial agents including antiviral, antifungal or antitubercular drugs within 5 days after randomization.
Measured: 5 days
3-Day Other Antimicrobial Agents Modification Rate
Defined as the proportion of patients who initiate or discontinue other antimicrobial agents including antiviral, antifungal or antitubercular drugs within 3 days after randomization.
Measured: 3 days
Cost of hospitalization
Defined as the total expenses incurred for hospitalization related to the current infection within 30 days of randomization."
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start10 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired Pneumonia (CAP)Studies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 524 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Beijing Municipal Health Commission
- Responsible party
- Principal investigator, Bin Cao, China-Japan Friendship Hospital
- Investigators
- Binghuai Lu, M.D., Principal investigator, China-Japan Friendship HospitalBin Cao, M.D., Study chair, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472114
- Sponsor's protocol ID
- 2024-1-4063
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Targeted Next-generation Sequencing on Hospitalized Patients With Community-acquired Pneumonia and Initial Treatment Failure
- ClinicalTrials.gov ID
- NCT07472114
- Acronym / sponsor ID
- 2024-1-4063
- Conditions
- Community Acquired Pneumonia (CAP)
- Keywords
- targeted next generation sequencing, community acquired pneumonia, RCT, initial treatment failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Beijing Municipal Health Commission
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tNGS group | Experimental | Diagnostic Test: Targeted next-generation sequencing, Diagnostic Test: Conventional microbiological testing, Other: Follow-up at Day 30Lower 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). |
| Control group | Active comparator | Diagnostic Test: Conventional microbiological testing, Other: Follow-up at Day 30Lower respiratory tract samples collected (BALF, sputum); undergo conventional microbiological testing; follow-up by telephone on day 30 (D30). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (age ≥ 18 years)
- Diagnosed of community-acquired pneumonia
- Initial treatment failure
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted next-generation sequencingAlso: tNGS 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. | Diagnostic test | tNGS group |
| Conventional microbiological testingBronchoalveolar 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 | Diagnostic test | Control group, tNGS group |
| Follow-up at Day 30A 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. | Other | Control group, tNGS group |
Primary outcome
Length of hospital stay
Time frame: 30 days
Defined as the total number of hospital days by Day 30.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Yes. IPD used in the results publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mengwei Yan contact
Binghuai Lu, M.D. principal investigator
China-Japan Friendship Hospital
Bin Cao, M.D. study chair
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted next-generation sequencing, Conventional microbiological testing and Follow-up at Day 30 in people with Community Acquired Pneumonia (CAP), run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeming Wang, M.D. (+86 84206264, wwyymm_love@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.