Community Acquired Pneumonia (CAP)
Conditions
Keywords
targeted next generation sequencing, community acquired pneumonia, RCT, initial treatment failure
Brief 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.
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_TESTTargeted 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_TESTConventional 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
OTHERFollow-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.
Sponsors
Capital Medical University
China-Japan Friendship Hospital
Beijing Municipal Health Commission
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 30 days | Defined as the total number of hospital days by Day 30. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day mortality | 30 days | Defined as the proportion of patients who died by Day 30. |
| ICU admission rate | 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 | 30 days | Defined as the total number of days a patient spends in the ICU within 30 days of randomization |
| Incidence of mechanical ventilation | 30 days | Defined as the proportion of patients receiving mechanical ventilation by day 30. |
| Duration of mechanical ventilation | 30 days | Defined as the total number of days a patient receives mechanical ventilation within 30 days of randomization. |
| 5-Day Antibiotic Modification Rate | 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 | 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 | 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 | 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 | 30 days | Defined as the total expenses incurred for hospitalization related to the current infection within 30 days of randomization." |
Countries
China
Contacts
CONTACTYeming Wang, M.D.
CONTACTMengwei Yan
PRINCIPAL_INVESTIGATORBinghuai Lu, M.D.
China-Japan Friendship Hospital
STUDY_CHAIRBin Cao, M.D.
China-Japan Friendship Hospital
Outcome results
None listed