Effect of tNGS on CAP Patients With Initial Treatment Failure

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (age ≥ 18 years)

Diagnosed of community-acquired pneumonia

Initial treatment failure

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Targeted next-generation sequencing

    Diagnostic 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 testing

    Diagnostic 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 30

    Other intervention

    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.

Treatment groups

524 Participants
are divided into 2 treatment groups
Group A: tNGS groupExperimental treatment 3 interventions
Group B: Control groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Length of hospital stay

Defined as the total number of hospital days by Day 30.

Time frame
30 days

Secondary outcomes

1

30-day mortality

Defined as the proportion of patients who died by Day 30.

Time frame
30 days
2

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.

Time frame
30 days
3

Length of stay in ICU

Defined as the total number of days a patient spends in the ICU within 30 days of randomization

Time frame
30 days
4

Incidence of mechanical ventilation

Defined as the proportion of patients receiving mechanical ventilation by day 30.

Time frame
30 days

Other outcomes

1

Pathogen detection rate

Defined as the rate of pathogen detection for the current infection.

Time frame
30 days

Sponsors and contacts

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Capital Medical University

Lead sponsor

China-Japan Friendship Hospital

Sponsor institution

China-Japan Friendship Hospital

Collaborator

Beijing Municipal Health Commission

Collaborator

This trial is not recruiting at the moment. You can still explore other options: