CAPNCT04959955
Project to Improve the Diagnosis and Treatment Ability of Adult Severe Community Acquired Lower Respiratory Tract Infection
An observational study of CAP and COPD Exacerbation, run by Peking University Third Hospital.
Trial summary
1. Objective to understand the proportion of atypical pathogens in the pathogens of SCAP and AECOPD in urban hospitals in China. 2. Objective to investigate the antimicrobial resistance of atypical pathogens in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) and SCAP in urban… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CAP, COPD Exacerbation
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 8 Aug 2015to 12 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult hospitalized cases of SCAP and acute exacerbation of COPD were collected from 12 medical institutions in 10 cities in China within 2 years.
Who may be able to join
- SCAP
- AECOPD
Who cannot join
- Pregnant or lactating women.
- Patients with bronchiectasis.
- Patients with active pulmonary tuberculosis.
- Aspiration pneumonia or obstructive pneumonia.
- Two weeks before the onset of hospital treatment history, this infection can not be excluded from hospital acquired infection.
- HIV positive patients (but HIV testing is not required).
- Patients who are unable and / or unable to understand and / or implement the investigation protocol.
About this study
- Objective to understand the proportion of atypical pathogens in the pathogens of SCAP and AECOPD in urban hospitals in China.
- Objective to investigate the antimicrobial resistance of atypical pathogens in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) and SCAP in urban hospitals.
- Objective to master the important clinical characteristics of patients with acute exacerbation of SCAP and COPD caused by atypical pathogens and mixed infection in urban hospitals in China, and to put forward the experience judgment index.
- Objective to evaluate the advantages of various diagnostic methods for atypical pathogens causing lower respiratory tract infection.
- It is suggested that the current empirical treatment of SCAP and severe COPD in China should be improved.
- Conditions
- CAP, COPD Exacerbation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| AECOPD group | Not described | |
| CAP group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of atypical pathogens and mixed infections
Incidence of atypical pathogens and mixed infections
Measured: 2year Incidence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start8 Aug 2015
- Primary completion10 Jul 2016
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAPStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of China Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959955
- Sponsor's protocol ID
- LM2016057
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project to Improve the Diagnosis and Treatment Ability of Adult Severe Community Acquired Lower Respiratory Tract Infection
- ClinicalTrials.gov ID
- NCT04959955
- Acronym / sponsor ID
- LM2016057
- Conditions
- CAP, COPD Exacerbation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- First Hospital of China Medical University
- Study start
- 8 Aug 2015 (actual)
- Primary completion
- 10 Jul 2016 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 13 Jul 2021 (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.
- Objective to understand the proportion of atypical pathogens in the pathogens of SCAP and AECOPD in urban hospitals in China.
- Objective to investigate the antimicrobial resistance of atypical pathogens in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) and SCAP in urban hospitals.
- Objective to master the important clinical characteristics of patients with acute exacerbation of SCAP and COPD caused by atypical pathogens and mixed infection in urban hospitals in China, and to put forward the experience judgment index.
- Objective to evaluate the advantages of various diagnostic methods for atypical pathogens causing lower respiratory tract infection.
- It is suggested that the current empirical treatment of SCAP and severe COPD in China should be improved.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AECOPD group | – | – |
| CAP group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult hospitalized cases of SCAP and acute exacerbation of COPD were collected from 12 medical institutions in 10 cities in China within 2 years.
Key inclusion criteria (2 listed)
- SCAP
- AECOPD
Key exclusion criteria (7 listed)
- Pregnant or lactating women.
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 |
|---|---|---|
| Diagnostic test | AECOPD group, CAP group |
Primary outcome
Incidence of atypical pathogens and mixed infections
Time frame: 2year Incidence
Incidence of atypical pathogens and mixed infections
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of CAP and COPD Exacerbation, run by Peking University Third Hospital.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of atypical pathogens and mixed infections (time frame: 2year Incidence). 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 13 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.