Pathogenic Microorganism of Serious PneumoniaNCT04433403
Pathogenic Microorganisms in Adult Severe Pneumonia Patients
An observational study of Pathogenic Microorganism of Serious Pneumonia, run by Shengjing Hospital at 1 site in China.
Trial summary
This study aimed to evaluate pathogenic microorganisms in adult severe pneumonia patients in different cities of Liaoning Province Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathogenic Microorganism of Serious Pneumonia
- What is being tested?
- pathogenic microorganism
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 30 Jun 2024
- 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: Severe pneumonia patients, aged 18 years and above, gender unlimited.
Who may be able to join
- Meet the standard of severe pneumonia： Main standards： Requiring mechanical ventilation or septic shock requiring vasoconstrictor therapy.
- Secondary standards：(only if 3 items are met) Disturbance of consciousness; respiratory rate ≥ 30 times/min; PaO2/FiO2 ≤ 250, or PaO2 < 60mmHg; azotemia (BUN ≥ 7.12mmol / L); hypotension requires strong fluid resuscitation; infiltration of multiple lobes; leucopenia (WBC < 4 × 109 / L); thrombocytopenia (< 10 × 109 / L); hypothermia (T < 36 ℃).
Who cannot join
- refuse to sign informed consent; inaccurate results due to unqualified sputum or BALF samples
Trial locations and contacts
1 site in 1 country.
China1 site
Shengjing hospital of China Medical University
Shenyang, Liaoning, 110004
About this study
Official title: A Multicenter Clinical Study on the Detection of Pathogenic Microorganisms in Adult Severe Pneumonia Patients in Liaoning Province
This study aimed to evaluate pathogenic microorganisms in adult severe pneumonia patients in different cities of Liaoning Province
Read the detailed description
The pathogenic microorganisms of adult patients with severe pneumonia is detected in this study. Clinical treatment does not involve , so it meets the ethical requirements. The clinical data, laboratory test results and imaging data of adult severe pneumonia patients in different hospitals in different cities are recorded. The pathogenic microorganism is detected by second-generation sequencing of lower respiratory tract sputum or alveolar lavage fluid samples, and the data were sorted out to draw the pathogenic microorganism spectrum of adult severe pneumonia in Liaoning area. It will be used to guide clinical empirical treatment.
- Being tested
- pathogenic microorganism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pathogenic microorganismOther
Detection of pathogenic microorganisms in adult severe pneumonia by second generation sequencing
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathogenic microorganism spectrum of adult severe pneumonia in Liaoning Province
Detection of pathogenic microorganisms in severe pneumonia by second generation sequencing
Measured: 2020.7-2023.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathogenic Microorganism of Serious PneumoniaStudies of the same condition, open and under way.
- More trials run by Shengjing 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 only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chaoyang Central Hospital, Yingkou Central Hospital, Huludao central hospital, Dandong First Hospital, Fushun Mining Bureau General Hospital, Benxi Cental Hospital
- Responsible party
- Principal investigator, Hongyu Zhao, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433403
- Sponsor's protocol ID
- PMASP
- Status last verified
- Sep 2021
- First submitted
- 13 Jun 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study on the Detection of Pathogenic Microorganisms in Adult Severe Pneumonia Patients in Liaoning Province
- ClinicalTrials.gov ID
- NCT04433403
- Acronym / sponsor ID
- PMASP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Collaborators
- Chaoyang Central Hospital, Yingkou Central Hospital, Huludao central hospital, Dandong First Hospital, Fushun Mining Bureau General Hospital, Benxi Cental Hospital
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 16 Jun 2020 (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 study aimed to evaluate pathogenic microorganisms in adult severe pneumonia patients in different cities of Liaoning Province
Detailed description
The pathogenic microorganisms of adult patients with severe pneumonia is detected in this study. Clinical treatment does not involve , so it meets the ethical requirements. The clinical data, laboratory test results and imaging data of adult severe pneumonia patients in different hospitals in different cities are recorded. The pathogenic microorganism is detected by second-generation sequencing of lower respiratory tract sputum or alveolar lavage fluid samples, and the data were sorted out to draw the pathogenic microorganism spectrum of adult severe pneumonia in Liaoning area. It will be used to guide clinical empirical treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe pneumonia patients, aged 18 years and above, gender unlimited.
Key inclusion criteria (2 listed)
- Meet the standard of severe pneumonia： Main standards： Requiring mechanical ventilation or septic shock requiring vasoconstrictor therapy.
- Secondary standards：(only if 3 items are met) Disturbance of consciousness; respiratory rate ≥ 30 times/min; PaO2/FiO2 ≤ 250, or PaO2 < 60mmHg; azotemia (BUN ≥ 7.12mmol / L); hypotension requires strong fluid resuscitation; infiltration of multiple lobes; leucopenia (WBC < 4 × 109 / L); thrombocytopenia (< 10 × 109 / L); hypothermia (T < 36 ℃).
Key exclusion criteria (1 listed)
- refuse to sign informed consent; inaccurate results due to unqualified sputum or BALF samples
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 |
|---|---|---|
| pathogenic microorganismDetection of pathogenic microorganisms in adult severe pneumonia by second generation sequencing | Other | – |
Primary outcome
Pathogenic microorganism spectrum of adult severe pneumonia in Liaoning Province
Time frame: 2020.7-2023.12
Detection of pathogenic microorganisms in severe pneumonia by second generation sequencing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pathogenic Microorganism of Serious Pneumonia, run by Shengjing Hospital 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Sep 2021. 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?
Results are not available in the source record.
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?
Pathogenic microorganism spectrum of adult severe pneumonia in Liaoning Province (time frame: 2020.7-2023.12). 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 22 Sep 2021.