Severe PneumoniaNCT06538441
Dynamic Pattern of Etiology, Immunoinflammatory Factors and Their Association With Prognosis of Severe Pneumonia
An observational study of Severe Pneumonia, run by Shanghai General Hospital, China at 1 site in China.
Trial summary
The goal of this longitudinal observational study is to investigate the pathogen spectrum composition of severe pneumonia (SP) in different disease stages and to study the changes of immune inflammatory factors in patients with SP in different course of disease during and after the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Severe Pneumonia
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 Dec 2025
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Severe pneumonia patients admitted in ICU department in Shanghai General Hospital and respiratory-specific ICU department in the First Affiliated Hospital of Chongqing Medical University during June 1, 2022 to April 28, 2024.
Who may be able to join
- At least 18 years of age
- Clinical diagnosed of severe pneumonia (case definition: adults according to "Diagnosis and Treatment of Adults with Community-acquired Pneumonia"-- An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America, 2019)
- Have at least one microbiological test result
Who cannot join
- No data of clinical prognosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic Pattern of Etiology, Immunoinflammatory Factors and Their Association With Prognosis of Severe Pneumonia: a Longitudinal Observational Study
The goal of this longitudinal observational study is to investigate the pathogen spectrum composition of severe pneumonia (SP) in different disease stages and to study the changes of immune inflammatory factors in patients with SP in different course of disease during and after the COVID-19 pandemic. The main questions it aims to answer is:
What is the pathogenic profile of SP patient admitted in intensive care unit (ICU) during and after COVID-19 pandemic? What is the dynamic pattern of etiology and immunoinflammatory factors of SP progression during the period in ICU? Are those indexes mentioned above associated with the prognosis of SP?
Read the detailed description
This is a multi-center, longitudinal, observational study.
Participants
SP patients will be continuously recruited in ICU department in Shanghai General Hospital and respiratory-specific ICU (RICU) department in the First Affiliated Hospital of Chongqing Medical University during June 1, 2022 to December 31, 2024.
The investigators applied the AmericanThoracic Society(ATS)/Infectious Diseases Society of America (IDSA) major criteria to a cohort of patients hospitalized in two tertiary hospitals with severe pneumonia in order to describe its epidemiology, microbiology, and outcomes.
Assessment of disease progression
- Shock: Definition: A systemic pathological process in which the effective circulating blood volume is reduced due to various reasons and the tissue microcirculation perfusion is seriously insufficient, resulting in cell damage and serious dysfunction of function and metabolism of important organs. Overall arterial pressure decline: systolic blood pressure less than 90mmHg or mean arterial pressure (MAP) less than 70mmHg, accompanied by tachycardia. Clinical signs of hypoperfusion: skin damp cold with vasoconstriction and cyanosis; Kidney urine volume is less than 0.5ml/kg/h; The nervous system includes changes in mind (dullness of reaction, loss of orientation and confusion). Hyperlactacidemia: greater than 2mmol/L.
- Invasive mechanical ventilation: (1) Definition: Support of ventilation and improvement of oxygenation by inserting an intubation tube into the trachea and delivering warm, fully oxygenated, and moist gases to the airways and lungs at pressures above atmospheric pressure. (2) Classification: invasive ventilator-assisted ventilation under tracheal intubation, invasive ventilator-assisted ventilation under tracheal incision.
- High fever: body temperature (armpit temperature) exceeds 39 ° C. (Note: High fever is generally defined at 38.5℃ in clinical practice.)
- The above symptoms persist: shock for more than 3 days, high fever for more than 3 days, mechanical ventilation for more than 1 week.
Indicators
- Sociodemographic indexes: sex, age, personal history
- Clinical indicators: clinical diagnosis, past history, present history, treatment history, laboratory examination, clinical prognosis
- Laboratory examination : culture, species of infectious agent, antibiotic susceptibility test Microbiological etiological identification methods include: ① oral and pharyngeal swabs: polymerase chain reaction (PCR) for COVID-19 nucleic acid; ② Nasopharyngeal swab: PCR for influenza A virus nucleic acid; ③ Rectal swab: Macconkey plate + drug-sensitive paper was used to detect the presence of carbapenem-resistant gram-negative bacillus, and loop-mediated isothermal amplification was used to identify the presence of IPM, VIM, NDM, KPC, OXA and other resistance genes. ④ Smear: Various specimens are diluted and stained to observe whether there are bacteria and fungi and their morphology; ⑤ Culture: microbial culture of various specimens, and drug sensitivity test to determine drug resistance; ⑥ Quick test: Rapid detection of infectious diseases, including 17 bacteria and 7 fungi; ⑦ Immunofluorescence staining: Use fluorescein to label fungal cell wall, observe fungal morphology under fluorescence microscope for qualitative detection; ⑧ Next generation sequencing (NGS).
Other laboratory tests: Blood routine (white blood cell count, neutrophil count, lymphocyte count and neutrophil-to-lymphocyte ratio (NLR), C-reactive protein (CRP), procalcitonin (PCT)).
- Conditions
- Severe Pneumonia
- Keywords
- Pneumonia, Etiology, Inflammatory factor, Disease Progression, Prognosis
- Medical subject headings
- Pneumonia, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Severe pneumonia | Severe pneumonia patients will be continuously recruited in ICU department in Shanghai General Hospital (n=450) and RICU in the First Affiliated Hospital of Chongqing Medical University (n=150) during June 1, 2022 to April 28, 2024. Severe pneumonia was defined as meeting either one major criteria (septic shock with need of vasopressors or respiratory failure requiring mechanical ventilation) or three minor (laboratory and physiologic markers such as uremia or hypothermia) criteria according to the ATS/IDSA major criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Number of Participants with fatal outcomes out of all participants
Measured: up to 3 months
Secondary outcomes (2)
length of stay in ICU
Number of days since admitted to ICU for each patient
Measured: through study completion, an average of 38 days
duration of mechanical ventilation
Number of days of mechanical ventilation treatment for each patient
Measured: through study completion, an average of 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Aug 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Severe PneumoniaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Kang, Shanghai General Hospital, China
- Investigators
- Mei Kang, MPH, Principal investigator, Clinical Research Center, Shanghai General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538441
- Sponsor's protocol ID
- 2024023
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used in this study are available upon request to the principle investigator.
Publications
Drigot ZG, Clark SE. Insights into the role of the respiratory tract microbiome in defense against bacterial pneumonia. Curr Opin Microbiol. 2024 Feb;77:102428. doi: 10.1016/j.mib.2024.102428. Epub 2024 Jan 25.
PubMed 38277901Azoulay E, Russell L, Van de Louw A, Metaxa V, Bauer P, Povoa P, Montero JG, Loeches IM, Mehta S, Puxty K, Schellongowski P, Rello J, Mokart D, Lemiale V, Mirouse A; Nine-i Investigators. Diagnosis of severe respiratory infections in immunocompromised patients. Intensive Care Med. 2020 Feb;46(2):298-314. doi: 10.1007/s00134-019-05906-5. Epub 2020 Feb 7.
PubMed 32034433Natalini JG, Singh S, Segal LN. The dynamic lung microbiome in health and disease. Nat Rev Microbiol. 2023 Apr;21(4):222-235. doi: 10.1038/s41579-022-00821-x. Epub 2022 Nov 16.
PubMed 36385637Shi Y, Huang Y, Zhang TT, Cao B, Wang H, Zhuo C, Ye F, Su X, Fan H, Xu JF, Zhang J, Lai GX, She DY, Zhang XY, He B, He LX, Liu YN, Qu JM. Chinese guidelines for the diagnosis and treatment of hospital-acquired pneumonia and ventilator-associated pneumonia in adults (2018 Edition). J Thorac Dis. 2019 Jun;11(6):2581-2616. doi: 10.21037/jtd.2019.06.09. No abstract available.
PubMed 31372297Simon L, Gauvin F, Amre DK, Saint-Louis P, Lacroix J. Serum procalcitonin and C-reactive protein levels as markers of bacterial infection: a systematic review and meta-analysis. Clin Infect Dis. 2004 Jul 15;39(2):206-17. doi: 10.1086/421997. Epub 2004 Jul 2.
PubMed 15307030Xie Y, Du J, Jin W, Teng X, Cheng R, Huang P, Xie H, Zhou Z, Tian R, Wang R, Feng T. Next generation sequencing for diagnosis of severe pneumonia: China, 2010-2018. J Infect. 2019 Feb;78(2):158-169. doi: 10.1016/j.jinf.2018.09.004. Epub 2018 Sep 18. No abstract available.
PubMed 30237069Kelly BJ, Imai I, Bittinger K, Laughlin A, Fuchs BD, Bushman FD, Collman RG. Composition and dynamics of the respiratory tract microbiome in intubated patients. Microbiome. 2016 Feb 11;4:7. doi: 10.1186/s40168-016-0151-8.
PubMed 26865050Yang L, Haidar G, Zia H, Nettles R, Qin S, Wang X, Shah F, Rapport SF, Charalampous T, Methe B, Fitch A, Morris A, McVerry BJ, O'Grady J, Kitsios GD. Metagenomic identification of severe pneumonia pathogens in mechanically-ventilated patients: a feasibility and clinical validity study. Respir Res. 2019 Nov 27;20(1):265. doi: 10.1186/s12931-019-1218-4.
PubMed 31775777Huang WC, Wu MF, Huang CC, Liu SY, Chen HC, Chen YY, Hsu JY, Huang CC. Dynamics of the lung microbiome in intensive care patients with chronic obstructive pulmonary disease and community-acquired pneumonia. Sci Rep. 2020 Jul 6;10(1):11046. doi: 10.1038/s41598-020-68100-4.
PubMed 32632240Shi N, Huang C, Zhang Q, Shi C, Liu F, Song F, Hou Q, Shen J, Shan F, Su X, Liu C, Zhang Z, Shi L, Shi Y. Longitudinal trajectories of pneumonia lesions and lymphocyte counts associated with disease severity among convalescent COVID-19 patients: a group-based multi-trajectory analysis. BMC Pulm Med. 2021 Jul 13;21(1):233. doi: 10.1186/s12890-021-01592-6.
PubMed 34256743Lin MJ, Rachleff VM, Xie H, Shrestha L, Lieberman NAP, Peddu V, Addetia A, Casto AM, Breit N, Mathias PC, Huang ML, Jerome KR, Greninger AL, Roychoudhury P. Host-pathogen dynamics in longitudinal clinical specimens from patients with COVID-19. Sci Rep. 2022 Apr 7;12(1):5856. doi: 10.1038/s41598-022-09752-2.
PubMed 35393464File TM Jr, Ramirez JA. Community-Acquired Pneumonia. N Engl J Med. 2023 Aug 17;389(7):632-641. doi: 10.1056/NEJMcp2303286. No abstract available.
PubMed 37585629Xie L, Luo G, Yang Z, Wu WC, Chen J, Ren Y, Zeng Z, Ye G, Pan Y, Zhao WJ, Chen YQ, Hou W, Sun Y, Guo D, Yang Z, Li J, Holmes EC, Li Y, Chen L, Shi M. The clinical outcome of COVID-19 is strongly associated with microbiome dynamics in the upper respiratory tract. J Infect. 2024 Mar;88(3):106118. doi: 10.1016/j.jinf.2024.01.017. Epub 2024 Feb 10.
PubMed 38342382Perez-Cobas AE, Baquero F, de Pablo R, Soriano MC, Coque TM. Altered Ecology of the Respiratory Tract Microbiome and Nosocomial Pneumonia. Front Microbiol. 2022 Feb 10;12:709421. doi: 10.3389/fmicb.2021.709421. eCollection 2021.
PubMed 35222291
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Pattern of Etiology, Immunoinflammatory Factors and Their Association With Prognosis of Severe Pneumonia: a Longitudinal Observational Study
- ClinicalTrials.gov ID
- NCT06538441
- Acronym / sponsor ID
- 2024023
- Conditions
- Severe Pneumonia
- Keywords
- Pneumonia, Etiology, Inflammatory factor, Disease Progression, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, ChinaUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Chongqing Medical University
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 5 Aug 2024 (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.
The goal of this longitudinal observational study is to investigate the pathogen spectrum composition of severe pneumonia (SP) in different disease stages and to study the changes of immune inflammatory factors in patients with SP in different course of disease during and after the COVID-19 pandemic. The main questions it aims to answer is:
What is the pathogenic profile of SP patient admitted in intensive care unit (ICU) during and after COVID-19 pandemic? What is the dynamic pattern of etiology and immunoinflammatory factors of SP progression during the period in ICU? Are those indexes mentioned above associated with the prognosis of SP?
Detailed description
This is a multi-center, longitudinal, observational study.
Participants
SP patients will be continuously recruited in ICU department in Shanghai General Hospital and respiratory-specific ICU (RICU) department in the First Affiliated Hospital of Chongqing Medical University during June 1, 2022 to December 31, 2024.
The investigators applied the AmericanThoracic Society(ATS)/Infectious Diseases Society of America (IDSA) major criteria to a cohort of patients hospitalized in two tertiary hospitals with severe pneumonia in order to describe its epidemiology, microbiology, and outcomes.
Assessment of disease progression
- Shock: Definition: A systemic pathological process in which the effective circulating blood volume is reduced due to various reasons and the tissue microcirculation perfusion is seriously insufficient, resulting in cell damage and serious dysfunction of function and metabolism of important organs. Overall arterial pressure decline: systolic blood pressure less than 90mmHg or mean arterial pressure (MAP) less than 70mmHg, accompanied by tachycardia. Clinical signs of hypoperfusion: skin damp cold with vasoconstriction and cyanosis; Kidney urine volume is less than 0.5ml/kg/h; The nervous system includes changes in mind (dullness of reaction, loss of orientation and confusion). Hyperlactacidemia: greater than 2mmol/L.
- Invasive mechanical ventilation: (1) Definition: Support of ventilation and improvement of oxygenation by inserting an intubation tube into the trachea and delivering warm, fully oxygenated, and moist gases to the airways and lungs at pressures above atmospheric pressure. (2) Classification: invasive ventilator-assisted ventilation under tracheal intubation, invasive ventilator-assisted ventilation under tracheal incision.
- High fever: body temperature (armpit temperature) exceeds 39 ° C. (Note: High fever is generally defined at 38.5℃ in clinical practice.)
- The above symptoms persist: shock for more than 3 days, high fever for more than 3 days, mechanical ventilation for more than 1 week.
Indicators
- Sociodemographic indexes: sex, age, personal history
- Clinical indicators: clinical diagnosis, past history, present history, treatment history, laboratory examination, clinical prognosis
- Laboratory examination : culture, species of infectious agent, antibiotic susceptibility test Microbiological etiological identification methods include: ① oral and pharyngeal swabs: polymerase chain reaction (PCR) for COVID-19 nucleic acid; ② Nasopharyngeal swab: PCR for influenza A virus nucleic acid; ③ Rectal swab: Macconkey plate + drug-sensitive paper was used to detect the presence of carbapenem-resistant gram-negative bacillus, and loop-mediated isothermal amplification was used to identify the presence of IPM, VIM, NDM, KPC, OXA and other resistance genes. ④ Smear: Various specimens are diluted and stained to observe whether there are bacteria and fungi and their morphology; ⑤ Culture: microbial culture of various specimens, and drug sensitivity test to determine drug resistance; ⑥ Quick test: Rapid detection of infectious diseases, including 17 bacteria and 7 fungi; ⑦ Immunofluorescence staining: Use fluorescein to label fungal cell wall, observe fungal morphology under fluorescence microscope for qualitative detection; ⑧ Next generation sequencing (NGS).
Other laboratory tests: Blood routine (white blood cell count, neutrophil count, lymphocyte count and neutrophil-to-lymphocyte ratio (NLR), C-reactive protein (CRP), procalcitonin (PCT)).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe pneumonia | – | –Severe pneumonia patients will be continuously recruited in ICU department in Shanghai General Hospital (n=450) and RICU in the First Affiliated Hospital of Chongqing Medical University (n=150) during June 1, 2022 to April 28, 2024. Severe pneumonia was defined as meeting either one major criteria (septic shock with need of vasopressors or respiratory failure requiring mechanical ventilation) or three minor (laboratory and physiologic markers such as uremia or hypothermia) criteria according to the ATS/IDSA major criteria. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Severe pneumonia patients admitted in ICU department in Shanghai General Hospital and respiratory-specific ICU department in the First Affiliated Hospital of Chongqing Medical University during June 1, 2022 to April 28, 2024.
Key inclusion criteria (3 listed)
- At least 18 years of age
- Clinical diagnosed of severe pneumonia (case definition: adults according to "Diagnosis and Treatment of Adults with Community-acquired Pneumonia"-- An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America, 2019)
- Have at least one microbiological test result
Key exclusion criteria (1 listed)
- No data of clinical prognosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital mortality
Time frame: up to 3 months
Number of Participants with fatal outcomes out of all participants
2 secondary outcomes
length of stay in ICU
Time frame: through study completion, an average of 38 days
duration of mechanical ventilation
Time frame: through study completion, an average of 25 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 38277901Drigot ZG, Clark SE. Insights into the role of the respiratory tract microbiome in defense against bacterial pneumonia. Curr Opin Microbiol. 2024 Feb;77:102428. doi: 10.1016/j.mib.2024.102428. Epub 2024 Jan 25.
- Background: PubMed 32034433Azoulay E, Russell L, Van de Louw A, Metaxa V, Bauer P, Povoa P, Montero JG, Loeches IM, Mehta S, Puxty K, Schellongowski P, Rello J, Mokart D, Lemiale V, Mirouse A; Nine-i Investigators. Diagnosis of severe respiratory infections in immunocompromised patients. Intensive Care Med. 2020 Feb;46(2):298-314. doi: 10.1007/s00134-019-05906-5. Epub 2020 Feb 7.
- Background: PubMed 36385637Natalini JG, Singh S, Segal LN. The dynamic lung microbiome in health and disease. Nat Rev Microbiol. 2023 Apr;21(4):222-235. doi: 10.1038/s41579-022-00821-x. Epub 2022 Nov 16.
- Background: PubMed 31372297Shi Y, Huang Y, Zhang TT, Cao B, Wang H, Zhuo C, Ye F, Su X, Fan H, Xu JF, Zhang J, Lai GX, She DY, Zhang XY, He B, He LX, Liu YN, Qu JM. Chinese guidelines for the diagnosis and treatment of hospital-acquired pneumonia and ventilator-associated pneumonia in adults (2018 Edition). J Thorac Dis. 2019 Jun;11(6):2581-2616. doi: 10.21037/jtd.2019.06.09. No abstract available.
- Background: PubMed 15307030Simon L, Gauvin F, Amre DK, Saint-Louis P, Lacroix J. Serum procalcitonin and C-reactive protein levels as markers of bacterial infection: a systematic review and meta-analysis. Clin Infect Dis. 2004 Jul 15;39(2):206-17. doi: 10.1086/421997. Epub 2004 Jul 2.
- Background: PubMed 30237069Xie Y, Du J, Jin W, Teng X, Cheng R, Huang P, Xie H, Zhou Z, Tian R, Wang R, Feng T. Next generation sequencing for diagnosis of severe pneumonia: China, 2010-2018. J Infect. 2019 Feb;78(2):158-169. doi: 10.1016/j.jinf.2018.09.004. Epub 2018 Sep 18. No abstract available.
- Background: PubMed 26865050Kelly BJ, Imai I, Bittinger K, Laughlin A, Fuchs BD, Bushman FD, Collman RG. Composition and dynamics of the respiratory tract microbiome in intubated patients. Microbiome. 2016 Feb 11;4:7. doi: 10.1186/s40168-016-0151-8.
- Background: PubMed 31775777Yang L, Haidar G, Zia H, Nettles R, Qin S, Wang X, Shah F, Rapport SF, Charalampous T, Methe B, Fitch A, Morris A, McVerry BJ, O'Grady J, Kitsios GD. Metagenomic identification of severe pneumonia pathogens in mechanically-ventilated patients: a feasibility and clinical validity study. Respir Res. 2019 Nov 27;20(1):265. doi: 10.1186/s12931-019-1218-4.
- Background: PubMed 32632240Huang WC, Wu MF, Huang CC, Liu SY, Chen HC, Chen YY, Hsu JY, Huang CC. Dynamics of the lung microbiome in intensive care patients with chronic obstructive pulmonary disease and community-acquired pneumonia. Sci Rep. 2020 Jul 6;10(1):11046. doi: 10.1038/s41598-020-68100-4.
- Background: PubMed 34256743Shi N, Huang C, Zhang Q, Shi C, Liu F, Song F, Hou Q, Shen J, Shan F, Su X, Liu C, Zhang Z, Shi L, Shi Y. Longitudinal trajectories of pneumonia lesions and lymphocyte counts associated with disease severity among convalescent COVID-19 patients: a group-based multi-trajectory analysis. BMC Pulm Med. 2021 Jul 13;21(1):233. doi: 10.1186/s12890-021-01592-6.
- Background: PubMed 35393464Lin MJ, Rachleff VM, Xie H, Shrestha L, Lieberman NAP, Peddu V, Addetia A, Casto AM, Breit N, Mathias PC, Huang ML, Jerome KR, Greninger AL, Roychoudhury P. Host-pathogen dynamics in longitudinal clinical specimens from patients with COVID-19. Sci Rep. 2022 Apr 7;12(1):5856. doi: 10.1038/s41598-022-09752-2.
- Background: PubMed 37585629File TM Jr, Ramirez JA. Community-Acquired Pneumonia. N Engl J Med. 2023 Aug 17;389(7):632-641. doi: 10.1056/NEJMcp2303286. No abstract available.
- Individual participant dataSharing planned: Undecided. The datasets used in this study are available upon request to the principle investigator.
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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.
Mei Kang, MPH principal investigator
Clinical Research Center, Shanghai General Hospital
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 Severe Pneumonia, run by Shanghai General Hospital, China 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 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 7 Aug 2024. 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?
In-hospital mortality (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06538441, which also lists 14 linked publications.
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 7 Aug 2024.