Community Acquired PneumoniaRSCAP-ChinaNCT02489578
A Retrospective Study on Hospitalized Patients With Community-acquired Pneumonia in China (CAP-China)
An observational study of Community Acquired Pneumonia, run by Capital Medical University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP and healthcare-associated pneumonia (HCAP) in real life of China . Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- other
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Dec 2016
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 3000 patients with community acquired pneumonia who meet the below inclusion/ exclusion criteria will be recruited in China.
Who may be able to join
- Patients > or = 14 years of age
- Patient meets the criteria of community acquired pneumonia
- Patient meets the criteria of healthcare-associated pneumonia
Who cannot join
- Patients <14 years of age
- Patient meets the criteria of hospital acquired pneumonia
- Known active tuberculosis or current treatment for tuberculosis
- Non-infectious pulmonary diseases
- HIV positive
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, 100029
Bin Cao, MD, 86-010-84206264, caobin_ben@163.com
Li Gu, MD, 86-010-85231514, guli2013227@foxmail.com.cn
About this study
Official title: Management in Real-life of Patients Hospitalized With Community-acquired Pneumonia in China
The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP and healthcare-associated pneumonia (HCAP) in real life of China .
Read the detailed description
In China, the data about current management of patients hospitalized with CAP in the real-life setting is not available,type of pneumonia, selection of initial antibiotic, time to clinical stability, antibiotic choice anf modification,clinical outcomes and costs remain unclear.
In this study, we will collect comprehensive information on CAP and HCAP management patterns to evaluate the disease burden of hospitalized patients with CAP and HCAP in real life of China .to analyze microbiological characteristics,clinical manifestations,antibiotic regimens ,adherences to guidelines and effect on outcome in different groups of patients with CAP (> and = 65 years, different comorbidities ,risk factors) ,to investigate microbiological characteristics,clinical manifestations,antibiotic regimens ,adherences to guidelines and effect on outcome in different groups of disease severity with CAP ,to provide the difference on microbiological characteristics,clinical manifestations,antibiotic regimens ,and outcome between patients with CAP and HCAP ,to understand the current situation of antibiotic regimen ,to evaluate influence of different antibiotic regimens on prognosis.
- Conditions
- Community Acquired Pneumonia
- Being tested
- other
- Keywords
- Community Acquired Pneumonia, health care associated pneumonia
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
otherOther
retrospective cohort study
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment failure at 72h after initiation of antibiotics
treatment failure was defined as a change of antibiotics due to worsening signs or symptoms associated with pneumonia
Measured: Time from the first dose use of antibiotics to 72 hours
in-hospital treatment failure due to multiple causes
1)death in hospital;2)change of antibiotics due to worsening signs or symptoms of infection, 3) recurrence, defined as signs or symptoms of infection after completion of therapy requiring re-initiation of antibiotics
Measured: Time from date of admission to discharge up to 1 week
Secondary outcomes (3)
Duration of intravenous antimicrobial therapy
Time from the first dose of intravenous antibiotics to date of stop of intravenous antibiotics ,participants will be followed for the duration of hospital stay
Measured: 2 weeks
Hospital length of stay
Patients will be asked about hospitalization, date, Patients will be asked about hospitalization, date, participants will be asked about the time of admission and discharge
Measured: 2 weeks
in-hospital mortality
Time from date of admission to date of discharge,participants will be followed for the duration of hospital stay
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Jishuitan Hospital, Beijing Luhe Hospital, Qingdao Municipal Hospital, Qilu Hospital of Shandong University, Beijing Huimin Hospital, China-Japan Friendship Hospital, Linzi Hospital, Second Hospital of Beijing Armed Police Corps, Kunming Yan'an Hospital
- Responsible party
- Principal investigator, Bin Cao, Capital Medical University
- Investigators
- Bin Cao, MD, Study chair, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489578
- Sponsor's protocol ID
- NCT20150101
- Acronym
- RSCAP-China
- Status last verified
- Oct 2015
- First submitted
- 16 Mar 2015
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang SQ, Qu JX, Wang C, Yu XM, Liu YM, Cao B. Influenza pneumonia among adolescents and adults: a concurrent comparison between influenza A (H1N1) pdm09 and A (H3N2) in the post-pandemic period. Clin Respir J. 2014 Apr;8(2):185-91. doi: 10.1111/crj.12056. Epub 2013 Nov 26.
PubMed 24106842Cao B, Huang GH, Pu ZH, Qu JX, Yu XM, Zhu Z, Dong JP, Gao Y, Zhang YX, Li XH, Liu JH, Wang H, Xu Q, Li H, Xu W, Wang C. Emergence of community-acquired adenovirus type 55 as a cause of community-onset pneumonia. Chest. 2014 Jan;145(1):79-86. doi: 10.1378/chest.13-1186.
PubMed 24551881Qu J, Gu L, Wu J, Dong J, Pu Z, Gao Y, Hu M, Zhang Y, Gao F, Cao B, Wang C; Beijing Network for Adult Community-Acquired Pneumonia (BNACAP). Accuracy of IgM antibody testing, FQ-PCR and culture in laboratory diagnosis of acute infection by Mycoplasma pneumoniae in adults and adolescents with community-acquired pneumonia. BMC Infect Dis. 2013 Apr 11;13:172. doi: 10.1186/1471-2334-13-172.
PubMed 23578215Han X, Wang H, Chen L, Wang Y, Li H, Zhou F, Xing X, Zhang C, Suo L, Wang J, Yu G, Wang G, Yao X, Yu H, Wang L, Liu M, Xue C, Liu B, Zhu X, Li Y, Xiao Y, Cui X, Li L, Liu X, Cao B. Impact of inhaled corticosteroid use on elderly chronic pulmonary disease patients with community acquired pneumonia. Chin Med J (Engl). 2024 Jan 20;137(2):241-243. doi: 10.1097/CM9.0000000000002936. Epub 2023 Dec 20. No abstract available.
PubMed 38111015Han X, Liu X, Chen L, Wang Y, Li H, Zhou F, Xing X, Zhang C, Suo L, Wang J, Yu G, Wang G, Yao X, Yu H, Wang L, Liu M, Xue C, Liu B, Zhu X, Li Y, Xiao Y, Cui X, Li L, Cao B; CAP-China network. Disease burden and prognostic factors for clinical failure in elderly community acquired pneumonia patients. BMC Infect Dis. 2020 Sep 12;20(1):668. doi: 10.1186/s12879-020-05362-3.
PubMed 32919458Han X, Zhou F, Li H, Xing X, Chen L, Wang Y, Zhang C, Liu X, Suo L, Wang J, Yu G, Wang G, Yao X, Yu H, Wang L, Liu M, Xue C, Liu B, Zhu X, Li Y, Xiao Y, Cui X, Li L, Purdy JE, Cao B; CAP-China network. Effects of age, comorbidity and adherence to current antimicrobial guidelines on mortality in hospitalized elderly patients with community-acquired pneumonia. BMC Infect Dis. 2018 Apr 24;18(1):192. doi: 10.1186/s12879-018-3098-5.
PubMed 29699493Chen L, Zhou F, Li H, Xing X, Han X, Wang Y, Zhang C, Suo L, Wang J, Yu G, Wang G, Yao X, Yu H, Wang L, Liu M, Xue C, Liu B, Zhu X, Li Y, Xiao Y, Cui X, Li L, Uyeki TM, Wang C, Cao B; CAP-China network. Disease characteristics and management of hospitalised adolescents and adults with community-acquired pneumonia in China: a retrospective multicentre survey. BMJ Open. 2018 Feb 15;8(2):e018709. doi: 10.1136/bmjopen-2017-018709.
PubMed 29449294
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management in Real-life of Patients Hospitalized With Community-acquired Pneumonia in China
- ClinicalTrials.gov ID
- NCT02489578
- Acronym / sponsor ID
- RSCAP-China / NCT20150101
- Conditions
- Community Acquired Pneumonia
- Keywords
- Community Acquired Pneumonia, health care associated pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Jishuitan Hospital, Beijing Luhe Hospital, Qingdao Municipal Hospital, Qilu Hospital of Shandong University, Beijing Huimin Hospital, China-Japan Friendship Hospital, Linzi Hospital, Second Hospital of Beijing Armed Police Corps, Kunming Yan'an Hospital
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 3 Jul 2015 (estimated)
- 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 purpose of this study is to evaluate the disease burden of hospitalized patients with CAP and healthcare-associated pneumonia (HCAP) in real life of China .
Detailed description
In China, the data about current management of patients hospitalized with CAP in the real-life setting is not available,type of pneumonia, selection of initial antibiotic, time to clinical stability, antibiotic choice anf modification,clinical outcomes and costs remain unclear.
In this study, we will collect comprehensive information on CAP and HCAP management patterns to evaluate the disease burden of hospitalized patients with CAP and HCAP in real life of China .to analyze microbiological characteristics,clinical manifestations,antibiotic regimens ,adherences to guidelines and effect on outcome in different groups of patients with CAP (> and = 65 years, different comorbidities ,risk factors) ,to investigate microbiological characteristics,clinical manifestations,antibiotic regimens ,adherences to guidelines and effect on outcome in different groups of disease severity with CAP ,to provide the difference on microbiological characteristics,clinical manifestations,antibiotic regimens ,and outcome between patients with CAP and HCAP ,to understand the current situation of antibiotic regimen ,to evaluate influence of different antibiotic regimens on prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 3000 patients with community acquired pneumonia who meet the below inclusion/ exclusion criteria will be recruited in China.
Key inclusion criteria (3 listed)
- Patients > or = 14 years of age
- Patient meets the criteria of community acquired pneumonia
- Patient meets the criteria of healthcare-associated pneumonia
Key exclusion criteria (5 listed)
- Patients <14 years of age
- Patient meets the criteria of hospital acquired pneumonia
- Known active tuberculosis or current treatment for tuberculosis
- Non-infectious pulmonary diseases
- HIV positive
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 |
|---|---|---|
| otherretrospective cohort study | Other | – |
Primary outcome
treatment failure at 72h after initiation of antibiotics
Time frame: Time from the first dose use of antibiotics to 72 hours
treatment failure was defined as a change of antibiotics due to worsening signs or symptoms associated with pneumonia
in-hospital treatment failure due to multiple causes
Time frame: Time from date of admission to discharge up to 1 week
1)death in hospital;2)change of antibiotics due to worsening signs or symptoms of infection, 3) recurrence, defined as signs or symptoms of infection after completion of therapy requiring re-initiation of antibiotics
3 secondary outcomes
Duration of intravenous antimicrobial therapy
Time frame: 2 weeks
Hospital length of stay
Time frame: 2 weeks
in-hospital mortality
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
- Results publication: PubMed 24106842Yang SQ, Qu JX, Wang C, Yu XM, Liu YM, Cao B. Influenza pneumonia among adolescents and adults: a concurrent comparison between influenza A (H1N1) pdm09 and A (H3N2) in the post-pandemic period. Clin Respir J. 2014 Apr;8(2):185-91. doi: 10.1111/crj.12056. Epub 2013 Nov 26.
- Results publication: PubMed 24551881Cao B, Huang GH, Pu ZH, Qu JX, Yu XM, Zhu Z, Dong JP, Gao Y, Zhang YX, Li XH, Liu JH, Wang H, Xu Q, Li H, Xu W, Wang C. Emergence of community-acquired adenovirus type 55 as a cause of community-onset pneumonia. Chest. 2014 Jan;145(1):79-86. doi: 10.1378/chest.13-1186.
- Results publication: PubMed 23578215Qu J, Gu L, Wu J, Dong J, Pu Z, Gao Y, Hu M, Zhang Y, Gao F, Cao B, Wang C; Beijing Network for Adult Community-Acquired Pneumonia (BNACAP). Accuracy of IgM antibody testing, FQ-PCR and culture in laboratory diagnosis of acute infection by Mycoplasma pneumoniae in adults and adolescents with community-acquired pneumonia. BMC Infect Dis. 2013 Apr 11;13:172. doi: 10.1186/1471-2334-13-172.
- Derived from this study: PubMed 38111015Han X, Wang H, Chen L, Wang Y, Li H, Zhou F, Xing X, Zhang C, Suo L, Wang J, Yu G, Wang G, Yao X, Yu H, Wang L, Liu M, Xue C, Liu B, Zhu X, Li Y, Xiao Y, Cui X, Li L, Liu X, Cao B. Impact of inhaled corticosteroid use on elderly chronic pulmonary disease patients with community acquired pneumonia. Chin Med J (Engl). 2024 Jan 20;137(2):241-243. doi: 10.1097/CM9.0000000000002936. Epub 2023 Dec 20. No abstract available.
- Derived from this study: PubMed 32919458Han X, Liu X, Chen L, Wang Y, Li H, Zhou F, Xing X, Zhang C, Suo L, Wang J, Yu G, Wang G, Yao X, Yu H, Wang L, Liu M, Xue C, Liu B, Zhu X, Li Y, Xiao Y, Cui X, Li L, Cao B; CAP-China network. Disease burden and prognostic factors for clinical failure in elderly community acquired pneumonia patients. BMC Infect Dis. 2020 Sep 12;20(1):668. doi: 10.1186/s12879-020-05362-3.
- Derived from this study: PubMed 29699493Han X, Zhou F, Li H, Xing X, Chen L, Wang Y, Zhang C, Liu X, Suo L, Wang J, Yu G, Wang G, Yao X, Yu H, Wang L, Liu M, Xue C, Liu B, Zhu X, Li Y, Xiao Y, Cui X, Li L, Purdy JE, Cao B; CAP-China network. Effects of age, comorbidity and adherence to current antimicrobial guidelines on mortality in hospitalized elderly patients with community-acquired pneumonia. BMC Infect Dis. 2018 Apr 24;18(1):192. doi: 10.1186/s12879-018-3098-5.
- Derived from this study: PubMed 29449294Chen L, Zhou F, Li H, Xing X, Han X, Wang Y, Zhang C, Suo L, Wang J, Yu G, Wang G, Yao X, Yu H, Wang L, Liu M, Xue C, Liu B, Zhu X, Li Y, Xiao Y, Cui X, Li L, Uyeki TM, Wang C, Cao B; CAP-China network. Disease characteristics and management of hospitalised adolescents and adults with community-acquired pneumonia in China: a retrospective multicentre survey. BMJ Open. 2018 Feb 15;8(2):e018709. doi: 10.1136/bmjopen-2017-018709.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Bin Cao, MD study chair
China-Japan Friendship 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 Community Acquired Pneumonia, run by Capital Medical University 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 5 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 16 Oct 2015. 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?
Contact Bin Cao, MD (86-010-84206264, caobin_ben@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment failure at 72h after initiation of antibiotics (time frame: Time from the first dose use of antibiotics to 72 hours). The study lists 2 primary outcomes in all. 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 NCT02489578, which also lists 7 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 16 Oct 2015.