Community Acquired PneumoniaCAP-ChinaNCT02492425
A Registry Study on Hospitalized Patients With Community-acquired Pneumonia in Real-life of 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 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
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to May 2018
- 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
- Informed consent to participate in the study is provided
Who cannot join
- Patients participating in a clinical trial or other intervention studies
- 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 （e.g. pulmonary embolism, pulmonary edema, pulmonary vasculitis, interstitial pneumonia）
- HIV positive
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, 100029
Bin Cao, MD, 86-010-84206264, caobin_ben@163.com
About this study
Official title: Evaluating the Adherence to Guidelines' Empirical Antibiotic Recommendations and Outcome of Patients Admitted to a Hospital Ward With a Diagnosis of Community-acquired Pneumonia
The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP and HCAP in real life of China
Read the detailed description
In China, the data about current management of patients hospitalized with community acquired pneumonia (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 healthcare associated pneumonia (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
- Keywords
- Community Acquired Pneumonia, Healthcare Associated Pneumonia
- Medical subject headings
- Community-Acquired Pneumonia, Healthcare-Associated Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
initial antibiotic treatment failure rate
a change in antibiotic therapy due to worsening signs or symptoms of infection or lack of clinical improvement after first dose use of antibiotics to 72h
Measured: 72 hours
in-hospital clinical failure rate
1)a change in antibiotic therapy due to worsening signs or symptoms of infection or lack of clinical improvement, 2) in-hospital mortality, 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
30-day post-discharge clinical failure rate
rate of re-hospitalization due to pulmonary infection and death during the follow-up period at 30 days post-discharge from hospital
Measured: discharge up to 5 weeks
Secondary outcomes (5)
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
Duration of oral antimicrobial therapy
Time from date of administration of first antibiotic to date of discontinuation of last antibiotic
Measured: 2 weeks
Duration of antimicrobial therapy
Time from date of administration of first antibiotic to date of discontinuation of last antibiotic (or to date of censoring, whichever comes first) upto a maximum of 30 days post-discharge from hospital post discharge from hospital
Measured: 6 weeks
Days of each antimicrobial therapy
Time from date of first administration on admission to hospital to date of discontinuation (or to date of censoring, whichever comes first) upto a maximum of 30 days post-discharge follow-up for each antibiotic
Measured: 6 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- 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
- NCT02492425
- Sponsor's protocol ID
- NCT20150401
- Acronym
- CAP-China
- Status last verified
- Oct 2015
- First submitted
- 16 Mar 2015
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
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 23578215
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Adherence to Guidelines' Empirical Antibiotic Recommendations and Outcome of Patients Admitted to a Hospital Ward With a Diagnosis of Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT02492425
- Acronym / sponsor ID
- CAP-China / NCT20150401
- Conditions
- Community Acquired Pneumonia
- Keywords
- Community Acquired Pneumonia, Healthcare Associated Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 8 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 HCAP in real life of China
Detailed description
In China, the data about current management of patients hospitalized with community acquired pneumonia (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 healthcare associated pneumonia (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
- Prospective
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 (4 listed)
- Patients > or = 14 years of age
- Patient meets the criteria of community acquired pneumonia
- Patient meets the criteria of healthcare-associated pneumonia
- Informed consent to participate in the study is provided
Key exclusion criteria (6 listed)
- Patients participating in a clinical trial or other intervention studies
- 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 （e.g. pulmonary embolism, pulmonary edema, pulmonary vasculitis, interstitial pneumonia）
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
initial antibiotic treatment failure rate
Time frame: 72 hours
a change in antibiotic therapy due to worsening signs or symptoms of infection or lack of clinical improvement after first dose use of antibiotics to 72h
in-hospital clinical failure rate
Time frame: Time from date of admission to discharge up to 1 week
1)a change in antibiotic therapy due to worsening signs or symptoms of infection or lack of clinical improvement, 2) in-hospital mortality, 3) recurrence, defined as signs or symptoms of infection after completion of therapy requiring re-initiation of antibiotics
30-day post-discharge clinical failure rate
Time frame: discharge up to 5 weeks
rate of re-hospitalization due to pulmonary infection and death during the follow-up period at 30 days post-discharge from hospital
5 secondary outcomes
Duration of intravenous antimicrobial therapy
Time frame: 2 weeks
Duration of oral antimicrobial therapy
Time frame: 2 weeks
Duration of antimicrobial therapy
Time frame: 6 weeks
Days of each antimicrobial therapy
Time frame: 6 weeks
Hospital length of stay
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 15 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Community Acquired Pneumonia
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Active, not recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Community-acquired Pneumonia, CAP
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 4 inclusion and 6 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 15 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?
initial antibiotic treatment failure rate (time frame: 72 hours). The study lists 3 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 NCT02492425, which also lists 3 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 15 Oct 2015.