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Status unknownNCT02492425CAP-ChinaUpdated Oct 15, 2015

A Registry Study on Hospitalized Patients With Community-acquired Pneumonia in Real-life of China

An observational study in Community Acquired Pneumonia, sponsored by Capital Medical University. Status unknown at 1 site in China. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2015-10-15.

Sponsored by Capital Medical University · Observational

The sponsor has not verified this record recently (last verified Oct 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
14 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Community Acquired Pneumonia

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Keywords

  • Community Acquired Pneumonia
  • Healthcare Associated Pneumonia
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In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

3000 patients with community acquired pneumonia who meet the below inclusion/ exclusion criteria will be recruited in China

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

    Time frame: 72 hours

  2. 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

    Time frame: Time from date of admission to discharge up to 1 week

  3. 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

    Time frame: discharge up to 5 weeks

Secondary outcomes

  1. 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

    Time frame: 2 weeks

  2. Duration of oral antimicrobial therapy

    Time from date of administration of first antibiotic to date of discontinuation of last antibiotic

    Time frame: 2 weeks

  3. 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

    Time frame: 6 weeks

  4. 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

    Time frame: 6 weeks

  5. 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

    Time frame: 2 weeks

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Study locations

1 site
  • China-Japan Friendship Hospital
    Beijing, 100029, China
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References and documents

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 24106842 ↗
  • Cao 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 24551881 ↗
  • Qu 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02492425
Lead sponsor
Capital Medical University
Responsible party
Bin Cao (MD, Capital Medical University) — Principal investigator
First posted
Jul 8, 2015
Start date
Jan 2016
Primary completion
Dec 2016 (estimated)
Completion
May 2018 (estimated)
Last update
Oct 15, 2015

Study contacts

Bin Cao, MD
Contact
caobin_ben@163.com
86-010-84206264
LI Gu, MD
Contact
guli2013227@foxmail.com.cn
86-010-85231514
Bin Cao, MD
study chair · China-Japan Friendship Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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