NCT02489578

Brief 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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

1.4 years

First QC Date

March 16, 2015

Last Update Submit

October 14, 2015

Conditions

Keywords

Community Acquired Pneumoniahealth care associated pneumonia

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    Time from date of admission to discharge up to 1 week

Secondary Outcomes (3)

  • Duration of intravenous antimicrobial therapy

    2 weeks

  • Hospital length of stay

    2 weeks

  • in-hospital mortality

    2 weeks

Interventions

otherOTHER

retrospective cohort study

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients \> or = 14 years of age
  • Patient meets the criteria of community acquired pneumonia
  • Patient meets the criteria of healthcare-associated pneumonia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, 100029, China

RECRUITING

Related Publications (7)

  • 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.

  • 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.

  • 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.

  • Han 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.

  • Han 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.

  • Han 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.

  • Chen 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 Links

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Bin Cao, MD

    China-Japan Friendship Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 16, 2015

First Posted

July 3, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 16, 2015

Record last verified: 2015-10

Locations