NCT02492425

Brief Summary

The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP and 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 Jan 2016

Typical duration for all trials

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

First Posted

Study publicly available on registry

July 8, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

11 months

First QC Date

March 16, 2015

Last Update Submit

October 14, 2015

Conditions

Community Acquired Pneumonia

Keywords

Community Acquired PneumoniaHealthcare Associated Pneumonia

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    discharge up to 5 weeks

Secondary Outcomes (5)

  • Duration of intravenous antimicrobial therapy

    2 weeks

  • Duration of oral antimicrobial therapy

    2 weeks

  • Duration of antimicrobial therapy

    6 weeks

  • Days of each antimicrobial therapy

    6 weeks

  • Hospital length of stay

    2 weeks

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
  • Informed consent to participate in the study is provided

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, 100029, China

Location

Related Publications (3)

  • 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.

    PMID: 24106842RESULT

  • 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.

    PMID: 24551881RESULT

  • 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.

    PMID: 23578215RESULT

Related Links

MeSH Terms

Conditions

Community-Acquired PneumoniaHealthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract DiseasesCross InfectionLung DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bin Cao, MD

    China-Japan Friendship Hospital

    STUDY CHAIR

Central Study Contacts

Bin Cao, MD

CONTACT

86-010-84206264caobin_ben@163.com

LI Gu, MD

CONTACT

86-010-85231514guli2013227@foxmail.com.cn

Study Design

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

Study Record Dates

First Submitted

March 16, 2015

First Posted

July 8, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

May 1, 2018

Last Updated

October 15, 2015

Record last verified: 2015-10

Locations

CN(1)