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

Community Acquired Pneumonia Clinical Trial

— CAP-China  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02492425
• Other study ID #: NCT20150401
• Status: Not yet recruiting
• Phase: N/A
• First received: March 16, 2015
• Last updated: October 14, 2015
• Start date: January 2016
• Est. completion date: May 2018

Study information

• Verified date: October 2015
• Source: Capital Medical University
• Contact: Bin Cao, MD
• Phone: 86-010-84206264
• Email: caobin_ben[@]163.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: May 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Pneumonia

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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 pneu — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	2 weeks	No
Secondary	Duration of oral antimicrobial therapy	Time from date of administration of first antibiotic to date of discontinuation of last antibiotic	2 weeks	No
Secondary	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	6 weeks	No
Secondary	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	6 weeks	No
Secondary	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	2 weeks	No

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