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

October 14, 2015 updated by: Bin Cao, Capital Medical University

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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100029
        • China-Japan Friendship Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
72 hours
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
Time from date of admission to discharge up to 1 week
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
discharge up to 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of intravenous antimicrobial therapy
Time Frame: 2 weeks
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
Hospital length of stay
Time Frame: 2 weeks
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
Duration of oral antimicrobial therapy
Time Frame: 2 weeks
Time from date of administration of first antibiotic to date of discontinuation of last antibiotic
2 weeks
Duration of antimicrobial therapy
Time Frame: 6 weeks
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
Days of each antimicrobial therapy
Time Frame: 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Investigators

  • Study Chair: Bin Cao, MD, China-Japan Friendship Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

March 16, 2015

First Submitted That Met QC Criteria

July 5, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Estimate)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT20150401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Community Acquired Pneumonia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe