Community-Acquired Pneumonia (CAP) Surveillance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01416506
First received: August 12, 2011
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

Prospective, non-interventional, multi-center study. 7 investigative centers will involved in China. Around 560 CAP outpatients or inpatients will be screened until 56 M. pneumoniae isolates collected.


Condition Intervention
Pneumonia
Other: No Drug

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Community-Acquired Pneumonia (CAP) Mycoplasma Surveillance

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • In vitro Minimal Inhibitory Concentration Detection [ Time Frame: Up to 27 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In vitro Gene Mutation Detection [ Time Frame: Up to 15 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum


Enrollment: 560
Study Start Date: September 2010
Study Completion Date: January 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Other: No Drug
It's a surveillance

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chinese adult (male or female) >/= 18 years old

Criteria

Inclusion Criteria:

  • Chinese adult (male or female) ≥18 years old
  • Outpatients or inpatients who suffer from CAP

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416506

Locations
China
Many Locations, China
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01416506     History of Changes
Other Study ID Numbers: 15465, NN1010CN
Study First Received: August 12, 2011
Last Updated: November 4, 2013
Health Authority: China: Ethics committee of the General Hospital of the People's Liberation Army

Keywords provided by Bayer:
Pneumonia, surveillance

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 17, 2014