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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014