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Community-Acquired Pneumonia (CAP) Surveillance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01416506
First Posted: August 15, 2011
Last Update Posted: November 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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 ]

Secondary Outcome Measures:
  • In vitro Gene Mutation Detection [ Time Frame: Up to 15 months ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416506


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01416506     History of Changes
Other Study ID Numbers: 15465
NN1010CN ( Other Identifier: Company Internal )
First Submitted: August 12, 2011
First Posted: August 15, 2011
Last Update Posted: November 5, 2013
Last Verified: November 2013

Keywords provided by Bayer:
Pneumonia, surveillance

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