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Community-Acquired Pneumonia (CAP) Surveillance

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ClinicalTrials.gov Identifier: NCT01416506
Recruitment Status : Completed
First Posted : August 15, 2011
Last Update Posted : November 5, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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 or disease Intervention/treatment
Pneumonia Other: No Drug

Study Type : Observational
Actual Enrollment : 560 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Community-Acquired Pneumonia (CAP) Mycoplasma Surveillance
Study Start Date : September 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1 Other: No Drug
It's a surveillance



Primary Outcome Measures :
  1. In vitro Minimal Inhibitory Concentration Detection [ Time Frame: Up to 27 months ]

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

Biospecimen Retention:   Samples With DNA
whole blood, serum


Information from the National Library of Medicine

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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:


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01416506     History of Changes
Other Study ID Numbers: 15465
NN1010CN ( Other Identifier: Company Internal )
First Posted: August 15, 2011    Key Record Dates
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