Community-Acquired Pneumonia (CAP) Surveillance

This study is currently recruiting participants.

Verified May 2013 by Bayer

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT01416506

First received: August 12, 2011

Last updated: May 8, 2013

Last verified: May 2013

History of Changes

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:

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

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

Estimated Enrollment:	560
Study Start Date:	September 2010
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (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

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

China
	Recruiting
Many Locations, China

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Director, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT01416506 History of Changes
Other Study ID Numbers:	15465, NN1010CN
Study First Received:	August 12, 2011
Last Updated:	May 8, 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 May 23, 2013

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