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NCT01416506 Clinical Trial

Community-Acquired Pneumonia (CAP) Surveillance

Pneumonia Clinical Trial

Official title:
Community-Acquired Pneumonia (CAP) Mycoplasma Surveillance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01416506
Other study ID # 15465
Secondary ID NN1010CN
Status Completed
Phase N/A
First received August 12, 2011
Last updated November 4, 2013
Start date September 2010
Est. completion date January 2013

Study information
Verified date November 2013
Source Bayer
Contact n/a
Is FDA regulated No
Health authority China: Ethics committee of the General Hospital of the People's Liberation Army
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 560
Est. completion date January 2013
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Chinese adult (male or female) =18 years old

- Outpatients or inpatients who suffer from CAP

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• No Drug
It's a surveillance

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary In vitro Minimal Inhibitory Concentration Detection Up to 27 months No
Secondary In vitro Gene Mutation Detection Up to 15 months No
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