NCT01416506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 5, 2013

Status Verified

November 1, 2013

Enrollment Period

1.9 years

First QC Date

August 12, 2011

Last Update Submit

November 4, 2013

Conditions

Pneumonia

Keywords

Pneumonia, surveillance

Outcome Measures

Primary Outcomes (1)

  • In vitro Minimal Inhibitory Concentration Detection

    Up to 27 months

Secondary Outcomes (1)

  • In vitro Gene Mutation Detection

    Up to 15 months

Study Arms (1)

Group 1

Other: No Drug

Interventions

No DrugOTHER

It's a surveillance

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese adult (male or female) \>/= 18 years old

You may qualify if:

  • Chinese adult (male or female) ≥18 years old
  • Outpatients or inpatients who suffer from CAP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2011

First Posted

August 15, 2011

Study Start

September 1, 2010

Primary Completion

August 1, 2012

Study Completion

January 1, 2013

Last Updated

November 5, 2013

Record last verified: 2013-11

Locations

CN(1)