Detection and Characterization of Lower Respiratory Infec... | NCT01068990

Studies
Detection and Characterization of Lower Respiratory Infections in Critically Ill Patients

NCT01068990

Sponsor

Asan Medical Center

Status

Recruiting

Last Update Posted

Apr 18, 2024Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Severe Pneumonia

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Feb 28, 2028Estimated

Completion Date

Feb 28, 2028Estimated

First Submitted Date

Feb 12, 2010

First Submission Date that Met QC Criteria

Feb 16, 2010

First Posted Date

Feb 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2024

Last Update Posted Date

Apr 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a prospective observation study for lower respiratory tract infections in medical intensive care unit. Microbiologic and clinical characteristics and outcomes of patients with severe pneumonia in medical intensive care unit will be monitored and analyzed.

Detailed Description

All patients admitting medical ICU will be monitored for pneumonia. Both community-acquired (including health-care associated pneumonia) and hospital-acquired pneumonia will be included. Collecting data will include patient demographic characteristics, clinical features, microbiological characteristics including molecular work, and outcome.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identification of etiology of pneumonia		7 day from the time of pneumonia diagnosis

Secondary Outcomes

Measure	Description	Time Frame
Pneumonia-related death		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitting medical ICU with pneumonia
Medical ICU admitted patients who is developed new pneumonia

Exclusion Criteria:

Patients already treated more than 48 hours for pneumonia in transferring hospital and no causative organism is isolated

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients admitting or admitted in medical ICU with pneumonia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sang-Ho Choi, MD	Contact	+82-2-3010-3304		sangho@amc.seoul.kr

Overall Officials

Name	Affiliation	Role
Sang-Ho Choi, MD	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center	Recruiting	Seoul		138-736	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided