NCT00935285

Brief Summary

Ventilator-associated pneumonia (VAP) is very common in the intensive care unit (ICU), affecting 9 to 40% of ICU patients and mortality rates range from 20 to 50% and may reach more than 70% when the infection is caused by multi-resistant and invasive pathogens. The most common pathogens that cause VAP are the Gram(-) bacteria. Findings indicate that TLRs serves as an important signal in the generation of protective innate responses to bacterial pathogens of the lung and that is required for effective innate immune responses against Gram-negative bacterial pathogens. There is genetic evidence that mutations in TLRs increase the risk of developing nosocomial infections. Understanding the TLR system should offer invaluable opportunity for manipulating host immune responses.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

July 9, 2009

Status Verified

July 1, 2009

Enrollment Period

2.1 years

First QC Date

July 8, 2009

Last Update Submit

July 8, 2009

Conditions

Keywords

Ventilator-associated pneumonia (VAP)Intensive care unit (ICU)Toll-like receptors

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include ICU patients who receive mechanical ventilation \<48h and have no history of ΑRDS or other respiratory disease.

You may qualify if:

  • Presence in intensive care unit receive mechanical ventilation \<48h have no history of ΑRDS or other respiratory disease

You may not qualify if:

  • Length of stay \<24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zakynthinos

Larissa, Mezourlo, 41335, Greece

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sofia Sarafi RN MSc, ICU

    University Hospital Larisa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2009

First Posted

July 9, 2009

Study Start

July 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

July 9, 2009

Record last verified: 2009-07

Locations