NCT07116382

Brief Summary

The aim of the study is to compare cases of ventilator-associated pneumonia with matched controls of mechanically ventilated patients to identify any relevant independent risk factors for ventilator-associated pneumonia. All adult (≥ 18 years) mechanically ventilated patients \> 48 hours who are diagnosed with ventilator-associated pneumonia are considered as cases. The control group are mechanically ventilated patients and matching with cases regarding their age, gender, and duration of mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 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

February 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

August 2, 2025

Last Update Submit

August 8, 2025

Conditions

Keywords

Critical CareVentilator Associated PneumoniaRisk Factors

Outcome Measures

Primary Outcomes (1)

  • In-ICU mortality

    All-Cause Mortality Rate

    Up to ICU discharge for a maximum of 3 months

Study Arms (2)

VAP group

All adult (≥ 18 years) mechanically ventilated patients \> 48 hours who are diagnosed with ventilator-associated pneumonia are considered as cases. All possible risk factors for VAP are investigated.

Matched Control group

Mechanically ventilated (≥ 48 hours) patients and matching with cases regarding their age, gender, and duration of MV. All possible risk factors for VAP are investigated.

Eligibility Criteria

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

Adults diagnosed with VAP (cases group) and matched controls without VAP.

You may qualify if:

  • All adult (≥ 18 years) mechanically ventilated patients \> 48 hours who are diagnosed with VAP (Case Group).
  • The control group is mechanically ventilated (≥ 48 hours) patients and matched with cases regarding their gender, age, and duration of MV.

You may not qualify if:

  • Patients with pneumonia prior to MV and those developing pneumonia within 48 hours are excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AMUH

Alexandria, Egypt

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 Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher, Public Health and Community Medicine Department

Study Record Dates

First Submitted

August 2, 2025

First Posted

August 11, 2025

Study Start

February 20, 2025

Primary Completion

May 20, 2025

Study Completion

May 20, 2025

Last Updated

August 11, 2025

Record last verified: 2025-08

Locations