NCT04279873

Brief Summary

Nosocomial pneumonia in the Intensive Care Unit is often not properly diagnosed mainly due to ongoing antimicrobial therapy. The study investigates the feasibility of more advanced diagnostic technics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2014

Longer than P75 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

May 1, 2014

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

6.7 years

First QC Date

February 19, 2020

Last Update Submit

April 21, 2021

Conditions

Nosocomial Pneumonia

Keywords

Nosocomial, PneumoniaDiagnostics16s18sPCRNext Generation Sequencing

Outcome Measures

Primary Outcomes (1)

  • Ratio of patients where the advanced methods are superior to routine

    Ratio of patients diagnosed by 16s, 18s or NGS to total number of patients compared to ratio of patients diagnosed by routine method (culture)

    1 day

Study Arms (1)

Adults with nosocomial pneumonia

Diagnostic procedures on pulmonary secretion collected by tracheal suctioning and bronchoalveolar lavage.

Diagnostic Test: Microbiological diagnostics on pulmonary secretion

Interventions

Microbiological diagnostics on pulmonary secretionDIAGNOSTIC_TEST

Culture, 16s, 18s, next generation sequencing

Adults with nosocomial pneumonia

Eligibility Criteria

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

Adult patients with nosocomial pneumonia and the need of mechanical ventilation not intubated for more than 24 hours.

You may qualify if:

  • Patients intubated because of respiratory failure following nosocomial pneumonia

You may not qualify if:

  • Terminal patients
  • Patients with lung cancer
  • Intubated for more than 24 hours at the sampling time
  • Not fulfilling the CDC criteria for nosocomial pneumonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Køge, Region Sjælland, 4600, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Pulmonary secretion

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Cross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lone Musaeus Poulsen, MD

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 21, 2020

Study Start

May 1, 2014

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 22, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)