- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04279873
Use of Microscopy, Cultures and Molecular Biological Methods for Diagnosing Nosocomial Pneumonia
April 21, 2021 updated by: Zealand University Hospital
Use of Microscopy, Cultures and Molecular Biological Methods for Diagnosing Nosocomial Pneumonia in Patients Admitted to the Intensive Care Unit - an Exploratory Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
ICU patients fulfilling the CDC criteria for nosocomial pneumonia and mechanically ventilated for no more than 24 hours are included in the study.
The material for the diagnostic procedure is pulmonal secretion collected by 1. suctioning in the tracheal tube and 2. bronchioalveolar lavage.
The diagnostic procedures are culturing, 16S and18S gene PCR and subsequent sequencing.
The 3 diagnostic methods will be compared in order of proper diagnosis and the ability to determine a specific antimicrobial treatment.
Study Type
Observational
Enrollment (Actual)
22
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Region Sjælland
-
Køge, Region Sjælland, Denmark, 4600
- Zealand University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients with nosocomial pneumonia and the need of mechanical ventilation not intubated for more than 24 hours.
Description
Inclusion Criteria:
- Patients intubated because of respiratory failure following nosocomial pneumonia
Exclusion Criteria:
- Terminal patients
- Patients with lung cancer
- Intubated for more than 24 hours at the sampling time
- Not fulfilling the CDC criteria for nosocomial pneumonia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adults with nosocomial pneumonia
Diagnostic procedures on pulmonary secretion collected by tracheal suctioning and bronchoalveolar lavage.
|
Culture, 16s, 18s, next generation sequencing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ratio of patients where the advanced methods are superior to routine
Time Frame: 1 day
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lone Musaeus Poulsen, MD, Zealand University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2014
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
February 19, 2020
First Submitted That Met QC Criteria
February 19, 2020
First Posted (Actual)
February 21, 2020
Study Record Updates
Last Update Posted (Actual)
April 22, 2021
Last Update Submitted That Met QC Criteria
April 21, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REG-048-2014
- REG-48-2017 (Other Identifier: The Danish Data Protection Agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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