Nosocomial PneumoniaNCT04279873
Use of Microscopy, Cultures and Molecular Biological Methods for Diagnosing Nosocomial Pneumonia
An observational study of Nosocomial Pneumonia, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nosocomial Pneumonia
- What is being tested?
- Microbiological diagnostics on pulmonary secretion
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2014to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with nosocomial pneumonia and the need of mechanical ventilation not intubated for more than 24 hours.
Who may be able to join
- Patients intubated because of respiratory failure following nosocomial pneumonia
Who cannot join
- Terminal patients
- Patients with lung cancer
- Intubated for more than 24 hours at the sampling time
- Not fulfilling the CDC criteria for nosocomial pneumonia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nosocomial Pneumonia
- Being tested
- Microbiological diagnostics on pulmonary secretion
- Keywords
- Nosocomial, Pneumonia, Diagnostics, 16s, 18s, PCR, Next Generation Sequencing
- Medical subject headings
- Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiological diagnostics on pulmonary secretionDiagnostic test
Culture, 16s, 18s, next generation sequencing
| Study group | Role | What they receive |
|---|---|---|
| Adults with nosocomial pneumonia | Diagnostic procedures on pulmonary secretion collected by tracheal suctioning and bronchoalveolar lavage. Receives: Diagnostic Test: Microbiological diagnostics on pulmonary secretion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 May 2014
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nosocomial PneumoniaStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Slagelse Hospital
- Responsible party
- Sponsor
- Investigators
- Lone Musaeus Poulsen, MD, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279873
- Sponsor's protocol ID
- REG-048-2014
- Other IDs
- REG-48-2017
- Status last verified
- Apr 2021
- First submitted
- 19 Feb 2020
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Microscopy, Cultures and Molecular Biological Methods for Diagnosing Nosocomial Pneumonia in Patients Admitted to the Intensive Care Unit - an Exploratory Study
- ClinicalTrials.gov ID
- NCT04279873
- Acronym / sponsor ID
- REG-048-2014
- Conditions
- Nosocomial Pneumonia
- Keywords
- Nosocomial, Pneumonia, Diagnostics, 16s, 18s, PCR, Next Generation Sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Slagelse Hospital
- Study start
- 1 May 2014 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with nosocomial pneumonia | – | Diagnostic Test: Microbiological diagnostics on pulmonary secretionDiagnostic procedures on pulmonary secretion collected by tracheal suctioning and bronchoalveolar lavage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with nosocomial pneumonia and the need of mechanical ventilation not intubated for more than 24 hours.
Key inclusion criteria (1 listed)
- Patients intubated because of respiratory failure following nosocomial pneumonia
Key exclusion criteria (4 listed)
- Terminal patients
- Patients with lung cancer
- Intubated for more than 24 hours at the sampling time
- Not fulfilling the CDC criteria for nosocomial pneumonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiological diagnostics on pulmonary secretionCulture, 16s, 18s, next generation sequencing | Diagnostic test | Adults with nosocomial pneumonia |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lone Musaeus Poulsen, MD principal investigator
Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nosocomial Pneumonia, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of patients where the advanced methods are superior to routine (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.