Nosocomial PneumoniaNCT05928208
The Role of Point-of-care Polymerase Chain Reaction in Managing Nosocomial Pneumonia
An observational study of Nosocomial Pneumonia, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
The study compares a device that is used for the detection of bacteria and MDR pathogens from skin, soft tissue and nose with the gold-standard (microbiological lab). It is a novel use for this device because it has been used in samples from the lower-respiratory tract. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nosocomial Pneumonia
- How many people
- 60 participants
- Where
- 1 siteRomania
- Study dates
- 1 Feb 2017to 30 May 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with symptoms of nosocomial pneumonia
Who may be able to join
- patients that are admitted for at least 48 hours
- radiological findings typical for pneumonia
- signs of infection
Who cannot join
- patient or patient relatives doesn't accept to enter the study
Trial locations and contacts
1 site in 1 country.
About this study
The study compares a device that is used for the detection of bacteria and MDR pathogens from skin, soft tissue and nose with the gold-standard (microbiological lab). It is a novel use for this device because it has been used in samples from the lower-respiratory tract.
Read the detailed description
The purpose of this study is to find out if a POC-PCR device can be use in the diagnosis of hospital acquired pneumonia and ventilation-associated pneumonia.
- Conditions
- Nosocomial Pneumonia
- Being tested
- no intervention
- Keywords
- polymerase chain reaction
- 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.
no interventionDiagnostic test
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the sensibility and specificity of the device GeneXpert in diagnosis of pneumonia
Comparison between device and gold standard
Measured: 4 years
Utility of POC-PCR in managing pneumonia
Decision making in pneumonia management
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Feb 2017
- Primary completion30 May 2023
- Study completion30 May 2023
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.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balan Andrei Mihai, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Andrei Balan, MD, Principal investigator, Universitatea de Medicina si Farmacie "Iuliu Hatieganu" Cluj-Napoca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928208
- Sponsor's protocol ID
- 82/03.03.2017
- Status last verified
- Jun 2023
- First submitted
- 18 Jun 2017
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Point-of-care Polymerase Chain Reaction in Managing Nosocomial Pneumonia
- ClinicalTrials.gov ID
- NCT05928208
- Acronym / sponsor ID
- 82/03.03.2017
- Conditions
- Nosocomial Pneumonia
- Keywords
- polymerase chain reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 3 Jul 2023 (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.
The study compares a device that is used for the detection of bacteria and MDR pathogens from skin, soft tissue and nose with the gold-standard (microbiological lab). It is a novel use for this device because it has been used in samples from the lower-respiratory tract.
Detailed description
The purpose of this study is to find out if a POC-PCR device can be use in the diagnosis of hospital acquired pneumonia and ventilation-associated pneumonia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptoms of nosocomial pneumonia
Key inclusion criteria (3 listed)
- patients that are admitted for at least 48 hours
- radiological findings typical for pneumonia
- signs of infection
Key exclusion criteria (1 listed)
- patient or patient relatives doesn't accept to enter the study
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 |
|---|---|---|
| no interventionno intervention | Diagnostic test | – |
Primary outcome
To determine the sensibility and specificity of the device GeneXpert in diagnosis of pneumonia
Time frame: 4 years
Comparison between device and gold standard
Utility of POC-PCR in managing pneumonia
Time frame: 4 years
Decision making in pneumonia management
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 3 Jul 2023.
- 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.
Andrei Balan, MD principal investigator
Universitatea de Medicina si Farmacie "Iuliu Hatieganu" Cluj-Napoca
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 Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 3 inclusion and 1 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 3 Jul 2023. 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 Romania. 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?
To determine the sensibility and specificity of the device GeneXpert in diagnosis of pneumonia (time frame: 4 years). The study lists 2 primary outcomes in all. 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 3 Jul 2023.