Viral PneumoniaVirCoV+NCT06349707
Multiplex PCR for Severe Respiratory Infections During the COVID-19 Pandemic
An observational study of Viral Pneumonia, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The hypothesis was that a retrospective investigation of the molecular virological tests in a University hospital could be informative, with the aim to identify non-COVID-19 respiratory viruses during the circulation of SARS-CoV-2, according to systematic population data for public health knowledge. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Viral Pneumonia
- What is being tested?
- other: Observational
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2024to 1 Jun 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 18 Intensive Care Unit (ICU)-patients, from the whole population of patients who were hospitalized for respiratory infections from early 2021 to mid-2022 in Nancy University hospital, France: * from the results of the multiplex FilmArrays PCR tests carried out during the 18 months of the study; * for the ICU files, 18 patients positive for virus by the FilmArray Pneumonia test: ICU patients (or representatives) informed of the data collection that can be used for research (ICCA db)
Who may be able to join
- For adult patients, or minors 'via' parents, able to give consent - 18 intensive care patients
Who cannot join
- Non-inclusion in case of refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relevance of the Multiplex PCR Approach for Severe Respiratory Infections of Patients Hospitalized - Including an Intensive Care Unit, During the COVID-19 Pandemic
The hypothesis was that a retrospective investigation of the molecular virological tests in a University hospital could be informative, with the aim to identify non-COVID-19 respiratory viruses during the circulation of SARS-CoV-2, according to systematic population data for public health knowledge.
Read the detailed description
The hypothesis was that a retrospective investigation of the molecular virological tests in a University hospital could be informative, with the aim to identify non-COVID-19 respiratory viruses during the circulation of SARS-CoV-2, according to systematic population data for public health knowledge:
- the main goal was to perform a retrospective investigation of the molecular virological tests in a University hospital, in order to identify non-COVID-19 respiratory viruses from the beginning of 2021 to mid-2022 during the circulation of SARS-CoV-2, for public health knowledge;
- the secondary aim was to retrospectively analyze, for a small subgroup of patients from an intensive care unit, the files of patients with positive molecular virological tests for non-COVID-19 respiratory viruses from the beginning of 2021 to mid-2022, reporting the following standard-of-care data: (i) the identification of the viruses, (ii) bioclinical features, (iii) medical impact of virological results in real life.
- Conditions
- Viral Pneumonia
- Being tested
- other: Observational
- Keywords
- respiratory virus
- Medical subject headings
- Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
other: ObservationalOther
For 18 ICU patients, retrospective collection of routine bioclinical database (ICCA db)
| Study group | Role | What they receive |
|---|---|---|
| 18 ICU-patients group | 18 ICU (Intensive Care Unit)-patients group, from the whole population of patients (1,614) who were hospitalized for respiratory infections from early 2021 to mid-2022 in Nancy University hospital, France. Receives: Other: other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of positive viral PCR assays (not COVID-19) from hospitalizations for respiratory infections.
Number of patients with positive virological molecular tests (multiplex respiratory panels) from the beginning of 2021 to mid-2022, with the nature of the viruses detected and the chronology of occurrence of positive tests.
Measured: 18 months, retrospectively
Secondary outcomes (1)
Real-life features of patients in Intensive care (from the whole population - Outcome 1) with positive viral PCR during infectious pneumonia.
For the group of patients in Intensive Care:
- (i) number of positive molecular virological tests detecting respiratory viruses by FilmArray Pneumonia test
- (ii) associated bioclinical data
- (iii) medical impact of virological results in real life - progression of the infection and duration of thehospitalization.
Measured: 18 months, retrospectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Apr 2024
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral PneumoniaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349707
- Sponsor's protocol ID
- 2023PI112
- Acronym
- VirCoV+
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of the Multiplex PCR Approach for Severe Respiratory Infections of Patients Hospitalized - Including an Intensive Care Unit, During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT06349707
- Acronym / sponsor ID
- VirCoV+ / 2023PI112
- Conditions
- Viral Pneumonia
- Keywords
- respiratory virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 5 Apr 2024 (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 hypothesis was that a retrospective investigation of the molecular virological tests in a University hospital could be informative, with the aim to identify non-COVID-19 respiratory viruses during the circulation of SARS-CoV-2, according to systematic population data for public health knowledge.
Detailed description
The hypothesis was that a retrospective investigation of the molecular virological tests in a University hospital could be informative, with the aim to identify non-COVID-19 respiratory viruses during the circulation of SARS-CoV-2, according to systematic population data for public health knowledge:
- the main goal was to perform a retrospective investigation of the molecular virological tests in a University hospital, in order to identify non-COVID-19 respiratory viruses from the beginning of 2021 to mid-2022 during the circulation of SARS-CoV-2, for public health knowledge;
- the secondary aim was to retrospectively analyze, for a small subgroup of patients from an intensive care unit, the files of patients with positive molecular virological tests for non-COVID-19 respiratory viruses from the beginning of 2021 to mid-2022, reporting the following standard-of-care data: (i) the identification of the viruses, (ii) bioclinical features, (iii) medical impact of virological results in real life.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18 ICU-patients group | – | Other: other: Observational18 ICU (Intensive Care Unit)-patients group, from the whole population of patients (1,614) who were hospitalized for respiratory infections from early 2021 to mid-2022 in Nancy University hospital, France. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 18 Intensive Care Unit (ICU)-patients, from the whole population of patients who were hospitalized for respiratory infections from early 2021 to mid-2022 in Nancy University hospital, France: * from the results of the multiplex FilmArrays PCR tests carried out during the 18 months of the study; * for the ICU files, 18 patients positive for virus by the FilmArray Pneumonia test: ICU patients (or representatives) informed of the data collection that can be used for research (ICCA db)
Key inclusion criteria (1 listed)
- For adult patients, or minors 'via' parents, able to give consent - 18 intensive care patients
Key exclusion criteria (1 listed)
- Non-inclusion in case of refusal
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 |
|---|---|---|
| other: ObservationalFor 18 ICU patients, retrospective collection of routine bioclinical database (ICCA db) | Other | 18 ICU-patients group |
Primary outcome
Occurrence of positive viral PCR assays (not COVID-19) from hospitalizations for respiratory infections.
Time frame: 18 months, retrospectively
Number of patients with positive virological molecular tests (multiplex respiratory panels) from the beginning of 2021 to mid-2022, with the nature of the viruses detected and the chronology of occurrence of positive tests.
1 secondary outcome
Real-life features of patients in Intensive care (from the whole population - Outcome 1) with positive viral PCR during infectious pneumonia.
Time frame: 18 months, retrospectively
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 18 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Viral Pneumonia, run by Central Hospital, Nancy, France at 1 site in France.
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 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 18 Feb 2025. 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 France. 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?
Occurrence of positive viral PCR assays (not COVID-19) from hospitalizations for respiratory infections. (time frame: 18 months, retrospectively). 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 18 Feb 2025.