Infective PericarditisPERICARDITENCT02828085
Improvement of the Etiological Diagnosis of the Pericarditis
A study testing Nasal swab in people with Infective Pericarditis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Pericardial syndrome includes pericardites acute pericardial effusion and cardiac tamponade, recurrent pericarditis squeezing chronic pericarditis. The etiologies are very numerous and can be classified as infectious, neoplastic, metabolic or systemic, toxic causes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Pericarditis
- What is being tested?
- Nasal swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 979 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2013to 26 Oct 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patient prescribed with a pericarditis kit for etiological diagnosis of a pericardial syndrome.
- Adult patient (= or > 18 years old)
- Patient who freely signed the informed consent form.
- Patient affiliated to a health insurance regime
Who cannot join
- Minor patient ( age <18 years)
- Pregnant, parturient or breastfeeding woman
- Adult patient incapable or unable to consent
- Patient deprived of liberty under judgment
- Person living in a health or social specialised structure
- Person in vital emergency situation
Trial locations and contacts
1 site in 1 country.
About this study
Pericardial syndrome includes pericardites acute pericardial effusion and cardiac tamponade, recurrent pericarditis squeezing chronic pericarditis. The etiologies are very numerous and can be classified as infectious, neoplastic, metabolic or systemic, toxic causes. Diagnosis is difficult, and 80% of etiologies remain classified idiopathic. In their laboratory to improve the diagnosis of this syndrome investigators have developed a strategy of systematic prescription of biological tests by kit. This prescription by 'kit' strategy proved its interest by comparison with an intuitive requirement of biological. In this study investigators want to improve the diagnostic causative of pericarditis by implementing a new diagnostic strategy. This new strategy includes (i) samples additional less invasive for the patient, the swab pharyngeal and nasal, (ii) the addition of at the outset of more effective diagnostic techniques: specific Polymerase Chain Reaction (PCR)
- Conditions
- Infective Pericarditis
- Being tested
- Nasal swab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal swabBiological
Nasal swab will be performed in addition to the routine diagnosis visit in order to determine the diagnosis of infective pericardite with a more specific technique: PCR
| Study group | Role | What they receive |
|---|---|---|
| Infective Pericarditis | Other | In patient prescribed with a pericardite kit for an etiological diagnosis of a pericardial syndrome, an additional nasal swab will be performed in order to perform a specific diagnosis with PCR technique. Receives: Biological: Nasal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of pericarditis whose etiological diagnosis has been established.
Measured: 1 day
Secondary outcomes (2)
Identification of the detected emerging pathogens among infectious causesof pericarditis
Measured: 1 day
Prevalence of the emerging pathogens: assessement of the percentage of emerging pathogens among the studied population
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 posted11 Jul 2016 (estimated)
- Study start7 Jul 2013
- Primary completion24 Jul 2019
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective PericarditisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 979 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828085
- Sponsor's protocol ID
- 2013-30
- Other IDs
- 2013-A00962-43
- Acronym
- PERICARDITE
- Status last verified
- Apr 2023
- First submitted
- 30 Jun 2016
- Last updated
- 21 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of the Etiological Diagnosis of the Pericarditis
- ClinicalTrials.gov ID
- NCT02828085
- Acronym / sponsor ID
- PERICARDITE / 2013-30
- Conditions
- Infective Pericarditis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 979 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 7 Jul 2013 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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.
Pericardial syndrome includes pericardites acute pericardial effusion and cardiac tamponade, recurrent pericarditis squeezing chronic pericarditis. The etiologies are very numerous and can be classified as infectious, neoplastic, metabolic or systemic, toxic causes. Diagnosis is difficult, and 80% of etiologies remain classified idiopathic. In their laboratory to improve the diagnosis of this syndrome investigators have developed a strategy of systematic prescription of biological tests by kit. This prescription by 'kit' strategy proved its interest by comparison with an intuitive requirement of biological. In this study investigators want to improve the diagnostic causative of pericarditis by implementing a new diagnostic strategy. This new strategy includes (i) samples additional less invasive for the patient, the swab pharyngeal and nasal, (ii) the addition of at the outset of more effective diagnostic techniques: specific Polymerase Chain Reaction (PCR)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infective Pericarditis | Other | Biological: Nasal swabIn patient prescribed with a pericardite kit for an etiological diagnosis of a pericardial syndrome, an additional nasal swab will be performed in order to perform a specific diagnosis with PCR technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient prescribed with a pericarditis kit for etiological diagnosis of a pericardial syndrome.
- Adult patient (= or > 18 years old)
- Patient who freely signed the informed consent form.
- Patient affiliated to a health insurance regime
Key exclusion criteria (6 listed)
- Minor patient ( age <18 years)
- Pregnant, parturient or breastfeeding woman
- Adult patient incapable or unable to consent
- Patient deprived of liberty under judgment
- Person living in a health or social specialised structure
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 |
|---|---|---|
| Nasal swabNasal swab will be performed in addition to the routine diagnosis visit in order to determine the diagnosis of infective pericardite with a more specific technique: PCR | Biological | Infective Pericarditis |
Primary outcome
Percentage of pericarditis whose etiological diagnosis has been established.
Time frame: 1 day
2 secondary outcomes
Identification of the detected emerging pathogens among infectious causesof pericarditis
Time frame: 1 day
Prevalence of the emerging pathogens: assessement of the percentage of emerging pathogens among the studied population
Time frame: 1 day
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 21 Apr 2023.
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?
A study testing Nasal swab in people with Infective Pericarditis, run by Assistance Publique Hopitaux De Marseille 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 4 inclusion and 6 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 21 Apr 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 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?
Percentage of pericarditis whose etiological diagnosis has been established. (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 21 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.