Meningococcal InfectionsSAMIRANCT02041663
Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis
A study testing BNP in people with Meningococcal Infections and Septic Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Use of brain natriuretic peptide to evaluate the cardiac function in the course of meningococcal septic shock or severe sepsis. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Meningococcal Infections, Septic Shock, Severe Sepsis
- What is being tested?
- BNP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2012to 11 Jul 2018
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children
- 6 months to 18 years aged
- without previous cardiac pathology
- hospitalized in the participating pediatric intensive care units for serious sepsis with extensive purpura
Who cannot join
- Heart malformative disorder with right-left shunt
- Pre-existent known cardiac insufficiency whatever is the origin
- Concomitant participation in another trial
- Patient in period of exclusion from another trial
- Not membership in a national insurance scheme
Trial locations and contacts
1 site in 1 country.
About this study
Use of brain natriuretic peptide to evaluate the cardiac function in the course of meningococcal septic shock or severe sepsis.
Read the detailed description
OBJECTIVES: determining sensibility and specificity of BNP blood level to detect myocardial dysfunction in septic shock or severe sepsis due to Neisseria meningitidis in children.
METHODS: Prospective multicentric clinical trial including 7 French pediatric intensive care units. Serial cardiac ultra sounds and blood sampling will be done for patients hospitalized for purpura fulminans beginning at the time of admission in pediatric intensive care. Any child from 6 months to 18 years without preexisting cardiac disease and presenting with purpura fulminans will be enrolled after obtaining consent of both parents. From adult's studies on septic shock and BNP, a total number of 30 patients was calculated to be necessary to prove the interest of BNP in this indication.
- Conditions
- Meningococcal Infections, Septic Shock, Severe Sepsis
- Being tested
- BNP
- Keywords
- brain natriuretic peptide, cardiac function, meningococcal infections, septic shock, severe sepsis
- Medical subject headings
- Meningococcal Infections, Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNPBiological
Repeated brain natriuretic peptide dosages and cardiac echographies up to day 5
| Study group | Role | What they receive |
|---|---|---|
| Population | Experimental | Repeated brain natriuretic peptide dosages and cardiac echographies up to day 5 Receives: Biological: BNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeated brain natriuretic peptide (BNP) blood level
Measured: Up to day 5
Secondary outcomes (5)
Repeated cardiac echography
Measured: Up to day 5
PRISM II gravity score
Measured: Up to day 5
Organ failure PELOD score
Measured: Up to day 5
Troponin rate
Measured: Up to day 5
mortality and morbidity (aftereffects)
Measured: Day 28 and hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study start5 Mar 2012
- Primary completion11 Jul 2018
- Study completion11 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal InfectionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Bergougnoux, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041663
- Sponsor's protocol ID
- AOR 10106
- Acronym
- SAMIRA
- Status last verified
- Aug 2023
- First submitted
- 20 Jan 2014
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis
- ClinicalTrials.gov ID
- NCT02041663
- Acronym / sponsor ID
- SAMIRA / AOR 10106
- Conditions
- Meningococcal Infections, Septic Shock, Severe Sepsis
- Keywords
- brain natriuretic peptide, cardiac function, meningococcal infections, septic shock, severe sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 5 Mar 2012 (actual)
- Primary completion
- 11 Jul 2018 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 22 Jan 2014 (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.
Use of brain natriuretic peptide to evaluate the cardiac function in the course of meningococcal septic shock or severe sepsis.
Detailed description
OBJECTIVES: determining sensibility and specificity of BNP blood level to detect myocardial dysfunction in septic shock or severe sepsis due to Neisseria meningitidis in children.
METHODS: Prospective multicentric clinical trial including 7 French pediatric intensive care units. Serial cardiac ultra sounds and blood sampling will be done for patients hospitalized for purpura fulminans beginning at the time of admission in pediatric intensive care. Any child from 6 months to 18 years without preexisting cardiac disease and presenting with purpura fulminans will be enrolled after obtaining consent of both parents. From adult's studies on septic shock and BNP, a total number of 30 patients was calculated to be necessary to prove the interest of BNP in this indication.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population | Experimental | Biological: BNPRepeated brain natriuretic peptide dosages and cardiac echographies up to day 5 |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children
- 6 months to 18 years aged
- without previous cardiac pathology
- hospitalized in the participating pediatric intensive care units for serious sepsis with extensive purpura
Key exclusion criteria (5 listed)
- Heart malformative disorder with right-left shunt
- Pre-existent known cardiac insufficiency whatever is the origin
- Concomitant participation in another trial
- Patient in period of exclusion from another trial
- Not membership in a national insurance scheme
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 |
|---|---|---|
| BNPRepeated brain natriuretic peptide dosages and cardiac echographies up to day 5 | Biological | Population |
Primary outcome
Repeated brain natriuretic peptide (BNP) blood level
Time frame: Up to day 5
5 secondary outcomes
Repeated cardiac echography
Time frame: Up to day 5
PRISM II gravity score
Time frame: Up to day 5
Organ failure PELOD score
Time frame: Up to day 5
Troponin rate
Time frame: Up to day 5
mortality and morbidity (aftereffects)
Time frame: Day 28 and hospital discharge
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 28 Aug 2023.
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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.
Jean Bergougnoux, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BNP in people with Meningococcal Infections and Septic Shock, run by Assistance Publique - Hôpitaux de Paris 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 5 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 28 Aug 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?
Repeated brain natriuretic peptide (BNP) blood level (time frame: Up to day 5). 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 28 Aug 2023.