Streptococcus PneumoniaRIPINCT04594785
Evaluation of Post Infectious Inflammatory Reaction (PIIR) Concerning Children After Streptococcus Pneumoniae, Streptococcus Pyogenes and Neisseria Meningococcus Invasive Infection
An observational study of Streptococcus Pneumonia and Streptococcus Pyogenes Infection, run by University Hospital, Montpellier at 1 site in France.
Trial summary
As Covid 19 manifestations that have been recently described, inflammatory manifestation have major impact in infectious disease lesions. Some of them are delayed and provide Post infectious inflammatory reaction (PIIR), they are challenging for diagnosis and for management. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Streptococcus Pneumonia, Streptococcus Pyogenes Infection, Neisseria Meningitides Meningitis
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 30 Dec 2021
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric population
Who may be able to join
- Less than 18 years of age
- Fever associated with GAS, NM, or SP invasive infection
Who cannot join
- age > 18 years
- Impossibility to obtain the consent of parents / legal representatives.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Eric Jeziorski, MCU-PH, 04 67 33 66 03 ext. 33, e-jeziorski@chu-montpellier.fr
About this study
Official title: Evaluation of Post Infectious Inflammatory Reaction (PIIR) in a Retrospective Study Concerning Children After Streptococcus Pneumoniae, Streptococcus Pyogenes and Neisseria Meningococcus Invasive Infection
As Covid 19 manifestations that have been recently described, inflammatory manifestation have major impact in infectious disease lesions. Some of them are delayed and provide Post infectious inflammatory reaction (PIIR), they are challenging for diagnosis and for management. Clinician have to avoid unnecessary antibiotic thearapy and in if necessary have to give immunosuppressive therapy. Except for rheumatic disease for group A streptococcus (GAS) infections there are not stanrdized diagnostic criteria and therapeutic protocol, and PIIR have probably a suboptimal management. In this context the investigators aim to explore PIIR in the 3 most frequent bacterial invasive infection in France, by a retrospective monocentric study. The investigators include all children betwwen 2012 and 2018 hospitalized for infections by Streptococcus pneumoniae (SP), Neisseria meningitidis (NM), and GAS invasive infections.
- Conditions
- Streptococcus Pneumonia, Streptococcus Pyogenes Infection, Neisseria Meningitides Meningitis
- Keywords
- post-infectious inflammatory reactions, Neisseria Meningitis
- Medical subject headings
- Pneumonia, Streptococcal Infections, Meningitis, Meningococcal
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the frequency PIIRs
Describe the frequency PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection
Measured: 1 day
Secondary outcomes (1)
Characteristics PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection
Describe the characteristics PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection
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 posted20 Oct 2020
- Study start1 Oct 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus PneumoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric JEZIORSKI, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594785
- Sponsor's protocol ID
- RECHMPL20_0550
- Acronym
- RIPI
- Status last verified
- Oct 2020
- First submitted
- 13 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post Infectious Inflammatory Reaction (PIIR) in a Retrospective Study Concerning Children After Streptococcus Pneumoniae, Streptococcus Pyogenes and Neisseria Meningococcus Invasive Infection
- ClinicalTrials.gov ID
- NCT04594785
- Acronym / sponsor ID
- RIPI / RECHMPL20_0550
- Conditions
- Streptococcus Pneumonia, Streptococcus Pyogenes Infection, Neisseria Meningitides Meningitis
- Keywords
- post-infectious inflammatory reactions, Neisseria Meningitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 20 Oct 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.
As Covid 19 manifestations that have been recently described, inflammatory manifestation have major impact in infectious disease lesions. Some of them are delayed and provide Post infectious inflammatory reaction (PIIR), they are challenging for diagnosis and for management. Clinician have to avoid unnecessary antibiotic thearapy and in if necessary have to give immunosuppressive therapy. Except for rheumatic disease for group A streptococcus (GAS) infections there are not stanrdized diagnostic criteria and therapeutic protocol, and PIIR have probably a suboptimal management. In this context the investigators aim to explore PIIR in the 3 most frequent bacterial invasive infection in France, by a retrospective monocentric study. The investigators include all children betwwen 2012 and 2018 hospitalized for infections by Streptococcus pneumoniae (SP), Neisseria meningitidis (NM), and GAS invasive infections.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric population
Key inclusion criteria (2 listed)
- Less than 18 years of age
- Fever associated with GAS, NM, or SP invasive infection
Key exclusion criteria (2 listed)
- age > 18 years
- Impossibility to obtain the consent of parents / legal representatives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe the frequency PIIRs
Time frame: 1 day
Describe the frequency PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection
1 secondary outcome
Characteristics PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Eric JEZIORSKI study director
University Hospital, Montpellier
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 Streptococcus Pneumonia and Streptococcus Pyogenes Infection, run by University Hospital, Montpellier 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric JEZIORSKI (04 67 33 57 98 ext. 33, e-jeziorski@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the frequency PIIRs (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 28 Oct 2020.