- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04594785
Evaluation of Post Infectious Inflammatory Reaction (PIIR) Concerning Children After Streptococcus Pneumoniae, Streptococcus Pyogenes and Neisseria Meningococcus Invasive Infection (RIPI)
October 26, 2020 updated by: University Hospital, Montpellier
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.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eric JEZIORSKI
- Phone Number: 33 04 67 33 57 98
- Email: e-jeziorski@chu-montpellier.fr
Study Locations
-
-
-
Montpellier, France, 34295
- Recruiting
- Uhmontpellier
-
Contact:
- Eric Jeziorski, MCU-PH
- Phone Number: 33 04 67 33 66 03
- Email: e-jeziorski@chu-montpellier.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pediatric population
Description
Inclusion criteria:
- Less than 18 years of age
- Fever associated with GAS, NM, or SP invasive infection
Exclusion criteria:
- age > 18 years
- Impossibility to obtain the consent of parents / legal representatives.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Describe the frequency PIIRs
Time Frame: 1 day
|
Describe the frequency PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characteristics PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection
Time Frame: 1 day
|
Describe the characteristics PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection
|
1 day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predictors of PIIRs
Time Frame: 1 day
|
Identified the predictors of PIIRs in order to find warning symptoms
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Eric JEZIORSKI, University Hospital, Montpellier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 30, 2021
Study Registration Dates
First Submitted
October 13, 2020
First Submitted That Met QC Criteria
October 13, 2020
First Posted (Actual)
October 20, 2020
Study Record Updates
Last Update Posted (Actual)
October 28, 2020
Last Update Submitted That Met QC Criteria
October 26, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Disease Attributes
- Central Nervous System Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Pneumonia, Bacterial
- Meningitis, Bacterial
- Central Nervous System Bacterial Infections
- Meningococcal Infections
- Neisseriaceae Infections
- Pneumococcal Infections
- Inflammation
- Infections
- Communicable Diseases
- Pneumonia
- Pneumonia, Pneumococcal
- Meningitis, Meningococcal
- Meningitis
Other Study ID Numbers
- RECHMPL20_0550
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
NC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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