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

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

Study Locations

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.

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

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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