NCT04594785

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

October 13, 2020

Last Update Submit

October 26, 2020

Conditions

Keywords

post-infectious inflammatory reactionsNeisseria Meningitis

Outcome Measures

Primary Outcomes (1)

  • Describe the frequency PIIRs

    Describe the frequency PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection

    1 day

Secondary Outcomes (1)

  • Characteristics PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection

    1 day

Other Outcomes (1)

  • Predictors of PIIRs

    1 day

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric population

You may qualify if:

  • Less than 18 years of age
  • Fever associated with GAS, NM, or SP invasive infection

You may not qualify if:

  • age \> 18 years
  • Impossibility to obtain the consent of parents / legal representatives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

PneumoniaStreptococcal InfectionsMeningitis, Meningococcal

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesMeningitis, BacterialCentral Nervous System Bacterial InfectionsMeningococcal InfectionsNeisseriaceae InfectionsGram-Negative Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Study Officials

  • Eric JEZIORSKI

    University Hospital, Montpellier

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 20, 2020

Study Start

October 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 30, 2021

Last Updated

October 28, 2020

Record last verified: 2020-10

Locations