NCT05981599

Brief Summary

An unusual increase in cases of invasive meningococcal infection between late 2022 and early 2023. These cases sometimes had atypical presentations (large numbers of bacteremias without meningitis). The distribution of serogroups was also unusual in our center (large number of serotype Y meningococcal IMD). This development comes after three years marked by the Corona-Virus-Disease-19 pandemic, which led to a profound change in the behaviors involved in the transmission of infectious diseases. Barrier measures have considerably reduced the population's exposure to meningococcus, and may have encouraged a reduction in mucosal immunity to this pathogen. The end of 2022 was also marked by intense viral circulation (syncitial respiratory virus-influenza-COVID), which may have favored invasive forms.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

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

June 30, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

July 20, 2023

Last Update Submit

August 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patient presenting with Invasive Meningococcal infection and its serogroup

    \- Evolution of the Number of case according to time and the evolution of serogroup There will be two study period. The number of Invasive Meningococcal infection and their serogroup will be counted in each period.

    Two period of 18month, one when facial mask were recommanded, and one after

Interventions

There is no intervention. Only retrieving clinical, biological and epidemiological data from patient files

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient from the West part of France

You may qualify if:

  • Clinical diagnosis of Invasive Meningococcal infection (defined by the isolation of Neisseria meningitis in a normaly steril site (CSL, blood, articulation, ..) by PCR or culture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poitiers University

Poitiers, Vienne, 86000, France

RECRUITING

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • France CAZENAVE ROBLOT, PhD

    SPILF

    STUDY DIRECTOR

Central Study Contacts

Romain Millot, Resident

CONTACT

France CAZENAVE ROBLOT, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 8, 2023

Study Start

June 30, 2023

Primary Completion

August 30, 2023

Study Completion

September 30, 2023

Last Updated

August 9, 2023

Record last verified: 2023-08

Locations