National Observatory of Mycoplasma Infections in Children Under 18 Ages in France

Recruiting

• Conditions: Hospitalized Children; Mycoplasma Infections

• Registration Number: NCT06260371
• Lead Sponsor: Association Clinique Thérapeutique Infantile du val de Marne

Brief Summary

This study was set up because of an unusual increase in the number of cases of mycoplasma infections in France between June and November 2023.

Clinical data from children with mycoplasma infections will be collected to characterise this infection and facilitate hospital management.

Detailed Description

In this study, the number of cases will be collected. In addition, we will determine the clinical, biological and microbiological characteristics of these cases.

These following data will be collected: signs or symptoms associated with this infection, clinical complications, biological and microbiological tests done during hospitalisation, treatment used during hospitalization, results of thoracic x-ray and lung ultrasound.

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2024-01
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Study First Posted: 2024-02-15
• Last Update Posted: 2024-02-15
• Primary Completion: 2030-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Age <18 years (only hospitalized children)
• Documented mycoplasma infection (positive multiplex PCR and/or positive serology)

Exclusion Criteria

• Refusal by one of the parents or by Child in understanding age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients hospitalized for mycoplasma infections	1 year	Proportion of hospitalized children due to mycoplasma infections
medical characterisation of mycoplasma infections	1 year	Assessment of clinical, biological and microbiological characteristics of mycoplasma infections cases.

Secondary Outcome Measures

Name	Time	Method
Identify predictive signs of serious infection	1 year	what are the warning signs of a serious infection?
Patients outcome	1 year	Proportion of patients recovered
healthcare used for infected children	1 year	Describe healthcare provided during hospitalisation of infected children in order to manage this type of infection
clinical description of infected children	1 year	clinical description of all cases of mycoplasma infections reported during the study
Type of mycoplasma involved in infected children	1 year	characterisation of mycoplasma involved in infection (strain, molecular epidemiology and antibiotic resistance)
Identify risk factors of serious infection	1 year	Describe what is responsible of serious infection.
performance of complementary diagnostic tests for lung disorders	1 year	for lung disorders, assessment of performance of complementary diagnostic tests (chest X-ray, lung ultrasound, C reactive protein (CRP), multiplex polymerase chain reaction (PCR), etc).
Type of complications	1 year	Describe any complications due to infection
treatment used during hospitalisation	1 year	type of treatment used during hospitalisation to manage the infection
compare medical data collected during hospitalisation	1 year	Assessment of the correlation between clinical, radiological and biological data of infected children

Trial Locations

Locations (1)

ACTIV; 🇫🇷 Créteil, France