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

Hospitalized Children Clinical Trial

— ORIGAMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06260371
• Other study ID #: ORIGAMI
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: September 1, 2030

Study information

• Verified date: January 2024
• Source: Association Clinique Thérapeutique Infantile du val de Marne
• Contact: Corinne Levy, MD
• Phone: 1 48 85 04 04
• Email: corinne.levy[@]activ-france.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: September 1, 2030
• Est. primary completion date: September 1, 2030
• Gender: All
• Age group: 1 Day to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hospitalized Children
• Infections
• Mycoplasma Infections
• Pleuropneumonia

Locations

Country	Name	City	State
France	ACTIV	Créteil

Sponsors (2)

Lead Sponsor	Collaborator
Association Clinique Thérapeutique Infantile du val de Marne	GPIP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients hospitalized for mycoplasma infections	Proportion of hospitalized children due to mycoplasma infections	1 year
Primary	medical characterisation of mycoplasma infections	Assessment of clinical, biological and microbiological characteristics of mycoplasma infections cases.	1 year
Secondary	Identify risk factors of serious infection	Describe what is responsible of serious infection.	1 year
Secondary	Identify predictive signs of serious infection	what are the warning signs of a serious infection?	1 year
Secondary	Type of complications	Describe any complications due to infection	1 year
Secondary	Patients outcome	Proportion of patients recovered	1 year
Secondary	healthcare used for infected children	Describe healthcare provided during hospitalisation of infected children in order to manage this type of infection	1 year
Secondary	treatment used during hospitalisation	type of treatment used during hospitalisation to manage the infection	1 year
Secondary	clinical description of infected children	clinical description of all cases of mycoplasma infections reported during the study	1 year
Secondary	Type of mycoplasma involved in infected children	characterisation of mycoplasma involved in infection (strain, molecular epidemiology and antibiotic resistance)	1 year
Secondary	performance of complementary diagnostic tests for lung disorders	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).	1 year
Secondary	compare medical data collected during hospitalisation	Assessment of the correlation between clinical, radiological and biological data of infected children	1 year