National Observatory of Mycoplasma Infections in Children Under 18 Ages in France (ORIGAMI)

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

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.

Study Overview

• Status: Completed
• Conditions: Mycoplasma Infections; Hospitalized Children

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 Type: Observational
• Enrollment (Actual): 1145

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94600
    • ACTIV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

hospitalised children under 18 age, with Mycoplasma infection

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify risk factors of serious infection	Describe what is responsible of serious infection.	1 year
Identify predictive signs of serious infection	what are the warning signs of a serious infection?	1 year
Type of complications	Describe any complications due to infection	1 year
Patients outcome	Proportion of patients recovered	1 year
healthcare used for infected children	Describe healthcare provided during hospitalisation of infected children in order to manage this type of infection	1 year
treatment used during hospitalisation	type of treatment used during hospitalisation to manage the infection	1 year
clinical description of infected children	clinical description of all cases of mycoplasma infections reported during the study	1 year
Type of mycoplasma involved in infected children	characterisation of mycoplasma involved in infection (strain, molecular epidemiology and antibiotic resistance)	1 year
Assessment of Complementary Diagnostic Test Performance in Lung Disorders	To evaluate the performance of complementary diagnostic tests in children with lung disorders, including sensitivity, specificity, and agreement with standard diagnostic methods.	1 year
Correlation between diagnostic test results in Infected Children	To evaluate the relationship between the results of various diagnostic tests in children with infection, aiming to identify patterns or predictors of disease severity.	1 year

Collaborators and Investigators

• Sponsor: Association Clinique Thérapeutique Infantile du val de Marne
• Collaborators: Groupe de Pathologies Infectieuses Pédiatriques (GPIP)
• Investigators: Study Director: Corinne Levy, Association Clinique Thérapeutique Infantile du val de Marne; Principal Investigator: Anais Chosidow, Hôpital Intercommunal de Villeneuve-Saint-Georges; Principal Investigator: Emilie Pauquet, Hôpital des Enfants, CHU de Bordeaux

Publications and helpful links

General Publications

• Chosidow A, Maakaroun-Vermesse Z, Ok V, Delecroix C, Le Roux P, Dommergues MA, de Larminat J, Jeziorski E, Ronjat P, Jaume L, Welfringer-Morin A, Bebear C, Gits-Muselli M, Viriot D, Roux CJ, Bechet S, Romain AS, Lorrot M, Cohen R, Levy C, Cohen JF; ORIGAMI Study Group. Post-COVID-19 resurgence of Mycoplasma pneumoniae infections in French children (ORIGAMI): a retrospective and prospective multicentre cohort study. Lancet Infect Dis. 2025 Nov 19:S1473-3099(25)00598-5. doi: 10.1016/S1473-3099(25)00598-5. Online ahead of print.

Helpful Links

• Post-COVID-19 resurgence of Mycoplasma pneumoniae infections in French children (ORIGAMI): a retrospective and prospective multicentre cohort study

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Mycoplasmatales Infections; Mycoplasma Infections
• Other Study ID Numbers: ORIGAMI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No