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

NCT06260371 | Completed DMC

• 1 other identifier: ORIGAMI
• Study Type: observational
• Target: 1,145
• Locations: 1 country
• Sites: 1

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.

Conditions

Mycoplasma Infections; Hospitalized Children

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Identify risk factors of serious infection

  1 year

• Identify predictive signs of serious infection

  1 year

• Type of complications

  1 year

• Patients outcome

  1 year

• healthcare used for infected children

  1 year

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

hospitalised children under 18 age, with Mycoplasma infection

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Association Clinique Thérapeutique Infantile du val de Marne: lead
• Groupe de Pathologies Infectieuses Pédiatriques (GPIP): collaborator

Study Sites (1)

ACTIV

Créteil, 94600, France

Location

Related Publications (1)

• 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.

  PMID: 41274297 RESULT

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

nasopharyngeal, oropharyngeal, lung, pleural puncture, pleural fluid, skin swab, cerebrospinal fluid, biopsy, etc... taken during routine care may be stored at hospital and analysed later. These data could be explored during end-of-study analysis.

MeSH Terms

Conditions

Mycoplasma Infections

Condition Hierarchy (Ancestors)

Mycoplasmatales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Corinne Levy

  Association Clinique Thérapeutique Infantile du val de Marne

  STUDY DIRECTOR

• Anais Chosidow

  Hôpital Intercommunal de Villeneuve-Saint-Georges

  PRINCIPAL INVESTIGATOR

• Emilie Pauquet

  Hôpital des Enfants, CHU de Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: September 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

FR (1)