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Completed

NCT Number: NCT06260371

National Observatory of Mycoplasma Infections in 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.

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Key information

Conditions

Mycoplasma Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Hospitalized Children Infections Mycoplasmatales Infections

Age range

1 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ACTIV

Créteil, 94600, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of patients hospitalized for mycoplasma infections

    Time frame: 1 year

    Proportion of hospitalized children due to mycoplasma infections

  2. medical characterisation of mycoplasma infections

    Time frame: 1 year

    Assessment of clinical, biological and microbiological characteristics of mycoplasma infections cases.

Secondary outcomes

  1. Identify risk factors of serious infection

    Time frame: 1 year

    Describe what is responsible of serious infection.

  2. Identify predictive signs of serious infection

    Time frame: 1 year

    what are the warning signs of a serious infection?

  3. Type of complications

    Time frame: 1 year

    Describe any complications due to infection

  4. Patients outcome

    Time frame: 1 year

    Proportion of patients recovered

  5. healthcare used for infected children

    Time frame: 1 year

    Describe healthcare provided during hospitalisation of infected children in order to manage this type of infection

  6. treatment used during hospitalisation

    Time frame: 1 year

    type of treatment used during hospitalisation to manage the infection

  7. clinical description of infected children

    Time frame: 1 year

    clinical description of all cases of mycoplasma infections reported during the study

  8. Type of mycoplasma involved in infected children

    Time frame: 1 year

    characterisation of mycoplasma involved in infection (strain, molecular epidemiology and antibiotic resistance)

  9. Assessment of Complementary Diagnostic Test Performance in Lung Disorders

    Time frame: 1 year

    To evaluate the performance of complementary diagnostic tests in children with lung disorders, including sensitivity, specificity, and agreement with standard diagnostic methods.

  10. Correlation between diagnostic test results in Infected Children

    Time frame: 1 year

    To evaluate the relationship between the results of various diagnostic tests in children with infection, aiming to identify patterns or predictors of disease severity.

Sponsors and collaborators

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Other

Collaborators

  • Groupe de Pathologies Infectieuses Pédiatriques (GPIP)

Registry information

Official study title

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

Acronym: ORIGAMI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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