Mycoplasma InfectionsORIGAMINCT06260371
National Observatory of Mycoplasma Infections in Children Under 18 Ages in France
An observational study of Mycoplasma Infections and Hospitalized Children, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Mycoplasma Infections, Hospitalized Children
- How many people
- 1,145 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2023to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 17 years
- All sexes
- Child
Study population: hospitalised children under 18 age, with Mycoplasma infection
Who may be able to join
- Age <18 years (only hospitalized children)
- Documented mycoplasma infection (positive multiplex PCR and/or positive serology)
Who cannot join
- Refusal by one of the parents or by Child in understanding age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mycoplasma Infections, Hospitalized Children
- Medical subject headings
- Mycoplasma Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients hospitalized for mycoplasma infections
Proportion of hospitalized children due to mycoplasma infections
Measured: 1 year
medical characterisation of mycoplasma infections
Assessment of clinical, biological and microbiological characteristics of mycoplasma infections cases.
Measured: 1 year
Secondary outcomes (10)
Identify risk factors of serious infection
Describe what is responsible of serious infection.
Measured: 1 year
Identify predictive signs of serious infection
what are the warning signs of a serious infection?
Measured: 1 year
Type of complications
Describe any complications due to infection
Measured: 1 year
Patients outcome
Proportion of patients recovered
Measured: 1 year
healthcare used for infected children
Describe healthcare provided during hospitalisation of infected children in order to manage this type of infection
Measured: 1 year
treatment used during hospitalisation
type of treatment used during hospitalisation to manage the infection
Measured: 1 year
clinical description of infected children
clinical description of all cases of mycoplasma infections reported during the study
Measured: 1 year
Type of mycoplasma involved in infected children
characterisation of mycoplasma involved in infection (strain, molecular epidemiology and antibiotic resistance)
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Sep 2023
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mycoplasma InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe de Pathologies Infectieuses Pédiatriques (GPIP)
- Responsible party
- Sponsor
- Investigators
- Corinne Levy, Study director, Association Clinique Thérapeutique Infantile du val de MarneAnais Chosidow, Principal investigator, Hôpital Intercommunal de Villeneuve-Saint-GeorgesEmilie Pauquet, Principal investigator, Hôpital des Enfants, CHU de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260371
- Sponsor's protocol ID
- ORIGAMI
- Acronym
- ORIGAMI
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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. 2026 Apr;26(4):374-383. doi: 10.1016/S1473-3099(25)00598-5. Epub 2025 Nov 19.
PubMed 41274297
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Observatory of Mycoplasma Infections in Hospitalized Children Under 18 Ages in France
- ClinicalTrials.gov ID
- NCT06260371
- Acronym / sponsor ID
- ORIGAMI / ORIGAMI
- Conditions
- Mycoplasma Infections, Hospitalized Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,145 participants (actual)
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de MarneUniversity, hospital or other
- Collaborators
- Groupe de Pathologies Infectieuses Pédiatriques (GPIP)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- hospitalised children under 18 age, with Mycoplasma infection
Key inclusion criteria (2 listed)
- Age <18 years (only hospitalized children)
- Documented mycoplasma infection (positive multiplex PCR and/or positive serology)
Key exclusion criteria (1 listed)
- Refusal by one of the parents or by Child in understanding age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients hospitalized for mycoplasma infections
Time frame: 1 year
Proportion of hospitalized children due to mycoplasma infections
medical characterisation of mycoplasma infections
Time frame: 1 year
Assessment of clinical, biological and microbiological characteristics of mycoplasma infections cases.
10 secondary outcomes
Identify risk factors of serious infection
Time frame: 1 year
Identify predictive signs of serious infection
Time frame: 1 year
Type of complications
Time frame: 1 year
Patients outcome
Time frame: 1 year
healthcare used for infected children
Time frame: 1 year
treatment used during hospitalisation
Time frame: 1 year
clinical description of infected children
Time frame: 1 year
Type of mycoplasma involved in infected children
Time frame: 1 year
Assessment of Complementary Diagnostic Test Performance in Lung Disorders
Time frame: 1 year
Correlation between diagnostic test results in Infected Children
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Results publication: PubMed 41274297Chosidow 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. 2026 Apr;26(4):374-383. doi: 10.1016/S1473-3099(25)00598-5. Epub 2025 Nov 19.
- Post-COVID-19 resurgence of Mycoplasma pneumoniae infections in French children (ORIGAMI): a retrospective and prospective multicentre cohort studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Levy study director
Association Clinique Thérapeutique Infantile du val de Marne
Anais Chosidow principal investigator
Hôpital Intercommunal de Villeneuve-Saint-Georges
Emilie Pauquet principal investigator
Hôpital des Enfants, CHU de Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycoplasma Infections and Hospitalized Children, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients hospitalized for mycoplasma infections (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06260371, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.