Mycoplasma Pneumoniae PneumoniaNCT07333833
Development and Validation of an Early Prediction Model for Severe Mycoplasma Pneumoniae Pneumonia in Children
An observational study of Mycoplasma Pneumoniae Pneumonia, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Pneumonia is a major threat to the health of children. Mycoplasma pneumoniae infection is a core cause of pediatric pneumonia, and the incidence of severe mycoplasma pneumoniae pneumonia (SMPP) has increased in recent years. Read more about this study
- Who is it for?
- Ages 1 month to 14 years
- Conditions the study is for
- Mycoplasma Pneumoniae Pneumonia
- What is being tested?
- medical history taking, blood test, pulmonary ultrasound
- How many people
- 964 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Jun 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 month to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children hospitalized at Beijing Friendship Hospital between 2018-01-01 and 2024-06-01, diagnosed with MPP, and with a hospital stay > 3 days (aged 1 month to 14 years) were enrolled. According to disease severity, they were divided into the mild MPP (MPP group) and severe MPP (SMPP group).
Who may be able to join
- Age between 1 month to 14 years
- diagnosed with Mycoplasma pneumoniae pneumonia
- hospital stay ≥ 72 hours
Who cannot join
- pulmonary chronicles
- cardiovascular conditions
- inherited metabolic disorders
- immuno-deficiency disorders
- coinfection with pathogens other than Mycoplasma pneumoniae
Trial locations and contacts
1 site in 1 country.
About this study
Pneumonia is a major threat to the health of children. Mycoplasma pneumoniae infection is a core cause of pediatric pneumonia, and the incidence of severe mycoplasma pneumoniae pneumonia (SMPP) has increased in recent years. SMPP leads to a range of extrapulmonary symptoms, including myocardial and liver injury, which may be life-threatening. Therefore, there is an urgent need to establish an early warning model for SMPP to improve the prognosis of pediatric pneumonia. This observational study aims to establish a early prediction model of SMPP. Development cohorts are enrolled from Beijing Friendship Hospital between 2018-1-1 to 2024-5-31, and validation cohorts are enrolled between 2024-6-1 to 2025-6-30.
- Conditions
- Mycoplasma Pneumoniae Pneumonia
- Being tested
- medical history taking, blood test, pulmonary ultrasound
- Keywords
- severe mycoplasma pneumoniae pneumonia
- Medical subject headings
- Pneumonia, Mycoplasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical history taking, blood test, pulmonary ultrasoundOther
medical history taking, blood test, pulmonary ultrasound are used for MPP and SMPP diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Development | A primary cohort of eligible patients from the Beijing Friendship Hospital between 2018-1-1 and 2024-5-31 is used for model derivation. Receives: Other: medical history taking, blood test, pulmonary ultrasound | |
| Internal cross-validation | A cohort of consecutive patients from the Beijing Friendship Hospital between 2018-1-1 and 2024-5-31 is used for internal cross-validation. Receives: Other: medical history taking, blood test, pulmonary ultrasound | |
| External validation | A cohort of patients from the Beijing Friendship Hospital between 2024-6-1 and 2025-6-30 is used for internal cross-validation. Receives: Other: medical history taking, blood test, pulmonary ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC)
The AUC of prediction model for SMPP
Measured: through the hospitalization, an average of 7 days
Secondary outcomes (4)
Sensitivity
The sensitivity of prediction model for SMPP
Measured: through the hospitalization, an average of 7 days
Specificity
Specificity of prediction model for SMPP
Measured: through the hospitalization, an average of 7 days
Positive prediction value (PPV)
Positive prediction value (PPV) of prediction model for SMPP
Measured: through the hospitalization, an average of 7 days
Negative prediction value (NPV)
Negative prediction value (NPV) of prediction model for SMPP
Measured: through the hospitalization, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jan 2018
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycoplasma Pneumoniae PneumoniaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 964 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333833
- Sponsor's protocol ID
- V120250926
- Status last verified
- Jan 2018
- First submitted
- 22 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Early Prediction Model for Severe Mycoplasma Pneumoniae Pneumonia in Children
- ClinicalTrials.gov ID
- NCT07333833
- Acronym / sponsor ID
- V120250926
- Conditions
- Mycoplasma Pneumoniae Pneumonia
- Keywords
- severe mycoplasma pneumoniae pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 964 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 12 Jan 2026 (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.
Pneumonia is a major threat to the health of children. Mycoplasma pneumoniae infection is a core cause of pediatric pneumonia, and the incidence of severe mycoplasma pneumoniae pneumonia (SMPP) has increased in recent years. SMPP leads to a range of extrapulmonary symptoms, including myocardial and liver injury, which may be life-threatening. Therefore, there is an urgent need to establish an early warning model for SMPP to improve the prognosis of pediatric pneumonia. This observational study aims to establish a early prediction model of SMPP. Development cohorts are enrolled from Beijing Friendship Hospital between 2018-1-1 to 2024-5-31, and validation cohorts are enrolled between 2024-6-1 to 2025-6-30.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Development | – | Other: medical history taking, blood test, pulmonary ultrasoundA primary cohort of eligible patients from the Beijing Friendship Hospital between 2018-1-1 and 2024-5-31 is used for model derivation. |
| Internal cross-validation | – | Other: medical history taking, blood test, pulmonary ultrasoundA cohort of consecutive patients from the Beijing Friendship Hospital between 2018-1-1 and 2024-5-31 is used for internal cross-validation. |
| External validation | – | Other: medical history taking, blood test, pulmonary ultrasoundA cohort of patients from the Beijing Friendship Hospital between 2024-6-1 and 2025-6-30 is used for internal cross-validation. |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children hospitalized at Beijing Friendship Hospital between 2018-01-01 and 2024-06-01, diagnosed with MPP, and with a hospital stay > 3 days (aged 1 month to 14 years) were enrolled. According to disease severity, they were divided into the mild MPP (MPP group) and severe MPP (SMPP group).
Key inclusion criteria (3 listed)
- Age between 1 month to 14 years
- diagnosed with Mycoplasma pneumoniae pneumonia
- hospital stay ≥ 72 hours
Key exclusion criteria (5 listed)
- pulmonary chronicles
- cardiovascular conditions
- inherited metabolic disorders
- immuno-deficiency disorders
- coinfection with pathogens other than Mycoplasma pneumoniae
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical history taking, blood test, pulmonary ultrasoundmedical history taking, blood test, pulmonary ultrasound are used for MPP and SMPP diagnosis | Other | Development, External validation, Internal cross-validation |
Primary outcome
Area under the curve (AUC)
Time frame: through the hospitalization, an average of 7 days
The AUC of prediction model for SMPP
4 secondary outcomes
Sensitivity
Time frame: through the hospitalization, an average of 7 days
Specificity
Time frame: through the hospitalization, an average of 7 days
Positive prediction value (PPV)
Time frame: through the hospitalization, an average of 7 days
Negative prediction value (NPV)
Time frame: through the hospitalization, an average of 7 days
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 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Mycoplasma Pneumoniae Pneumonia
Not yet recruitingObservational study
Comparative Study of Adherence to Antibiotic Therapy Among Pediatric Patients: Hospital Emergency Department vs. Primary Care Center
Tonsillitis Acute, Pneumonia - Bacterial
Not yet recruitingObservational study
Community-acquired Pneumonia Due to Chlamydia Pneumoniae
Community-Acquired Pneumonia
Recruiting
A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study
Community Acquired Pneumonia in Children, Mycoplasma Pneumoniae
Active, not recruitingObservational study
CARE-ID: Dynamics of Respiratory Infections in Children and Transmission in Households and Schools
SARS CoV 2 Infection, RSV Infection
Active, not recruitingObservational study
Study of the Characteristics of Acute Mycoplasma Resuscitation: ECRAN-PLASMA Study
Pneumonia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pneumoniae Pneumonia, run by Beijing Friendship Hospital at 1 site in China.
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 3 inclusion and 5 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 12 Jan 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 China. 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?
Area under the curve (AUC) (time frame: through the hospitalization, an average of 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2026.