Development and Validation of an Early Prediction Model for Severe Mycoplasma Pneumoniae Pneumonia in Children

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07333833

Enrollment

964

Registered

2026-01-12

Start date

2018-01-01

Completion date

2025-06-30

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycoplasma Pneumoniae Pneumonia

Keywords

severe mycoplasma pneumoniae pneumonia

Brief 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. 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.

Interventions

OTHERmedical history taking, blood test, pulmonary ultrasound

medical history taking, blood test, pulmonary ultrasound are used for MPP and SMPP diagnosis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Months to 14 Years

Healthy volunteers

Inclusion criteria

* Age between 1 month to 14 years * diagnosed with Mycoplasma pneumoniae pneumonia * hospital stay ≥ 72 hours

Exclusion criteria

* pulmonary chronicles * cardiovascular conditions * inherited metabolic disorders * immuno-deficiency disorders * coinfection with pathogens other than Mycoplasma pneumoniae

Design outcomes

Primary

Measure	Time frame	Description
Area under the curve (AUC)	through the hospitalization, an average of 7 days	The AUC of prediction model for SMPP

Secondary

Measure	Time frame	Description
Sensitivity	through the hospitalization, an average of 7 days	The sensitivity of prediction model for SMPP
Specificity	through the hospitalization, an average of 7 days	Specificity of prediction model for SMPP
Positive prediction value (PPV)	through the hospitalization, an average of 7 days	Positive prediction value (PPV) of prediction model for SMPP
Negative prediction value (NPV)	through the hospitalization, an average of 7 days	Negative prediction value (NPV) of prediction model for SMPP

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026