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

NCT07333833 | Completed

• 1 other identifier: V120250926
• Study Type: observational
• Target: 964
• Locations: 1 country
• Sites: 1

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.

Conditions

Mycoplasma Pneumoniae Pneumonia

Keywords

severe mycoplasma pneumoniae pneumonia

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC)

  The AUC of prediction model for SMPP

  through the hospitalization, an average of 7 days

Secondary Outcomes (4)

• Sensitivity

  through the hospitalization, an average of 7 days

• Specificity

  through the hospitalization, an average of 7 days

• Positive prediction value (PPV)

  through the hospitalization, an average of 7 days

• Negative prediction value (NPV)

  through the hospitalization, an average of 7 days

Study Arms (3)

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.

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.

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.

Other: medical history taking, blood test, pulmonary ultrasound

Interventions

medical history taking, blood test, pulmonary ultrasound OTHER

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

Development; External validation; Internal cross-validation

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Pneumonia, Mycoplasma

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Mycoplasma Infections; Mycoplasmatales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2018
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 12, 2026

Record last verified: 2018-01

Locations

CN (1)