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Completed

NCT Number: NCT07333833

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

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.

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Key information

Conditions

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

Age range

1 month–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

medical history taking, blood test, pulmonary ultrasound

Other

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

Primary outcomes

  1. Area under the curve (AUC)

    Time frame: through the hospitalization, an average of 7 days

    The AUC of prediction model for SMPP

Secondary outcomes

  1. Sensitivity

    Time frame: through the hospitalization, an average of 7 days

    The sensitivity of prediction model for SMPP

  2. Specificity

    Time frame: through the hospitalization, an average of 7 days

    Specificity of prediction model for SMPP

  3. Positive prediction value (PPV)

    Time frame: through the hospitalization, an average of 7 days

    Positive prediction value (PPV) of prediction model for SMPP

  4. Negative prediction value (NPV)

    Time frame: through the hospitalization, an average of 7 days

    Negative prediction value (NPV) of prediction model for SMPP

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2026
Registry last updated
Jan 12, 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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