Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:35 PM
Study NCT ID:
NCT07333833
Status:
COMPLETED
Last Update Posted:
2026-01-12
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Validation of an Early Prediction Model for Severe Mycoplasma Pneumoniae Pneumonia in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011019', 'term': 'Pneumonia, Mycoplasma'}], 'ancestors': [{'id': 'D009175', 'term': 'Mycoplasma Infections'}, {'id': 'D009180', 'term': 'Mycoplasmatales Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018410', 'term': 'Pneumonia, Bacterial'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 964}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-09', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2026-01-09', 'lastUpdatePostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve (AUC)', 'timeFrame': 'through the hospitalization, an average of 7 days', 'description': 'The AUC of prediction model for SMPP'}], 'secondaryOutcomes': [{'measure': 'Sensitivity', 'timeFrame': 'through the hospitalization, an average of 7 days', 'description': 'The sensitivity of prediction model for SMPP'}, {'measure': 'Specificity', 'timeFrame': 'through the hospitalization, an average of 7 days', 'description': 'Specificity of prediction model for SMPP'}, {'measure': 'Positive prediction value (PPV)', 'timeFrame': 'through the hospitalization, an average of 7 days', 'description': 'Positive prediction value (PPV) of prediction model for SMPP'}, {'measure': 'Negative prediction value (NPV)', 'timeFrame': 'through the hospitalization, an average of 7 days', 'description': 'Negative prediction value (NPV) of prediction model for SMPP'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['severe mycoplasma pneumoniae pneumonia'], 'conditions': ['Mycoplasma Pneumoniae Pneumonia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 1 month to 14 years\n* diagnosed with Mycoplasma pneumoniae pneumonia\n* hospital stay ≥ 72 hours\n\nExclusion Criteria:\n\n* pulmonary chronicles\n* cardiovascular conditions\n* inherited metabolic disorders\n* immuno-deficiency disorders\n* coinfection with pathogens other than Mycoplasma pneumoniae'}, 'identificationModule': {'nctId': 'NCT07333833', 'briefTitle': 'Development and Validation of an Early Prediction Model for Severe Mycoplasma Pneumoniae Pneumonia in Children', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'Development and Validation of an Early Prediction Model for Severe Mycoplasma Pneumoniae Pneumonia in Children', 'orgStudyIdInfo': {'id': 'V120250926'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Development', 'description': 'A primary cohort of eligible patients from the Beijing Friendship Hospital between 2018-1-1 and 2024-5-31 is used for model derivation.', 'interventionNames': ['Other: medical history taking, blood test, pulmonary ultrasound']}, {'label': 'Internal cross-validation', 'description': 'A cohort of consecutive patients from the Beijing Friendship Hospital between 2018-1-1 and 2024-5-31 is used for internal cross-validation.', 'interventionNames': ['Other: medical history taking, blood test, pulmonary ultrasound']}, {'label': 'External validation', 'description': 'A cohort of patients from the Beijing Friendship Hospital between 2024-6-1 and 2025-6-30 is used for internal cross-validation.', 'interventionNames': ['Other: medical history taking, blood test, pulmonary ultrasound']}], 'interventions': [{'name': 'medical history taking, blood test, pulmonary ultrasound', 'type': 'OTHER', 'description': 'medical history taking, blood test, pulmonary ultrasound are used for MPP and SMPP diagnosis', 'armGroupLabels': ['Development', 'External validation', 'Internal cross-validation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}