Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-23 @ 9:08 PM
Study NCT ID:
NCT02618057
Status:
UNKNOWN
Last Update Posted:
2018-04-27
First Post:
2015-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D011239', 'term': 'Prednisolone'}, {'id': 'D064704', 'term': 'Levofloxacin'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-26', 'studyFirstSubmitDate': '2015-11-08', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fever duration', 'timeFrame': 'within the first 14 days after intervention'}], 'secondaryOutcomes': [{'measure': 'Number of patients improved in chest X-ray', 'timeFrame': 'within the first 7 days after intervention'}, {'measure': 'Number of patients with side effect of steroid', 'timeFrame': 'within the first 14 days after intervention'}, {'measure': 'Number of patients improved in chest X-ray', 'timeFrame': 'within the first 14 days after intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mycoplasma Pneumoniae Pneumonia']}, 'descriptionModule': {'briefSummary': 'Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children.', 'detailedDescription': 'Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children. Participants will be randomly assigned (1:1 ratio) to receive either prednisone 1 mg/kg/d daily for 5 days or none. The primary endpoint was fever duration and analysed by intention to treat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Evidence of Mycoplasma pneumoniae infection\n* Lobar pneumonia or pneumoniae with pleural effusion\n\nExclusion Criteria:\n\n* Immunosuppresant host\n* Chronic cardiovascular/pulmonary disease\n* Hospital acquired infection'}, 'identificationModule': {'nctId': 'NCT02618057', 'briefTitle': 'Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia With Lobar Consolidation or Pleural Effusion in Children', 'orgStudyIdInfo': {'id': 'SNUH_P01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Steroid', 'description': 'Prednisolone, 1.0 mg/kg/day, PO, for 5 days Levofloxacin, 10mg/kg/day, IV, for 5days', 'interventionNames': ['Drug: Prednisolone', 'Drug: Levofloxacin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Levofloxacin, 10mg/kg/day, IV, for 5days', 'interventionNames': ['Drug: Levofloxacin']}], 'interventions': [{'name': 'Prednisolone', 'type': 'DRUG', 'otherNames': ['Solondo'], 'description': 'PO prednisolone, 1 mg/kg/day, for 5 days', 'armGroupLabels': ['Steroid']}, {'name': 'Levofloxacin', 'type': 'DRUG', 'description': 'Levofloxacin, 10mg/kg/day, IV, for 5days', 'armGroupLabels': ['Control', 'Steroid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ki Wook Yun, Prof.', 'role': 'CONTACT', 'email': 'pedwilly@snu.ac.kr', 'phone': '82-2-2072-4909'}], 'facility': "Seoul National University Children's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Ki Wook Yun, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'pedwilly@gmail.com', 'phone': '82-2-2072-4909'}], 'overallOfficials': [{'name': 'Eun Hwa Choi, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}