Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT05768204
Status:
UNKNOWN
Last Update Posted:
2023-03-14
First Post:
2022-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research on the Treatment of Severe Community-acquired Pneumonia in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C009935', 'term': 'prednisolone acetate'}, {'id': 'D011239', 'term': 'Prednisolone'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2022-12-20', 'studyFirstSubmitQcDate': '2023-03-13', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rate of early treatment success', 'timeFrame': 'third day', 'description': 'temperature is normal, clinical manifestations are significantly improved, pulmonary signs are significantly improved or disappeared, and white blood cell\\\\C reactive protein\\\\procalcitonin returns to normal'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe pneumonia', 'children', 'glucocorticoid', 'Randomized Controlled Trial'], 'conditions': ['Severe Pneumonia']}, 'descriptionModule': {'briefSummary': 'The need for glucocorticoid therapy in children with severe community-acquired pneumonia in the acute phase of the disease remains unclear. The implementation of this study could provide strong evidence on the need for adjuvant glucose therapy in children with severe community-acquired pneumonia.', 'detailedDescription': "The use of glucocorticoid for severe community-acquired pneumonia in children is still controversial in clinic. There is still a lack of high quality clinical research results in this field. That's the purpose of this study. The study used oral glucocorticoids and placebos. It was a multicenter clinical study involving 160 people. The enrolled subjects were treated for 5 days after basic assessment, and the use of experimental drugs and changes in clinical manifestations and laboratory examination were strictly recorded. The possible adverse hormonal reactions such as hyperglycemia, hypertension and gastrointestinal ulcer bleeding should be closely monitored and appropriate treatment measures should be taken in time. Subject will be allowed to terminate the test if necessary. Record and discuss similar events. The double blind principle is strictly observed during the experiment to ensure the authenticity and reliability of the experimental data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 1 month-\\< 18 years old.\n2. Clinical diagnosis of community-acquired pneumonia (fever, cough, sputum, chest pain, dyspnea, abnormal breath sounds in the lungs, imaging pneumonia changes).\n3. Meet any of the following:\n\n * (1) the general condition is very poor;\n * (2) refusal to eat or dehydration;\n * (3) Significantly increased respiratory rate (70 times/min \\> infants, 50 times/min for older children\\>);\n * (4) dyspnea (three concave sign, moaning, nasal flapping)\n * (5) hypoxemia (cyanosis, transcutaneous oxygen saturation\\< 92% (not oxygenated));\n * (6) Pulmonary infiltration≥ 2/3 lung or multilobar infiltration;\n * (7) There is a pleural effusion;\n * (8) Extrapulmonary complications\n\nExclusion Criteria:\n\n1. Systemic corticosteroids have been used to treat pneumonia before admission.\n2. Use systemic glucocorticoids within 3 months before admission.\n3. Hospital-acquired pneumonia.\n4. Children with history of tuberculosis, branch expansion, tumors, immune deficiency, congenital heart, chronic pulmonary heart disease, kidney disease, severe malnutrition, recurrent respiratory infections, congenital bronchopulmonary dysplasia (BPD) and other underlying diseases.\n5. Unconscious, need endotracheal intubation, children admitted to ICU.\n6. Those who are allergic to the drugs or their preparation components involved in the study.\n7. Those with hormonal contraindications: hypertension, diabetes, active peptic ulcer, adrenal hyperfunction, corneal ulcer, increased intraocular pressure, severe psychosis.\n8. There is a current infection that is difficult to control with antibacterial drugs.\n9. Children who are participating in other clinical trials.\n10. The investigator believes that it is not suitable to participate in the study.'}, 'identificationModule': {'nctId': 'NCT05768204', 'briefTitle': 'Research on the Treatment of Severe Community-acquired Pneumonia in Children', 'organization': {'class': 'OTHER', 'fullName': "Beijing Children's Hospital"}, 'officialTitle': 'Research on the Treatment of Severe Community-acquired Pneumonia in Children', 'orgStudyIdInfo': {'id': 'BCH lung 020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Prednisolone, oral, 2 mg/kg.d (maximum dose 60 mg/day), two or three times a day , 5 days.', 'interventionNames': ['Drug: Prednisolone Acetate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'The same amount of placebo was taken orally as the trial for 5 days', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Prednisolone Acetate', 'type': 'DRUG', 'otherNames': ['Prednisolone'], 'description': 'The experimental group took prednisolone acetate which is a kind of oral glucocorticoid.', 'armGroupLabels': ['Experimental group']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'A placebo consistent in appearance with the prednisolone acetate.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baoding', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'he zhang, master', 'role': 'CONTACT'}], 'facility': "Baoding Children's Hospital", 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yongkang wang, bachelor', 'role': 'CONTACT'}], 'facility': "Beijing Children's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jianxin He, doctor', 'role': 'CONTACT'}], 'facility': 'Beijing Fangshan District Health Care Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Baoping Xu', 'role': 'CONTACT', 'email': 'xubaopingbch@163.com', 'phone': '13370115002'}], 'overallOfficials': [{'name': 'Baoping Xu', 'role': 'STUDY_DIRECTOR', 'affiliation': "Beijing Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baoping XU', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Baoping XU', 'investigatorAffiliation': "Beijing Children's Hospital"}}}}