Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-03-02 @ 10:04 PM
Study NCT ID:
NCT03617393
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2018-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Appropriate Technology of Standardized Diagnosis and Treatment for Diabetic Patients With Pulmonary Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-07', 'studyFirstSubmitDate': '2018-07-12', 'studyFirstSubmitQcDate': '2018-07-31', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival at 30 Days', 'timeFrame': '30 days from date of diagnosis of pulmonary infection until the date of death from any cause.', 'description': 'Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual 30-day-survival of patients from different groups.'}, {'measure': 'Survival at 90 Days', 'timeFrame': '90 days from date of diagnosis of pulmonary infection until the date of death from any cause.', 'description': 'Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual 90-day-survival of patients from different groups.'}, {'measure': 'Survival at 1 Year', 'timeFrame': '1 year from date of diagnosis of pulmonary infection until the date of death from any cause.', 'description': 'Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual 1-year-survival of patients from different groups.'}], 'secondaryOutcomes': [{'measure': 'Hospitalization Time', 'timeFrame': 'Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years', 'description': 'Differences in the time of hospital stay including ordinary sickroom and ICU of patients from different groups.'}, {'measure': 'Sepsis', 'timeFrame': 'Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years', 'description': 'Differences in the primary and secondary sepsis after therapy according to guideline from different groups.'}, {'measure': 'CURB-65 Score', 'timeFrame': 'Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years', 'description': 'Differences in confusion, urea, respiratory rate and age 65 scoring system from different groups.'}, {'measure': 'Inflammatory Parameters', 'timeFrame': 'Day 0, day 3, day 10-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years', 'description': 'Differences in CRP, PCT, IL-6, IL-8, TNF-α from different groups.'}, {'measure': 'Fungal Infection Examinations', 'timeFrame': 'Day 0, day 3, day 10-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years', 'description': 'Assessment of G test and GM test in order to clarify the diagnosis of fungal infection.'}, {'measure': 'Cryptococcal Infection Examinations', 'timeFrame': 'Day 0, day 3, day 10-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years', 'description': 'Assessment latex agglutination test in order to clarify the cryptococcal infection.'}, {'measure': 'Cell-mediated Immunoserologic Indexs', 'timeFrame': 'Day 0, day 3, day 10-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years', 'description': 'Differences of CD3, CD4 and CD8 in different groups in order to research on cell-mediated immunity of patients with or without diabetes and pulmonary infection.'}, {'measure': 'Humoral Immunoserologic Indexes', 'timeFrame': 'Day 0, day 3, day 10-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years', 'description': 'Differences of IgG, IgA, IgE and IgM in different groups in order to research on cell-mediated immunity of patients with or without diabetes and pulmonary infection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early Warning Model', 'Clinical Pathway', 'Diabetes', 'Pulmonary Infection'], 'conditions': ['Diabetes Mellitus', 'Pulmonary Infection']}, 'descriptionModule': {'briefSummary': 'Focusing on patients with diabetes complicated with pulmonary infection, the purpose of this study is: 1) to identify the epidemiology, etiologic spectrum and status of diagnosis and treatment; 2) to develop a symptom score scale , clarify the risk factors and create a precise warning model; 3) to develop a rapid detection of pathogen of lower respiratory infection, to establish clinical pathways of early diagnosis and treatment of diabetes complicated with pulmonary infections (including bacterial, tuberculosis and fungal infections) and then make an application in clinic.', 'detailedDescription': 'Investigators perform a observational study on 6000 patients with diabetes, among which 200 patients with pulmonary infection are included in a retrospective study and 100 patients go through metabolomics research. All patients receive clinical questionnaires, laboratory examinations and pulmonary function tests. Investigators study on pathogen distribution and infection ratio of patients above depending on follow-up survey. 1:1 nested case-control study is carried out involving 100 cases from pulmonary-infected group paired with 100 control cases matched for gender, age and fasting blood-glucose. The final purpose is to create a precise warning model in order to develop a rapid detection of pathogen of lower respiratory infection in diabetes patients. Now investigators wish to register this study to do a further research, in order to improve the early diagnosis of diabetes complicated with pulmonary infection and to reduce the mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'diabetes patients complicated with pulmonary infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis by pathogen examination: positive\n* Diagnosis through X-ray or CT: characteristic features of pulmonary infection\n* Diagnosis through guideline of diabetes or history of diagnosed diabetes\n* Age 40-70 years\n\nExclusion Criteria:\n\n* Irregular follow-up and lost follow-up\n* Withdraw from the study for any reason'}, 'identificationModule': {'nctId': 'NCT03617393', 'briefTitle': 'Study on Appropriate Technology of Standardized Diagnosis and Treatment for Diabetic Patients With Pulmonary Infections', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'A Prospective Study of Appropriate Technology of Standardized Diagnosis and Treatment for Diabetic Patients With Complication of Pulmonary Infection', 'orgStudyIdInfo': {'id': '2017YFC1309700'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulmonary Infection with DM group', 'description': 'Patients with diabetes and pulmonary infection.'}, {'label': 'Pulmonary Infection group', 'description': 'Patients with pulmonary infection while the fasting blood-glucose in the normal range.'}, {'label': 'DM group', 'description': 'Patients without pulmonary infection while the fasting blood-glucose \\> 8 mmol/L.'}, {'label': 'Control group: normal people', 'description': 'Patients without pulmonary infection while the fasting blood-glucose in the normal range.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Jieming QU, Ph.D., M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China, Shanghai Ruijin Hospital Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician of Department of Respiratory Medicine', 'investigatorFullName': 'ZHOU Min', 'investigatorAffiliation': 'Ruijin Hospital'}}}}