Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-01-02 @ 8:57 AM
Study NCT ID:
NCT04901104
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-05-25
First Post:
2021-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Prognosis of Patients With Sepsis After Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077596', 'term': 'Thymalfasin'}], 'ancestors': [{'id': 'D013947', 'term': 'Thymosin'}, {'id': 'D013951', 'term': 'Thymus Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-24', 'studyFirstSubmitDate': '2021-05-24', 'studyFirstSubmitQcDate': '2021-05-24', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'three years mortality', 'timeFrame': '3 years', 'description': 'Mortality rate of patients treated with thymosin α1 or placebo within 3 years'}], 'secondaryOutcomes': [{'measure': 'Recurrence rate of sepsis', 'timeFrame': '5 years', 'description': 'Percentage of recurrent sepsis within 5 years of discharge sepsis patients'}, {'measure': 'one year mortality', 'timeFrame': '1 year', 'description': 'Mortality rate of patients treated with thymosin α1 or placebo within 1 year'}, {'measure': 'Five years mortality', 'timeFrame': '5 years', 'description': 'Mortality rate of patients treated with thymosin α1 or placebo within 5 years'}, {'measure': 'short form 36 questionnaire', 'timeFrame': '1 year', 'description': 'Quality of life of sepsis patients after 1 year of thymosin α1 or placebo treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['long-term', 'thymosin alpha 1', 'sepsis', 'immunotherapy'], 'conditions': ['Long-term Effects of Thymosin Alpha 1 Treatment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://clinicaltrials.gov/ct2/show/study/NCT02867267', 'label': 'This study is a follow-up study of TESTS study'}]}, 'descriptionModule': {'briefSummary': 'Current clinical studies of thymosin α1 for sepsis have focused on short-term outcomes (28-day or 90-day mortality), and lack of clinical data on long-term outcomes (3 year mortality) of patients with sepsis after immunotherapy.\n\nBased on the preliminary clinical study (NCT02867267), this study will conduct long-term follow-up for sepsis patients to provide data support for the long-term prognosis of immunotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sepsis patients who discharged from hospital after recovery in the TESTS study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sepsis patients in the TESTS study Patients who discharged from hospital after recovery\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04901104', 'briefTitle': 'Long-term Prognosis of Patients With Sepsis After Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Long-term Prognosis After Thymosin Alpha 1 Treatment in Patients With Sepsis: A Multicenter Cohort Study', 'orgStudyIdInfo': {'id': 'Long-term prognosis in sepsis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'thymosin α1 group', 'description': 'The patient was treated with thymosin α1 in sepsis', 'interventionNames': ['Drug: Thymosin Alpha1']}, {'label': 'placebo group', 'description': 'The patient was treated without thymosin α1 in sepsis'}], 'interventions': [{'name': 'Thymosin Alpha1', 'type': 'DRUG', 'description': 'Drug interventions have been done in previous clinical studies', 'armGroupLabels': ['thymosin α1 group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jianfeng Wu', 'role': 'CONTACT', 'email': 'wujianf@mail.sysu.edu.cn', 'phone': '020-87755766-8453'}, {'name': 'Fei Pei', 'role': 'CONTACT', 'email': 'peif3@mail.sysu.edu.cn', 'phone': '020-87755766-8453'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Wu Jianfeng', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}