Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT05606302
Status:
UNKNOWN
Last Update Posted:
2022-11-04
First Post:
2022-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multi-center Clinical Study of Drug Antibody and Precision Transfusion in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2022-11-02', 'studyFirstSubmitQcDate': '2022-11-02', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the positive rate of drug antibody between different drugs.', 'timeFrame': 'through study completion, an average of 3 years.', 'description': 'The drug-induced hemolytic anemia test kit (microcolumn gel method) was used to determine whether drug antibodies were produced in the participates.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug-specific Antibodies']}, 'descriptionModule': {'briefSummary': 'Blood samples for hemolytic anemia in patients treated with one or more of the antibiotics including piperacillin, amoxicillin, cefazolin, cefuroxime, ceftriaxone, cefoxitin sodium, and vancomycin were screened for the production of drug antibodies.', 'detailedDescription': 'The widespread use of antibiotics and anti-tumor drugs in clinical practice leads to poor efficacy or even toxic side effects and other adverse events, which are often related to the immune response caused by the cells adsorption or binding because of the long-term use of drugs to cause the generation of antibodies or drug decomposition.The immune hemolytic anemia caused by antibiotics is more common.In this study, the remaining blood samples of patients who developed hemolytic anemia using one or more antibiotics including piperacillin, amoxicillin, cefazolin, cefuroxime, ceftriaxone, cefoxitin sodium and vancomycin were preliminarily screened to determine which drugs caused hemolytic anemia.The types of diseases and antibiotics used in patients with drug-induced hemolytic anemia were also analyzed.The positive rate of drug antibody production was calculated and the difference of drug antibody production mechanism was analyzed.The blood samples of the positive patients and some negative patients were collected and preserved to prepare for the follow-up study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with one or more of the antibiotics including piperacillin, amoxicillin, cefazolin, cefuroxime, ceftriaxone, cefoxitin sodium, and vancomycin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntary signing of informed consent;\n* No limitation on age or sex;No limitation on nationality;Regional unlimited;\n* Participates treated with one or more of the drugs including piperacillin, amoxicillin, cefazolin, cefuroxime, ceftriaxone, cefoxitin sodium, and vancomycin.\n\nExclusion Criteria:\n\n* High fat blood sample;\n* Sample of severe hemolysis;\n* Jaundice sample;\n* The sample is cloudy and may be contaminated with bacteria;\n* The source of the sample is unknown and cannot be traced;\n* Patients with a history of medication who were deemed inappropriate to participate in this study were evaluated by the researchers.'}, 'identificationModule': {'nctId': 'NCT05606302', 'briefTitle': 'A Multi-center Clinical Study of Drug Antibody and Precision Transfusion in China', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'A Multi-center Clinical Study of Drug Antibody and Precision Transfusion in China', 'orgStudyIdInfo': {'id': 'NFEC-2019-164'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Piperacillin group', 'description': 'Blood samples for hemolytic anemia in patients treated with piperacillin were screened for the production of drug antibodies.'}, {'label': 'Amoxicillin group', 'description': 'Blood samples for hemolytic anemia in patients treated with amoxicillin were screened for the production of drug antibodies.'}, {'label': 'Cefazolin group', 'description': 'Blood samples for hemolytic anemia in patients treated with cefazolin were screened for the production of drug antibodies.'}, {'label': 'Cefuroxime group', 'description': 'Blood samples for hemolytic anemia in patients treated with cefuroxime were screened for the production of drug antibodies.'}, {'label': 'Ceftriaxone group', 'description': 'Blood samples for hemolytic anemia in patients treated with ceftriaxone were screened for the production of drug antibodies.'}, {'label': 'Cefoxitin sodium group', 'description': 'Blood samples for hemolytic anemia in patients treated with cefoxitin sodium were screened for the production of drug antibodies.'}, {'label': 'Vancomycin group', 'description': 'Blood samples for hemolytic anemia in patients treated with vancomycin were screened for the production of drug antibodies.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Gaungdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huayou Zhou, doctor', 'role': 'CONTACT', 'email': 'zohoyo@126.com', 'phone': '020-61641848'}], 'facility': 'Nanfang hospital of southern medical university', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Huayou Zhou, Doctor', 'role': 'CONTACT', 'email': 'zohoyo@126.com', 'phone': '020-61641848'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}