A Multi-center Clinical Study of Drug Antibody and Precision Transfusion in China

• Conditions: Drug-specific Antibodies

• Registration Number: NCT05606302
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-10-01
• Status Verified: 2022-06
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-02
• Last Update Submitted: 2022-11-02
• Study First Posted: 2022-11-04
• Last Update Posted: 2022-11-04
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14000

Inclusion Criteria

• Voluntary signing of informed consent;
• No limitation on age or sex;No limitation on nationality;Regional unlimited;
• Participates treated with one or more of the drugs including piperacillin, amoxicillin, cefazolin, cefuroxime, ceftriaxone, cefoxitin sodium, and vancomycin.

Exclusion Criteria

• High fat blood sample;
• Sample of severe hemolysis;
• Jaundice sample;
• The sample is cloudy and may be contaminated with bacteria;
• The source of the sample is unknown and cannot be traced;
• Patients with a history of medication who were deemed inappropriate to participate in this study were evaluated by the researchers.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the positive rate of drug antibody between different drugs.	through study completion, an average of 3 years.	The drug-induced hemolytic anemia test kit (microcolumn gel method) was used to determine whether drug antibodies were produced in the participates.

Trial Locations

Locations (1)

Nanfang hospital of southern medical university; 🇨🇳 Guangzhou, Gaungdong, China