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

Drug-specific Antibodies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05606302
• Other study ID #: NFEC-2019-164
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: June 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: Huayou Zhou, Doctor
• Phone: 020-61641848
• Email: zohoyo[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14000
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug-specific Antibodies

Locations

Country	Name	City	State
China	Nanfang hospital of southern medical university	Guangzhou	Gaungdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

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