Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05606302
Enrollment
14000
Registered
2022-11-04
Start date
2021-10-01
Completion date
2023-12-31
Last updated
2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-specific Antibodies

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.

Interventions

None listed

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

China

Contacts

Primary ContactHuayou Zhou, Doctor
zohoyo@126.com020-61641848

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026