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

NCT05606302 | Unknown

• 1 other identifier: NFEC-2019-164
• Study Type: observational
• Target: 14,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug-specific Antibodies

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (7)

Piperacillin group

Blood samples for hemolytic anemia in patients treated with piperacillin were screened for the production of drug antibodies.

Amoxicillin group

Blood samples for hemolytic anemia in patients treated with amoxicillin were screened for the production of drug antibodies.

Cefazolin group

Blood samples for hemolytic anemia in patients treated with cefazolin were screened for the production of drug antibodies.

Cefuroxime group

Blood samples for hemolytic anemia in patients treated with cefuroxime were screened for the production of drug antibodies.

Ceftriaxone group

Blood samples for hemolytic anemia in patients treated with ceftriaxone were screened for the production of drug antibodies.

Cefoxitin sodium group

Blood samples for hemolytic anemia in patients treated with cefoxitin sodium were screened for the production of drug antibodies.

Vancomycin group

Blood samples for hemolytic anemia in patients treated with vancomycin were screened for the production of drug antibodies.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with one or more of the antibiotics including piperacillin, amoxicillin, cefazolin, cefuroxime, ceftriaxone, cefoxitin sodium, and vancomycin.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang hospital of southern medical university

Guangzhou, Gaungdong, China

RECRUITING

Central Study Contacts

Huayou Zhou, Doctor

CONTACT

020-61641848; zohoyo@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 4, 2022
• Study Start: October 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 4, 2022

Record last verified: 2022-06

Locations

CN (1)