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

NCT ID: NCT05606302

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

14000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Drug-specific Antibodies

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Piperacillin group

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

No interventions assigned to this group

Amoxicillin group

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

No interventions assigned to this group

Cefazolin group

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

No interventions assigned to this group

Cefuroxime group

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

No interventions assigned to this group

Ceftriaxone group

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

No interventions assigned to this group

Cefoxitin sodium group

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

No interventions assigned to this group

Vancomycin group

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

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanfang hospital of southern medical university

Guangzhou, Gaungdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huayou Zhou, Doctor

Role: CONTACT

020-61641848

Facility Contacts

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Huayou Zhou, doctor

Role: primary

020-61641848

Other Identifiers

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NFEC-2019-164

Identifier Type: -

Identifier Source: org_study_id

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