- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05606302
A Multi-center Clinical Study of Drug Antibody and Precision Transfusion in China
November 2, 2022 updated by: Nanfang Hospital of Southern Medical University
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Anticipated)
14000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Huayou Zhou, doctor
- Phone Number: 020-61641848
- Email: zohoyo@126.com
Study Locations
-
-
Gaungdong
-
Guangzhou, Gaungdong, China
- Recruiting
- Nanfang Hospital of Southern Medical University
-
Contact:
- Huayou Zhou, doctor
- Phone Number: 020-61641848
- Email: zohoyo@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare the positive rate of drug antibody between different drugs.
Time Frame: 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.
|
through study completion, an average of 3 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
November 2, 2022
First Submitted That Met QC Criteria
November 2, 2022
First Posted (Actual)
November 4, 2022
Study Record Updates
Last Update Posted (Actual)
November 4, 2022
Last Update Submitted That Met QC Criteria
November 2, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- NFEC-2019-164
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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