Drug-specific AntibodiesNCT05606302
A Multi-center Clinical Study of Drug Antibody and Precision Transfusion in China
An observational study of Drug-specific Antibodies, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug-specific Antibodies
- How many people
- 14,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with one or more of the antibiotics including piperacillin, amoxicillin, cefazolin, cefuroxime, ceftriaxone, cefoxitin sodium, and vancomycin.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang hospital of southern medical university
Guangzhou, Gaungdong
Huayou Zhou, doctor, 020-61641848, zohoyo@126.com
About this study
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.
Read the 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.
- Conditions
- Drug-specific Antibodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start1 Oct 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-specific AntibodiesStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 14,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606302
- Sponsor's protocol ID
- NFEC-2019-164
- Status last verified
- Jun 2022
- First submitted
- 2 Nov 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Clinical Study of Drug Antibody and Precision Transfusion in China
- ClinicalTrials.gov ID
- NCT05606302
- Acronym / sponsor ID
- NFEC-2019-164
- Conditions
- Drug-specific Antibodies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with one or more of the antibiotics including piperacillin, amoxicillin, cefazolin, cefuroxime, ceftriaxone, cefoxitin sodium, and vancomycin.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug-specific Antibodies, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huayou Zhou, Doctor (020-61641848, zohoyo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the positive rate of drug antibody between different drugs. (time frame: through study completion, an average of 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.