ClinicalTrials.gg
Status unknownNCT05606302Updated Nov 4, 2022

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

An observational study in Drug-specific Antibodies, sponsored by Nanfang Hospital, Southern Medical University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2022-11-04.

Sponsored by Nanfang Hospital, Southern Medical University · Observational

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
14,000
Sex
All
01

Study 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 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.

02

Conditions studied

  • Drug-specific Antibodies
03

In context

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 488 studies on the registry; 213 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
14,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

    Time frame: through study completion, an average of 3 years.

07

Study locations

1 of 1 sites recruiting
  • Nanfang hospital of southern medical university
    Guangzhou, Gaungdong, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2021 (actual). Primary completion is estimated for Dec 2023, 26 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 2022
First posted
Nov 4, 2022
StartActual
Oct 1, 2021
Primary completionEst.
Dec 2023
CompletionEst.
Dec 2023
Last update
Nov 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05606302
Responsible party
Sponsor
First posted
Nov 4, 2022
Start date
Oct 1, 2021
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Nov 4, 2022

Study contacts

Huayou Zhou, Doctor
Contact
zohoyo@126.com
020-61641848

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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