Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections

Bacteremia Clinical Trial

Official title:

Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05799716
• Other study ID #: CT20230313
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2023
• Source: Shanghai Changzheng Hospital
• Contact: Jinghui Yang
• Phone: 021-81885756
• Email: yjh[@]smmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn about the benefit of IVIG in donor-derived infections and the potential immunomodulatory effect on transplanted organs. The main questions it aims to answer are:

1. How effective IVIG is in preventing donor-derived infections

2. Does IVIG has potential immunomodulatory effect on transplanted organs

Description:

Donor-derived infections are defined as any infection present in the donor that is transmitted to one or more recipient. Donor-derived infections can be categorized into two groups: "expected" and "unexpected" infections. Expected transmissions occur when the donor is known to have an infection, as demonstrated by positive serology or nucleic acid test (NAT) result for cytomegalovirus (CMV), Epstein-Barr virus (EBV) or hepatitis B and C, or positive cultures in the donor at the time of donation. Unexpected transmissions may occur despite current screening strategies and are not expected in the donor at the time of organ placement.

Intravenous immunoglobulins (IVIG) are produced by pooling together of serum immunoglobulins from multiple donors, and are known to have powerful immunomodulatory and anti-inflammatory functions in vitro and in vivo. The goal of this study is to figure out the benefit of IVIG in donor-derived infections and the potential immunomodulatory effect on transplanted organs.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

Inclusion Criteria:

• Any person approved as a transplant donor with recipient who has never undergone a previous transplantation

• Transplant donor must be 6 years old or older

• They must have provided signed informed consent

• The donors must be willing to contribute samples of blood

Exclusion Criteria:

• Any potential transplant donor who is receiving or have received anti-herpes medication in the past week

• Any potential transplant donor to a recipient who has received a previous solid organ transplant

• Any potential transplant donor who is immunosuppressed due to medical disease and/or immunosuppressive or immunomodulating medications

• Any potential transplant donor who is on corticosteroids

Related Conditions & MeSH terms

• Acute Rejection of Renal Transplant
• Bacteremia
• Infections
• Viremia

Intervention

Drug:
• IVIG
0.5g/Kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Next-Generation Sequencing (NGS) Results of Bacteremia or Viremia in Transplant Recipient	NGS is a technology for determining the sequence of DNA or RNA to study genetic variation associated with diseases like bacteremia and viremia.	14 days
Primary	Incidence of Bacteremia or Viremia in Transplant Recipient		14 days
Secondary	Incidence of Acute Rejection in Transplant Recipient		1 month