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New blood test may help protect kids from post-transplant infection

NCT ID NCT03924219

Knowledge-focused Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a blood test that measures immune response to CMV can predict infection risk in children who have received a heart, kidney, or liver transplant. Researchers tested blood samples from 161 children within the first year after transplant. The goal is to find immune response levels that indicate protection, which could help doctors decide how long to give antiviral drugs or how often to monitor for infection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CMV T cell Immunity Assay (blood test)
What this could lead to
If successful, this test could help doctors personalize antiviral treatment for children after transplant, reducing unnecessary medication and preventing infections.
What could go wrong
This is an observational study, not a treatment trial. The test may not accurately predict infection risk in all children, and results may not change current care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

161 people

The number who actually took part.

Started

Jun 2019

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pediatric patients \<18 years of age listed or anticipated to undergo kidney, heart, or liver transplantation.

Ages

0 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. \< 18 years of age at the time of pre-transplant enrollment 2. Potential subject is undergoing evaluation or is currently listed for isolated heart, kidney, or liver transplantation at a participating transplant center OR is anticipated to undergo living-donor kidney or liver transplantation 3. Anticipated to receive ≤ 200 days of antiviral chemoprophylaxis Note: Subjects who are consented, enrolled, and undergo transplantation at \<18 years of age will remain in the study and be followed post-transplant according to the study plan after they turn 18 years of age. Subjects will be re-consented to remain in the study at their first study visit after turning 18 years of age. Exclusion Criteria: I. Exclusion Criteria pre-transplant 1. Prior history of any organ transplant 2. Prior history of hematopoietic cell transplant 3. Anticipated to receive more than one organ at the time of transplant 4. Anticipated to receive \> 200 days of CMV antiviral chemoprophylaxis as part of the local transplant center's standard CMV prevention protocol 5. History of underlying primary (genetic) T cell immune deficiency II. Exclusion Criteria post-enrollment A) Removal from study due to minimal risk for CMV infection 1. CMV seronegative children \>= 12 months of age will be enrolled pre-transplant but will subsequently be excluded from the study IF they receive an organ from a CMV seronegative donor (CMV D-/R-). 2. Infants \<12 months will be considered seronegative regardless of their CMV IgG status (whether or not this testing was obtained by the local transplant center) UNLESS the infant has a positive pre-transplant CMV culture (from urine) or a positive pre-transplant CMV PCR (from urine, saliva, or blood). Infants \<12 months of age without evidence of prior CMV infection (as defined by these preceding criteria) will be excluded from post-transplant follow up IF they receive an organ from a CMV seronegative donor due to low risk for post-transplant CMV infection. Infants \<12 months of age with evidence of prior CMV infection (as defined above) will remain in the study following transplantation. B) Removal from study due to age a. Subjects who are enrolled at \<18 years of age but are not transplanted prior to their 18th birthday will be removed from the study and will not have further pre- or post-transplant follow up.

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Conditions

The condition(s) this trial relates to.

cytomegalovirus infection pyelonephritis renal infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CMV Heart transplant infection Kidney transplant infection Liver transplant infection

Contacts and locations

Locations

  • Albert Einstein College of Medicine/Children's Hospital at Montefiore

    New York, New York, 10467, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Duke University Medical Center/Duke Children's Hosptial

    Durham, North Carolina, 27710, United States

  • Emory University Medical Center/Children's Hospital of Atlanta

    Atlanta, Georgia, 30322, United States

  • Northwestern University Medical Center/Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Stanford University Medical Center/Lucile Packard Children's Hospital Stanford

    Stanford, California, 94305, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Pittsburgh Medical Center/Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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