Lung TransplantPREDICT CMVNCT03300882
PREDICT Cytomegalovirus (CMV)
An observational study of Lung Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in 2 countries.
Trial summary
The overall objective of this study is to establish a personalized test to measure individualized cytomegalovirus (CMV) specific immunity in lung transplant recipients in an effort to guide antiviral prophylaxis duration in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant
- What is being tested?
- Procedure
- How many people
- 84 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 31 Oct 2017to 25 Nov 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult lung transplant recipients undergoing lung transplant at one of the four participating centers and concurrently enrolled in CTOT-20 (Clinical Trials.gov ID: NCT02631720).
Who may be able to join
- Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- Must be able to understand and provide written informed consent;
- Anticipated listing for lung transplantation OR listed for lung transplant OR is within 45 days of having received a single or bilateral cadaveric donor lung transplant;
- Undergoing first lung transplant operation;
- Transplant surgery to be performed or performed at enrolling center;
- Concurrent participation in CTOT-20 (Clinical Trials.gov ID: NCT02631720); and
- CMV-seropositive lung transplant recipient, using methods in accordance with current local organ procurement organization policies.
- Note: Concurrent participation in immune monitoring studies or interventional device trials are permitted.
Who cannot join
- Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
- Unwilling to enroll in CTOT-20 (Clinical Trials.gov ID: NCT02631720);
- Multi-organ recipient;
- Prior recipient of any solid organ transplant, including prior lung transplant;
- Prior or concurrent recipient of bone marrow transplant;
- Human Immunodeficiency Virus (HIV) infection;
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- Pregnant or planned pregnancy;
- Any condition that, in the investigator's opinion, would make it unlikely for the recipient to complete follow up procedures or complete the study; or
- Participation in an investigational drug trial at the time of enrollment visit.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Johns Hopkins Hospital: Transplantation
Baltimore, Maryland, 21287
Cleveland Clinic Foundation: Transplantation
Cleveland, Ohio, 44195
Duke University Medical Center: Transplantation
Durham, North Carolina, 27710
About this study
Official title: Prospective Multicenter Cytomegalovirus (CMV) Specific Immune Monitoring to Predict Patient Risk After Lung Transplantation (CTOT-22)
The overall objective of this study is to establish a personalized test to measure individualized cytomegalovirus (CMV) specific immunity in lung transplant recipients in an effort to guide antiviral prophylaxis duration in clinical practice.
Targeted participants are those:
- enrolled in clinical research study CTOT-20 (Clinical Trials.gov ID: NCT02631720) who
- are CMV recipient positive by serology as determined using methods in accordance with current local organ procurement organization policies.
Read the detailed description
Cytomegalovirus (CMV) is a common virus. The virus is spread from one person to another through infected body fluids. In those with a normal immune system, CMV does not cause much of a problem. The immune system keeps the virus under control so most people do not have any symptoms. Once infected, the virus usually stays dormant (inactive) in the body for a person's entire life. This means some of the cells in the body are infected and the virus can become active again.
Lung transplant recipients take anti-rejection medicines to prevent the body from rejecting the transplanted lung(s). Although anti-rejection medications help protect the transplanted lung(s) from the body's immune system, these medications also decrease the body's ability to fight infections. This reduces the immune system's ability to control viruses like CMV. Many transplant recipients take an antiviral medication early after transplant to help the body control the CMV virus. This is the time that risk of infection would be highest. Sometimes recipients get an active CMV infection after stopping these medicines. If this happens, the infection is treated and monitored.
In this study, investigators are trying to determine whether a blood test can predict development of active CMV infection in lung transplant recipients. Specifically, the clinical research study will prospectively assess the performance of an immune signature based on the "ex vivo" measurement of T cell CMV specific immunity in predicting freedom from future CMV infections among recipient positive (R+) lung transplant participants receiving standard durations of valganciclovir prophylaxis.
- Conditions
- Lung Transplant
- Being tested
- Procedure
- Keywords
- Study co-enrollment (CTOT-20 and CTOT-22), cytomegalovirus (CMV), CMV seropositive positive recipient, CMV infection, CMV-specific immunity, immunologic monitoring
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProcedureOther
Also called Serial blood draws, Phlebotomy, Venipuncture
Serial blood draws. Participants will be enrolled either pre-transplant or within 45 days post-transplant and will be followed over the course of 18 months post transplant. Protocol mandated serial measurement of cytomegalovirus (CMV)-specific immune signature will occur pre-transplant (as applicable) and at post-transplant timepoint months 2, -3, -6, -9, -12 and -18.
| Study group | Role | What they receive |
|---|---|---|
| CMV+ First Lung Transplant Recipients | Participants enrolled in one of four North American sites in clinical research study CTOT-20 (Clinical Trials.gov ID: NCT02631720) who are cytomegalovirus positive by serology (e.g., CMV Recipient positive). Receives: Other: Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease within 6 months Post CMV Prophylaxis Discontinuation
Participants will be evaluated for CMV infection or disease according to each center's standard of care clinical protocol. All centers have aligned their clinical practice to include, at a minimum, a CMV infection and a CMV disease assessment at the time of prophylaxis discontinuation, monthly for the first 6 months after discontinuation, and quarterly after that up to 18 months post transplantation.
Measured: From CMV Prophylaxis Discontinuation to 6 Months Post CMV Prophylaxis Discontinuation
Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease Within 18 Months Post-Transplant
Participants will be evaluated for CMV infection or disease according to each center's standard of care clinical protocol. All centers have aligned their clinical practice to include, at a minimum, a CMV infection and a CMV disease assessment at the time of prophylaxis discontinuation, monthly for the first 6 months after discontinuation, and quarterly after that up to 18 months post transplantation.
Measured: From CMV Prophylaxis Discontinuation to 18-Months Post-Transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start31 Oct 2017
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Clinical Trials in Organ Transplantation, Rho Federal Systems Division, Inc.
- Responsible party
- Sponsor
- Investigators
- Laurie Snyder, MD, MHS, Study chair, Duke University Medical Center: TransplantationScott Palmer, MD, MHS, Study chair, Duke University Medical Center: Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300882
- Sponsor's protocol ID
- DAIT CTOT-22
- Other IDs
- NIAID CRMS ID#: 38277
- Acronym
- PREDICT CMV
- Status last verified
- Aug 2020
- First submitted
- 25 Sep 2017
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Snyder LD, Chan C, Kwon D, Yi JS, Martissa JA, Copeland CA, Osborne RJ, Sparks SD, Palmer SM, Weinhold KJ. Polyfunctional T-Cell Signatures to Predict Protection from Cytomegalovirus after Lung Transplantation. Am J Respir Crit Care Med. 2016 Jan 1;193(1):78-85. doi: 10.1164/rccm.201504-0733OC.
PubMed 26372850
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Cytomegalovirus (CMV) Specific Immune Monitoring to Predict Patient Risk After Lung Transplantation (CTOT-22)
- ClinicalTrials.gov ID
- NCT03300882
- Acronym / sponsor ID
- PREDICT CMV / DAIT CTOT-22
- Conditions
- Lung Transplant
- Keywords
- Study co-enrollment (CTOT-20 and CTOT-22), cytomegalovirus (CMV), CMV seropositive positive recipient, CMV infection, CMV-specific immunity, immunologic monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Clinical Trials in Organ Transplantation, Rho Federal Systems Division, Inc.
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 4 Oct 2017 (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.
The overall objective of this study is to establish a personalized test to measure individualized cytomegalovirus (CMV) specific immunity in lung transplant recipients in an effort to guide antiviral prophylaxis duration in clinical practice.
Targeted participants are those:
- enrolled in clinical research study CTOT-20 (Clinical Trials.gov ID: NCT02631720) who
- are CMV recipient positive by serology as determined using methods in accordance with current local organ procurement organization policies.
Detailed description
Cytomegalovirus (CMV) is a common virus. The virus is spread from one person to another through infected body fluids. In those with a normal immune system, CMV does not cause much of a problem. The immune system keeps the virus under control so most people do not have any symptoms. Once infected, the virus usually stays dormant (inactive) in the body for a person's entire life. This means some of the cells in the body are infected and the virus can become active again.
Lung transplant recipients take anti-rejection medicines to prevent the body from rejecting the transplanted lung(s). Although anti-rejection medications help protect the transplanted lung(s) from the body's immune system, these medications also decrease the body's ability to fight infections. This reduces the immune system's ability to control viruses like CMV. Many transplant recipients take an antiviral medication early after transplant to help the body control the CMV virus. This is the time that risk of infection would be highest. Sometimes recipients get an active CMV infection after stopping these medicines. If this happens, the infection is treated and monitored.
In this study, investigators are trying to determine whether a blood test can predict development of active CMV infection in lung transplant recipients. Specifically, the clinical research study will prospectively assess the performance of an immune signature based on the "ex vivo" measurement of T cell CMV specific immunity in predicting freedom from future CMV infections among recipient positive (R+) lung transplant participants receiving standard durations of valganciclovir prophylaxis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMV+ First Lung Transplant Recipients | – | Other: ProcedureParticipants enrolled in one of four North American sites in clinical research study CTOT-20 (Clinical Trials.gov ID: NCT02631720) who are cytomegalovirus positive by serology (e.g., CMV Recipient positive). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult lung transplant recipients undergoing lung transplant at one of the four participating centers and concurrently enrolled in CTOT-20 (Clinical Trials.gov ID: NCT02631720).
Key inclusion criteria (8 listed)
- Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- Must be able to understand and provide written informed consent;
- Anticipated listing for lung transplantation OR listed for lung transplant OR is within 45 days of having received a single or bilateral cadaveric donor lung transplant;
- Undergoing first lung transplant operation;
- Transplant surgery to be performed or performed at enrolling center;
Key exclusion criteria (9 listed)
- Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
- Unwilling to enroll in CTOT-20 (Clinical Trials.gov ID: NCT02631720);
- Multi-organ recipient;
- Prior recipient of any solid organ transplant, including prior lung transplant;
- Prior or concurrent recipient of bone marrow transplant;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProcedureAlso: Serial blood draws, Phlebotomy, VenipunctureSerial blood draws. Participants will be enrolled either pre-transplant or within 45 days post-transplant and will be followed over the course of 18 months post transplant. Protocol mandated serial measurement of cytomegalovirus (CMV)-specific immune signature will occur pre-transplant (as applicable) and at post-transplant timepoint months 2, -3, -6, -9, -12 and -18. | Other | CMV+ First Lung Transplant Recipients |
Primary outcome
Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease within 6 months Post CMV Prophylaxis Discontinuation
Time frame: From CMV Prophylaxis Discontinuation to 6 Months Post CMV Prophylaxis Discontinuation
Participants will be evaluated for CMV infection or disease according to each center's standard of care clinical protocol. All centers have aligned their clinical practice to include, at a minimum, a CMV infection and a CMV disease assessment at the time of prophylaxis discontinuation, monthly for the first 6 months after discontinuation, and quarterly after that up to 18 months post transplantation.
Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease Within 18 Months Post-Transplant
Time frame: From CMV Prophylaxis Discontinuation to 18-Months Post-Transplant
Participants will be evaluated for CMV infection or disease according to each center's standard of care clinical protocol. All centers have aligned their clinical practice to include, at a minimum, a CMV infection and a CMV disease assessment at the time of prophylaxis discontinuation, monthly for the first 6 months after discontinuation, and quarterly after that up to 18 months post transplantation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 26372850Snyder LD, Chan C, Kwon D, Yi JS, Martissa JA, Copeland CA, Osborne RJ, Sparks SD, Palmer SM, Weinhold KJ. Polyfunctional T-Cell Signatures to Predict Protection from Cytomegalovirus after Lung Transplantation. Am J Respir Crit Care Med. 2016 Jan 1;193(1):78-85. doi: 10.1164/rccm.201504-0733OC.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
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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.
Laurie Snyder, MD, MHS study chair
Duke University Medical Center: Transplantation
Scott Palmer, MD, MHS study chair
Duke University Medical Center: Transplantation
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in 2 countries.
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 8 inclusion and 9 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: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease within 6 months Post CMV Prophylaxis Discontinuation (time frame: From CMV Prophylaxis Discontinuation to 6 Months Post CMV Prophylaxis Discontinuation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03300882, which also lists 1 linked publication.
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 25 Sep 2026.