Lung DiseasesNCT06494033
Prophylaxis Guided by Cytomegalovirus-specific T Cell Immunity to Prevent Cytomegalovirus Disease in Lung Transplant Recipients
An observational study of Lung Diseases, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the clinical outcomes of Cytomegalovirus (CMV) virus in the participants' body. Therefore, the study team will follow the participants' immunological response based on the Cytomegalovirus (CMV) virus testing. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Diseases
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants attending the Miami Transplant Institute.
Who may be able to join
- Adult patients over 18 years of age
- Lung transplant candidates with positive CMV IgG
- Anticipated to receive a lung transplant (both double lung and single lung)
Who cannot join
- Negative CMV IgG prior transplant
- Pregnant or breastfeeding women
- HIV infected patients
- Combined organ (e.g., lung-heart, lung-kidney) transplant candidates
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Yoichiro Natori, MD, 3053556323, yxn138@med.miami.edu
Lissett Moni, 3053555418, ltueros@med.miami.edu
About this study
Official title: Prophylaxis Guided by Cytomegalovirus-specific T Cell Immunity to Prevent Cytomegalovirus Disease in Lung Transplant Recipients: a Single Center Prospective Study
The purpose of this study is to evaluate the clinical outcomes of Cytomegalovirus (CMV) virus in the participants' body. Therefore, the study team will follow the participants' immunological response based on the Cytomegalovirus (CMV) virus testing.
- Conditions
- Lung Diseases
- Medical subject headings
- Lung Diseases
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 |
|---|---|---|
| Prophylaxis guided by Cytomegalovirus-specific T cell Immunity | The immunological response of participants in this group will be followed for 1 year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive CMV Immunoglobulin (IgG) positive lung transplant
Positive CMV Immunoglobulin (IgG) measured by IU/ml
Measured: Up to 1 year
Secondary outcomes (6)
Graft Outcome status
Graft Outcome status measured by number of rejection based on forced expiratory volume in 1 second( FEV1) /Forced vital capacity (FVC) ratio. A calculated ratio that helps diagnose obstructive and restrictive lung diseases
Measured: Up to 1 year
Number of dead participants
Number of dead participants measured by numbers of death
Measured: Up to 1 year
Duration of CMV medication
Duration of CMV medication measured by treatment days
Measured: Up to 1 year
Number of patients with CMV-positive results
CMV disease measured by the number of patients with CMV-positive results
Measured: Up to 1 year
Severity of CMV Disease
Severity of CMV disease measured by CMV polymerase chain reaction (PCR) (IU/mL)
Measured: Up to 1 year
Severity of Torque Teno virus
Severity of Torque Teno virus measured by Torque Teno virus (TTV) (BAU/ml)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start3 Jul 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Eurofins Viracor
- Responsible party
- Principal investigator, Yoichiro Natori, University of Miami
- Investigators
- Yoichiro Natori, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494033
- Sponsor's protocol ID
- 20230432
- Status last verified
- Mar 2026
- First submitted
- 2 Jul 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis Guided by Cytomegalovirus-specific T Cell Immunity to Prevent Cytomegalovirus Disease in Lung Transplant Recipients: a Single Center Prospective Study
- ClinicalTrials.gov ID
- NCT06494033
- Acronym / sponsor ID
- 20230432
- Conditions
- Lung Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Eurofins Viracor
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Jul 2024 (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 purpose of this study is to evaluate the clinical outcomes of Cytomegalovirus (CMV) virus in the participants' body. Therefore, the study team will follow the participants' immunological response based on the Cytomegalovirus (CMV) virus testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prophylaxis guided by Cytomegalovirus-specific T cell Immunity | – | –The immunological response of participants in this group will be followed for 1 year. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants attending the Miami Transplant Institute.
Key inclusion criteria (3 listed)
- Adult patients over 18 years of age
- Lung transplant candidates with positive CMV IgG
- Anticipated to receive a lung transplant (both double lung and single lung)
Key exclusion criteria (4 listed)
- Negative CMV IgG prior transplant
- Pregnant or breastfeeding women
- HIV infected patients
- Combined organ (e.g., lung-heart, lung-kidney) transplant candidates
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
Positive CMV Immunoglobulin (IgG) positive lung transplant
Time frame: Up to 1 year
Positive CMV Immunoglobulin (IgG) measured by IU/ml
6 secondary outcomes
Graft Outcome status
Time frame: Up to 1 year
Number of dead participants
Time frame: Up to 1 year
Duration of CMV medication
Time frame: Up to 1 year
Number of patients with CMV-positive results
Time frame: Up to 1 year
Severity of CMV Disease
Time frame: Up to 1 year
Severity of Torque Teno virus
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Yoichiro Natori, MD principal investigator
University of Miami
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 Lung Diseases, run by University of Miami at 1 site in United States.
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 4 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yoichiro Natori, MD (3053556323, yxn138@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive CMV Immunoglobulin (IgG) positive lung transplant (time frame: Up to 1 year). 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 23 Mar 2026.