Cytomegalovirus InfectionsNCT02538172
Cell-mediated Immunity for Prevention of CMV Disease
A study testing T-Track® CMV assay in people with Cytomegalovirus Infections, run by University of Lausanne Hospitals at 5 sites in Switzerland.
Trial summary
An open-label randomized controlled trial to adapt the duration of antiviral prophylaxis in D+/R- patients and in R+ patients receiving ATG according to the result of the T-Track® CMV assay. Investigators will include kidney and liver transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- T-Track® CMV assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 5 sitesSwitzerland
- Study dates
- Oct 2015to Jan 2021
- Phase
- Interventional
- 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
Who may be able to join
- 18 years old
- Kidney or liver transplantation
- Scheduled to receive CMV antiviral prophylaxis:
- CMV D+/R- patients
- Patients receiving lymphocyte-depleting antibodies (thymoglobulin® or ATG®)
Who cannot join
- Unable to provide informed consent
- Unable or unwilling to comply with study protocol
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Switzerland5 sites
Universität Basel
Basel, 4051
Universitätsspital Bern
Bern, 3010
Hopitaux Universitaires de Genève
Geneva, 1205
Kantonsspital St.Gallen
Sankt Gallen, 9007
UniversitätsSpital Zürich
Zurich, 8091
About this study
Official title: Monitoring of Specific Cytomegalovirus Cell-mediated Immunity (CMV-CMI) for Optimization of Preventive Strategies Against CMV Infection in High-risk Solid-organ Transplant Recipients
An open-label randomized controlled trial to adapt the duration of antiviral prophylaxis in D+/R- patients and in R+ patients receiving ATG according to the result of the T-Track® CMV assay. Investigators will include kidney and liver transplant recipients. Patients will be randomized during the first month post transplant.
In the interventional arm, while the patient is on antiviral prophylaxis, CMI will be monitored every 4 weeks from the 2nd month after transplant. Measurement of CMV CMI will be done in real time by using the T-Track® CMV assay. The continuation of antiviral prophylaxis will depend on the result of the assay:
Read more
- T-Track positive (patient at lower risk): discontinuation of the antiviral drug
- T-Track negative (patient at higher risk): continuation of the antiviral drug until the maximal duration of prophylaxis (3 to 6 months) The standard arm will receive a standard fixed duration of antiviral prophylaxis (3 months for R+ thymoglobulin treated-patients and 6 months for D+/R- patients). Measurement of CMV CMI by both T-Track® CMV and the Quantiferon-CMV® assays will be done at the same time points of the interventional arm, but the result will not be known by the investigators.
After discontinuation of prophylaxis, patients in both arms will be followed for the development of CMV replication at each visit using the local PCR assay and antiviral therapy will be administered in case of CMV infection according to local guidelines.
The co-primary endpoints will be the incidence of CMV disease or antiviral-treated CMV replication during the first 12 months post transplant AND the duration of antiviral prophylaxis.
- Conditions
- Cytomegalovirus Infections
- Being tested
- T-Track® CMV assay
- Keywords
- Cell-mediated immunity, Antiviral prophylaxis, Transplantation
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-Track® CMV assayOther
Also called Quantiferon-CMV® assays, Valganciclovir
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | T-Track® CMV assay Quantiferon-CMV® assays Valganciclovir Receives: Other: T-Track® CMV assay |
| Control | Other | T-Track® CMV assay Quantiferon-CMV® assays Valganciclovir Receives: Other: T-Track® CMV assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CMV infection
Measured: one year
Duration of antiviral prophylaxis
Measured: one year
Secondary outcomes (2)
Graft survival
Measured: one year
Incidence of CMV viremia using standardized measure
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2019
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oriol Manuel, University of Lausanne Hospitals
- Investigators
- Oriol Manuel, MD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538172
- Sponsor's protocol ID
- STCS FUP # 052
- Status last verified
- Apr 2021
- First submitted
- 26 Aug 2015
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Manuel O, Husain S, Kumar D, Zayas C, Mawhorter S, Levi ME, Kalpoe J, Lisboa L, Ely L, Kaul DR, Schwartz BS, Morris MI, Ison MG, Yen-Lieberman B, Sebastian A, Assi M, Humar A. Assessment of cytomegalovirus-specific cell-mediated immunity for the prediction of cytomegalovirus disease in high-risk solid-organ transplant recipients: a multicenter cohort study. Clin Infect Dis. 2013 Mar;56(6):817-24. doi: 10.1093/cid/cis993. Epub 2012 Nov 29.
PubMed 23196955Manuel O. Clinical Experience with Immune Monitoring for Cytomegalovirus in Solid-Organ Transplant Recipients. Curr Infect Dis Rep. 2013 Sep 29. doi: 10.1007/s11908-013-0369-6. Online ahead of print.
PubMed 24078428Humar A, Lebranchu Y, Vincenti F, Blumberg EA, Punch JD, Limaye AP, Abramowicz D, Jardine AG, Voulgari AT, Ives J, Hauser IA, Peeters P. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010 May;10(5):1228-37. doi: 10.1111/j.1600-6143.2010.03074.x. Epub 2010 Mar 26.
PubMed 20353469Manuel O, Laager M, Hirzel C, Neofytos D, Walti LN, Hoenger G, Binet I, Schnyder A, Stampf S, Koller M, Mombelli M, Kim MJ, Hoffmann M, Koenig K, Hess C, Burgener AV, Cippa PE, Hubel K, Mueller TF, Sidler D, Dahdal S, Suter-Riniker F, Villard J, Zbinden A, Pantaleo G, Semmo N, Hadaya K, Enriquez N, Meylan PR, Froissart M, Golshayan D, Fehr T, Huynh-Do U, Pascual M, van Delden C, Hirsch HH, Juni P, Mueller NJ; Swiss Transplant Cohort Study (STCS). Immune Monitoring-Guided Versus Fixed Duration of Antiviral Prophylaxis Against Cytomegalovirus in Solid-Organ Transplant Recipients: A Multicenter, Randomized Clinical Trial. Clin Infect Dis. 2024 Feb 17;78(2):312-323. doi: 10.1093/cid/ciad575.
PubMed 37738676
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Specific Cytomegalovirus Cell-mediated Immunity (CMV-CMI) for Optimization of Preventive Strategies Against CMV Infection in High-risk Solid-organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT02538172
- Acronym / sponsor ID
- STCS FUP # 052
- Conditions
- Cytomegalovirus Infections
- Keywords
- Cell-mediated immunity, Antiviral prophylaxis, Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 2 Sep 2015 (estimated)
- 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.
An open-label randomized controlled trial to adapt the duration of antiviral prophylaxis in D+/R- patients and in R+ patients receiving ATG according to the result of the T-Track® CMV assay. Investigators will include kidney and liver transplant recipients. Patients will be randomized during the first month post transplant.
In the interventional arm, while the patient is on antiviral prophylaxis, CMI will be monitored every 4 weeks from the 2nd month after transplant. Measurement of CMV CMI will be done in real time by using the T-Track® CMV assay. The continuation of antiviral prophylaxis will depend on the result of the assay:
- T-Track positive (patient at lower risk): discontinuation of the antiviral drug
- T-Track negative (patient at higher risk): continuation of the antiviral drug until the maximal duration of prophylaxis (3 to 6 months) The standard arm will receive a standard fixed duration of antiviral prophylaxis (3 months for R+ thymoglobulin treated-patients and 6 months for D+/R- patients). Measurement of CMV CMI by both T-Track® CMV and the Quantiferon-CMV® assays will be done at the same time points of the interventional arm, but the result will not be known by the investigators.
After discontinuation of prophylaxis, patients in both arms will be followed for the development of CMV replication at each visit using the local PCR assay and antiviral therapy will be administered in case of CMV infection according to local guidelines.
The co-primary endpoints will be the incidence of CMV disease or antiviral-treated CMV replication during the first 12 months post transplant AND the duration of antiviral prophylaxis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: T-Track® CMV assayT-Track® CMV assay Quantiferon-CMV® assays Valganciclovir |
| Control | Other | Other: T-Track® CMV assayT-Track® CMV assay Quantiferon-CMV® assays Valganciclovir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old
- Kidney or liver transplantation
- Scheduled to receive CMV antiviral prophylaxis:
- CMV D+/R- patients
- Patients receiving lymphocyte-depleting antibodies (thymoglobulin® or ATG®)
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Unable or unwilling to comply with study protocol
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 |
|---|---|---|
| T-Track® CMV assayAlso: Quantiferon-CMV® assays, Valganciclovir | Other | Control, Intervention |
Primary outcome
Incidence of CMV infection
Time frame: one year
Duration of antiviral prophylaxis
Time frame: one year
2 secondary outcomes
Graft survival
Time frame: one year
Incidence of CMV viremia using standardized measure
Time frame: one year
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 28 Apr 2021.
- Results publication: PubMed 23196955Manuel O, Husain S, Kumar D, Zayas C, Mawhorter S, Levi ME, Kalpoe J, Lisboa L, Ely L, Kaul DR, Schwartz BS, Morris MI, Ison MG, Yen-Lieberman B, Sebastian A, Assi M, Humar A. Assessment of cytomegalovirus-specific cell-mediated immunity for the prediction of cytomegalovirus disease in high-risk solid-organ transplant recipients: a multicenter cohort study. Clin Infect Dis. 2013 Mar;56(6):817-24. doi: 10.1093/cid/cis993. Epub 2012 Nov 29.
- Results publication: PubMed 24078428Manuel O. Clinical Experience with Immune Monitoring for Cytomegalovirus in Solid-Organ Transplant Recipients. Curr Infect Dis Rep. 2013 Sep 29. doi: 10.1007/s11908-013-0369-6. Online ahead of print.
- Results publication: PubMed 20353469Humar A, Lebranchu Y, Vincenti F, Blumberg EA, Punch JD, Limaye AP, Abramowicz D, Jardine AG, Voulgari AT, Ives J, Hauser IA, Peeters P. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010 May;10(5):1228-37. doi: 10.1111/j.1600-6143.2010.03074.x. Epub 2010 Mar 26.
- Derived from this study: PubMed 37738676Manuel O, Laager M, Hirzel C, Neofytos D, Walti LN, Hoenger G, Binet I, Schnyder A, Stampf S, Koller M, Mombelli M, Kim MJ, Hoffmann M, Koenig K, Hess C, Burgener AV, Cippa PE, Hubel K, Mueller TF, Sidler D, Dahdal S, Suter-Riniker F, Villard J, Zbinden A, Pantaleo G, Semmo N, Hadaya K, Enriquez N, Meylan PR, Froissart M, Golshayan D, Fehr T, Huynh-Do U, Pascual M, van Delden C, Hirsch HH, Juni P, Mueller NJ; Swiss Transplant Cohort Study (STCS). Immune Monitoring-Guided Versus Fixed Duration of Antiviral Prophylaxis Against Cytomegalovirus in Solid-Organ Transplant Recipients: A Multicenter, Randomized Clinical Trial. Clin Infect Dis. 2024 Feb 17;78(2):312-323. doi: 10.1093/cid/ciad575.
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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.
Oriol Manuel, MD principal investigator
University of Lausanne Hospitals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-Track® CMV assay in people with Cytomegalovirus Infections, run by University of Lausanne Hospitals at 5 sites in Switzerland.
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 5 inclusion and 2 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. 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?
Incidence of CMV infection (time frame: one year). 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 NCT02538172, which also lists 4 linked publications.
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 28 Apr 2021.