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Transplantation InfectionPhase 3CYTOCORNCT03699254

Clinical Trial of Efficacy and Safety of the Combination of Reduced Duration Prophylaxis Followed by Immuno-guided Prophylaxis in Lung Transplant Recipients.

A Phase 3 study testing Valganciclovir and Ganciclovir in people with Transplantation Infection and Cytomegalovirus Infections, run by Maimónides Biomedical Research Institute of Córdoba at 7 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the efficacy of reduced duration prophylaxis followed by immuno-guided prophylaxis to prevent cytomegalovirus disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Valganciclovir and Ganciclovir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
7 sitesSpain
Study dates
5 Apr 2019to 29 May 2023
Phase
Phase 3
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

  • Subjects with cytomegalovirus positive serology who underwent lung transplantation.
  • Subjects of 18 years of age or older.
  • Expected valgancilovir prophylactic treatment of 6 months after transplantation.
  • Patients who have signed the informed consent form.

Who cannot join

  • HIV infected subjects.
  • Subjects unable to comply with the protocolo follow-up visits.
  • Subjects who underwent multivisceral transplant.
  • Pregnant and/or lactating women.
  • Intolerance to Valganciclovir/Ganciclovir treatment.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Spain7 sites

  • Hospital Universitario de A Coruña

    A Coruña, 15006

  • Hospital Universitario Vall D'Hebron

    Barcelona, 08035

  • Hospital Univesitario Reina Sofía

    Córdoba, 14004

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario La Fe

    Valencia, 46026

Other trials in Spain

About this study

Official title: Efficacy and Safety of the Combination of Reduced Duration Prophylaxis Followed by Immuno-guided Prophylaxis to Prevent Cytomegalovirus Disease in Lung Transplant Recipients (CYTOCOR STUDY): An Open-label, Randomised, Non-inferiority Clinical Trial.

To assess the efficacy of reduced duration prophylaxis followed by immuno-guided prophylaxis to prevent cytomegalovirus disease.

Read the detailed description

Prolonged use of antivirals to prevent the development of cytomegalovirus (CMV) disease in lung transplant patients has been shown to have significant side effects, for which alternatives are being sought to reduce their use. The monitoring of cell immunity against CMV could be an alternative as it has shown to be useful in identifying transplant patients at low risk of infection, who could benefit from shorter prophylaxis. The aim of the CYTOCOR study is to demonstrate that the combination of a reduced prophylaxis strategy with subsequent CMV-specific immunological monitoring would allow CMV infection to be controlled in lung transplant patients as effectively as the usual strategy (prophylaxis followed by pre-emptive therapy), while reducing the side effects of antivirals due to the shorter duration of prophylaxis.

Being tested
Valganciclovir, Ganciclovir
Keywords
Lung transplantation, Cytomegalovirus infection, Specific immunity
Medical subject headings
Cytomegalovirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ValganciclovirDrug

    Also called Valcyte

    Valganciclovir is a L-valyl ester of ganciclovir that exists as a mix of 2 diastereomers. After administration, both are converted to ganciclovir by esterases. Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, it inhibits replication of cytomegalovirus.

    In CMV-infected cells it's phosphorylated (phosphorylation is dependent on the viral kinase and occurs preferentially in virus-infected cells). Ganciclovir activity is due to inhibition of viral DNA synthesis by ganciclovir triphosphate.

  • GanciclovirDrug

    Also called Cymevene

    Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, it inhibits replication of cytomegalovirus.

    In CMV-infected cells it's phosphorylated (phosphorylation is dependent on the viral kinase and occurs preferentially in virus-infected cells). Ganciclovir activity is due to inhibition of viral DNA synthesis by ganciclovir triphosphate.

Study groups in NCT03699254
Study groupRoleWhat they receive
ControlActive comparatorControl Group (universal prophylaxis + pre-emptive therapy; 6+6): The recommendation of the Spanish Consensus Document will be followed according to the strategy described below: * Universal prophylaxis with valganciclovir (900 mg/24h, corrected for renal function) up to month +6. The use of associated immunotherapy (e.g., anti-CMV hyperimmune immunoglobulin) will depend on each center's clinical practice. During this period, the treatment of blips of viral replication detected during the usual clinical follow-up of patients will depend oneach center's clinical practice. * Pre-emptive therapy guided by viral load from month +6 to month +12. For a viral load above> 38 copies/mL (> 35 IU/mL) and depending on each center's clinical practice, treatment with valganciclovir may be initiated (900 mg/12h, corrected for renal function).
Receives: Drug: Valganciclovir; Drug: Ganciclovir
ExperimentalExperimentalExperimental Group (reduced prophylaxis + immuno-guided prophylaxis; 3+9): * Universal prophylaxis with valganciclovir (900 mg/24h, corrected for renal function) up to month +3. The use of associated immunotherapy (e.g., anti-CMV hyperimmune immunoglobulin) will depend oneach center's clinical practice. During this period, the treatment of blips of viral replication detected during the usual clinical follow-up of the patients will depend on the each center's clinical practice. * Immuno-guided prophylaxis. This will consist of a monthly determination of cellular immunity by QF-CMV from month +3 to month +12.
Receives: Drug: Valganciclovir; Drug: Ganciclovir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cytomegalovirus disease incidence rate at 18 months after lung transplantation.

    Cytomegalovirus disease incidence rate at 18 months after lung transplantation.

    Measured: 18 months after subject's transplantation.

Secondary outcomes (1)

  1. INFG cut-off point other than 0.2 IU/mL

    For patients of the experimental group (3+9) in which immuno-guided prophylaxis is used based on QF-CMV Reactive (cut-off 0.2 IU/mL of IFNG) and who develop CMV disease, a secondary objective will be to assess whether an INFG cut-off point other than 0.2 IU/mL could predict protection against the disease more reliably.

    Measured: 18 months after subject's transplantation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2018
  2. Study start5 Apr 2019
  3. Primary completion29 May 2023
  4. Study completion29 May 2023

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03699254
Sponsor's protocol ID
CYTOCOR
Other IDs
2018-003300-39, 2018
Acronym
CYTOCOR
Status last verified
Sep 2023
First submitted
5 Oct 2018
Last updated
15 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The individual participant data will be available. Individual parcicipant data that underlie the results reportes in this article, after deidenttification (text, tables, figures and appendices) The other documents that will be available: study protocol, Statistical Analysis Plan, Informed Consent Form. The data will be available beginning 9 months and ending 36 months following article publication. With whom? Researchers who provide a methodologically sound proposal. For what types of analyses? for individual participant data meta-analysis.

Publications

  • Paez-Vega A, Vaquero-Barrios JM, Ruiz-Arabi E, Iturbe-Fernandez D, Alonso R, Ussetti-Gil P, Monforte V, Pastor A, Fernandez-Moreno R, Mora VM, Erro-Iribarren M, Quezada CA, Berastegui C, Cifrian-Martinez JM, Cano A, Caston JJ, Machuca I, Lobo-Acosta MA, Gutierrez-Gutierrez B, Cantisan S, Torre-Cisneros J; CYTOCOR study group. Safety and efficacy of immunoguided prophylaxis for cytomegalovirus disease in low-risk lung transplant recipients in Spain: a multicentre, open-label, randomised, phase 3, noninferiority trial. Lancet Reg Health Eur. 2025 Mar 26;52:101268. doi: 10.1016/j.lanepe.2025.101268. eCollection 2025 May.

    PubMed 40224372

  • Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.

    PubMed 39807668

  • Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.

    PubMed 38700045

  • Gibson L. An Interferon-gamma Release Assay for Evaluation of Cell-mediated Immunity in Infants With Congenital Cytomegalovirus Infection. Clin Infect Dis. 2021 Aug 2;73(3):374-375. doi: 10.1093/cid/ciaa700. No abstract available.

    PubMed 32504089

  • Paez-Vega A, Cantisan S, Vaquero JM, Vidal E, Luque-Pineda A, Lobo-Acosta MA, Perez AB, Alonso-Moralejo R, Iturbe D, Monforte V, Otero-Gonzalez I, Pastor A, Ussetti P, Torre-Cisneros J. Efficacy and safety of the combination of reduced duration prophylaxis followed by immuno-guided prophylaxis to prevent cytomegalovirus disease in lung transplant recipients (CYTOCOR STUDY): an open-label, randomised, non-inferiority clinical trial. BMJ Open. 2019 Aug 15;9(8):e030648. doi: 10.1136/bmjopen-2019-030648.

    PubMed 31420397

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Valganciclovir and Ganciclovir in people with Transplantation Infection and Cytomegalovirus Infections, run by Maimónides Biomedical Research Institute of Córdoba at 7 sites in Spain.

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 4 inclusion and 5 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 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Spain. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Cytomegalovirus disease incidence rate at 18 months after lung transplantation. (time frame: 18 months after subject's transplantation.). 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 NCT03699254, which also lists 5 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 15 Sep 2023.

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