Clinical Trial of Efficacy and Safety of the Combination of Reduced Duration Prophylaxis Followed by Immuno-guided Prophylaxis in Lung Transplant Recipients. (CYTOCOR)
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ClinicalTrials.gov Identifier: NCT03699254 |
Recruitment Status :
Recruiting
First Posted : October 9, 2018
Last Update Posted : November 14, 2019
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Condition or disease | Intervention/treatment | Phase |
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Transplantation Infection Cytomegalovirus Infections | Drug: Valganciclovir Drug: Ganciclovir | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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. |
Actual Study Start Date : | April 5, 2019 |
Estimated Primary Completion Date : | April 2023 |
Estimated Study Completion Date : | July 2023 |

Arm | Intervention/treatment |
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Active Comparator: Control
Control Group (universal prophylaxis + pre-emptive therapy; 6+6): The recommendation of the Spanish Consensus Document will be followed according to the strategy described below:
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Drug: Valganciclovir
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. Other Name: Valcyte Drug: Ganciclovir 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. Other Name: Cymevene |
Experimental: Experimental
Experimental Group (reduced prophylaxis + immuno-guided prophylaxis; 3+9):
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Drug: Valganciclovir
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. Other Name: Valcyte Drug: Ganciclovir 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. Other Name: Cymevene |
- Cytomegalovirus disease incidence rate at 18 months after lung transplantation. [ Time Frame: 18 months after subject's transplantation. ]Cytomegalovirus disease incidence rate at 18 months after lung transplantation.
- INFG cut-off point other than 0.2 IU/mL [ Time Frame: 18 months after subject's transplantation. ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699254
Contact: Aurora Páez Vega | 0034957011040 | aurora.paez@imibic.org |
Spain | |
Hospital Universitario Marques de Valdecilla | Recruiting |
Santander, Cantabria, Spain, 39008 | |
Contact: David Iturbe Fernández, MD | |
Principal Investigator: David Iturbe Fernández, MD | |
Hospital Universitario Puerta de Hierro | Recruiting |
Majadahonda, Madrid, Spain, 28222 | |
Contact: Piedad Ussetti Gil, MD | |
Principal Investigator: Piedad Ussetti Gil, MD | |
Hospital Universitario de A Coruña | Recruiting |
A Coruña, Spain, 15006 | |
Contact: Isabel Otero González, MD | |
Principal Investigator: Isabel Otero González, MD | |
Hospital Universitario Vall D'Hebron | Recruiting |
Barcelona, Spain, 08035 | |
Contact: Victor Monforte Torres, MD | |
Principal Investigator: Victor Monforte Torres, MD | |
Hospital Univesitario Reina Sofía | Recruiting |
Córdoba, Spain, 14004 | |
Contact: Aurora Páez Vega 0034957011040 aurora.paez@imibic.org | |
Principal Investigator: Julián De la Torre Cisneros, MD | |
Hospital Universitario 12 de Octubre | Recruiting |
Madrid, Spain, 28041 | |
Contact: Rodrigo Alonso Moralejo, MD | |
Principal Investigator: Rodrigo Alonso Moralejo, MD | |
Hospital Universitario La Fe | Recruiting |
Valencia, Spain, 46026 | |
Contact: Amparo Pastor Colom, MD | |
Principal Investigator: Amparo Pastor Colom, MD |
Principal Investigator: | Julián de la Torre Cisneros, MD | Hospital Universitario Reina Sofía |
Responsible Party: | Maimónides Biomedical Research Institute of Córdoba |
ClinicalTrials.gov Identifier: | NCT03699254 |
Other Study ID Numbers: |
CYTOCOR 2018-003300-39 ( EudraCT Number ) |
First Posted: | October 9, 2018 Key Record Dates |
Last Update Posted: | November 14, 2019 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | The data will be available beginning 9 months and ending 36 months following article publication. |
Access Criteria: | To obtain the data, a proposal must be sent to uicec@imibic.org. To gain access, data requestors will need to sign a data access agreement. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Lung transplantation Cytomegalovirus infection Specific immunity |
Infection Communicable Diseases Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Valganciclovir |
Ganciclovir Ganciclovir triphosphate Antiviral Agents Anti-Infective Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |