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

Maimónides Biomedical Research Institute of Córdoba

Status and phase: Completed; Phase 3

Conditions: Transplantation Infection; Cytomegalovirus Infections

Treatments: Drug: Valganciclovir; Drug: Ganciclovir

Study type: Interventional

Funder types: Other

Identifiers

NCT03699254

CYTOCOR

2018-003300-39 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Control

Active Comparator group

Description:

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: * 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).

Treatment:

Drug: Ganciclovir

Drug: Valganciclovir

Experimental

Experimental group

Description:

Experimental 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.

Treatment:

Drug: Ganciclovir

Drug: Valganciclovir