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

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Collaborator: Instituto de Salud Carlos III
• Treatments: Ganciclovir; Ganciclovir triphosphate; Valganciclovir

Criteria

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.