Clinical trial of efficacy and safety of the combination of reduced duration prophylaxis followed by immuno-guided prophylaxis in lung transplant recipients.

Phase 1

• Conditions: Cytomegalovirus Infection in subjects who underwent lung transplantation.; MedDRA version: 20.1 Level: PT Classification code 10011831 Term: Cytomegalovirus infection System Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0 Level: PT Classification code 10010187 Term: Complications of transplanted lung System Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 20.0 Level: PT Classification code 10025127 Term: Lung transplant System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2018-003300-39-ES
• Lead Sponsor: Fundación para la Investigación Biomédica de Córdoba

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-25
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 150

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 127
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of reduced duration prophylaxis followed by immuno-guided prophylaxis to prevent cytomegalovirus disease.;Secondary Objective: In those subjects recruited within the experimental arm who develop citomegalovirus disease despite receiving the immuno-guided prophylaxis based on QF-reactive (cut-off point of 0.2 UI/mL), it will be assessed if a different cut-off point might predict the protection against the disease with greater reliability.;Primary end point(s): Cytomegalovirus disease incidence rate at 18 months after lung transplantation.;Timepoint(s) of evaluation of this end point: 18 months after lung transplantation.