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

  • STATUS
    Recruiting
  • End date
    Jul 25, 2023
  • participants needed
    150
  • sponsor
    Maimónides Biomedical Research Institute of Córdoba
Updated on 25 July 2021
ganciclovir
valganciclovir
dhpg

Summary

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

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.

Details
Condition Cytomegalic Inclusion Disease, Cytomegalovirus, Cytomegalovirus (CMV) Retinitis, Transplantation Infection, HCMV Infection, Cytomegalovirus Infections, cytomegalovirus infection, cmv infection
Treatment Ganciclovir, Valganciclovir
Clinical Study IdentifierNCT03699254
SponsorMaimónides Biomedical Research Institute of Córdoba
Last Modified on25 July 2021

Eligibility

Yes No Not Sure

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
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