Clinical Trials Directory

Trials / Completed

CompletedNCT01008540

Prospective Multicentric Study of Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients

Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients in the Prophylaxis Era, a French Multicentric Cohort Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
800 (estimated)
Sponsor
University Hospital, Limoges · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

The investigators aim is to determine the incidence of cytomegalovirus resistance to antivirals in a cohort study. The patients are included at their first CMV active infection and are followed during two years thereafter. When criteria for suspected resistance are meet, blood and urine samples are collected for virus isolation and further resistance phenotype, and for resistance genotype determination. Results are compared with baseline samples. Clinical information such as treatment, immunosuppressive regimen and clinical evolution will be collected. Through this study, the investigators aim to organize a national network for the detection and identification of CMV resistant strains that will be useful when new therapeutics will be available.

Conditions

Interventions

TypeNameDescription
BIOLOGICALdepistageVirus isolation from urine, blood, or any suitable sample in case of CMV disease Resistance phenotype to antivirals UL97 and UL54 genes sequencing from blood, urines or any suitable samples for resistance mutations detection and polymorphism study

Timeline

Start date
2006-08-01
Primary completion
2010-12-01
Completion
2012-06-01
First posted
2009-11-06
Last updated
2025-07-20

Locations

33 sites across 1 country: France

Source: ClinicalTrials.gov record NCT01008540. Inclusion in this directory is not an endorsement.