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

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.

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Key information

Conditions

Cytomegalovirus

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virologie, Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Allogeneic bone marrow transplant recipient or solid organ transplant recipient, included in the cohort at the time of its firs active CMV infection (ie biological signs of CMV replication (viremia, ADN or ARN aemia, Antigenaemiapp65….) with or without fever, or clinical end organ disease symptoms

Exclusion criteria

Patient without medical care.policy,
patient that did not signed the médical consent

Treatment and study plan

depistage

Biological

Virus 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

Primary outcomes

Resistance incidence in our patients with subgroup analysis, by organ and by the use of prophylaxis or preemptive treatment

Secondary outcomes

Strain diversity in baseline isolates and in resistant isolates Frequency of known resistance mutations Identification of new resistance-related mutations.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

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

Acronym: PHRC CMV

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2012
First posted: Nov 6, 2009
Registry last updated: Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed