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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01008540
Acronym
PHRC CMV
Enrollment
800
Registered
2009-11-06
Start date
2006-08-31
Completion date
2012-06-30
Last updated
2025-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus

Keywords

cytomegalovirus, resistance, transplantation, Patient coming to an French transplantation center for solid organ or bone marrow transplant, with information and signed consent

Brief 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.

Interventions

BIOLOGICALdepistage

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

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026