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Prospective Multicentric Study of Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients (PHRC CMV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01008540
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : September 5, 2016
Information provided by (Responsible Party):
University Hospital, Limoges

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.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Biological: depistage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients in the Prophylaxis Era, a French Multicentric Cohort Study
Study Start Date : August 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : June 2012

Intervention Details:
  • Biological: depistage
    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 Outcome Measures :
  1. Resistance incidence in our patients with subgroup analysis, by organ and by the use of prophylaxis or preemptive treatment

Secondary Outcome Measures :
  1. Strain diversity in baseline isolates and in resistant isolates Frequency of known resistance mutations Identification of new resistance-related mutations.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01008540

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Sponsors and Collaborators
University Hospital, Limoges
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Principal Investigator: ALAIN Sophie, MD University Hospital, Limoges
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Limoges Identifier: NCT01008540    
Other Study ID Numbers: I06016
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016
Keywords provided by University Hospital, Limoges:
Patient coming to an French transplantation center for solid organ or bone marrow transplant, with information and signed consent