Prospective Multicentric Study of Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients
PHRC CMV
Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients in the Prophylaxis Era, a French Multicentric Cohort Study
1 other identifier
interventional
800
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2006
Longer than P75 for not_applicable
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 5, 2009
CompletedFirst Posted
Study publicly available on registry
November 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJuly 20, 2025
July 1, 2025
4.3 years
November 5, 2009
July 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Resistance incidence in our patients with subgroup analysis, by organ and by the use of prophylaxis or preemptive treatment
Secondary Outcomes (1)
Strain diversity in baseline isolates and in resistant isolates Frequency of known resistance mutations Identification of new resistance-related mutations.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient without medical care.policy,
- patient that did not signed the médical consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Virologie
Amiens, 80, France
Virologie
Angers, 49, France
Virologie
Besançon, 25, France
Virologie - Hôpital Avicenne
Bobigny, 93, France
Virologie
Bordeaux, 33, France
Virologie
Brest, 29, France
Virologie
Caen, 14, France
Virologie
Clermont-Ferrand, 63, France
Virologie
Dijon, 21, France
Virologie
Fort de France, 97, France
Virologie
Grenoble, 38, France
Virologie
Lille, 59, France
Bactériologie Virologie
Limoges, 87042, France
Virologie
Lyon, 69, France
Virologie
Montpellier, 34, France
Virologie
Nancy, 54, France
Virologie
Nantes, 44, France
Virologie
Nîmes, 30, France
Virologie - Hôpital BICHAT
Paris, 75, France
Virologie - Hôpital La Pitié Salpétrière
Paris, 75, France
Virologie - Hôpital LARIBOISIERE
Paris, 75, France
Virologie - Hôpital NECKER
Paris, 75, France
Virologie - Hôpital SAINT-LOUIS
Paris, 75, France
Virologie
Poitiers, 86, France
Virologie
Reims, 51, France
Virologie
Rennes, 35, France
Virologie
Rouen, 76, France
Virologie
Saint-Etienne, 42, France
Virologie
Strasbourg, 67, France
Virologie
Suresne, 92, France
Virologie
Toulouse, 31, France
Virologie
Tours, 37, France
Virologie - Hôpital Paul Brousse
Villejuif, 94, France
Related Publications (3)
Andouard D, Mazeron MC, Ligat G, Couvreux A, Pouteil-Noble C, Cahen R, Yasdanpanah Y, Deering M, Viget N, Alain S, Hantz S. Contrasting effect of new HCMV pUL54 mutations on antiviral drug susceptibility: Benefits and limits of 3D analysis. Antiviral Res. 2016 May;129:115-119. doi: 10.1016/j.antiviral.2016.02.004. Epub 2016 Feb 10.
PMID: 26872863BACKGROUNDGermi R, Mariette C, Alain S, Lupo J, Thiebaut A, Brion JP, Epaulard O, Saint Raymond C, Malvezzi P, Morand P. Success and failure of artesunate treatment in five transplant recipients with disease caused by drug-resistant cytomegalovirus. Antiviral Res. 2014 Jan;101:57-61. doi: 10.1016/j.antiviral.2013.10.014. Epub 2013 Nov 1.
PMID: 24184983DERIVEDHantz S, Garnier-Geoffroy F, Mazeron MC, Garrigue I, Merville P, Mengelle C, Rostaing L, Saint Marcoux F, Essig M, Rerolle JP, Cotin S, Germi R, Pillet S, Lebranchu Y, Turlure P, Alain S; French CMV Resistance Survey Study Group. Drug-resistant cytomegalovirus in transplant recipients: a French cohort study. J Antimicrob Chemother. 2010 Dec;65(12):2628-40. doi: 10.1093/jac/dkq368. Epub 2010 Oct 20.
PMID: 20961907DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
ALAIN Sophie, MD
University Hospital, Limoges
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2009
First Posted
November 6, 2009
Study Start
August 1, 2006
Primary Completion
December 1, 2010
Study Completion
June 1, 2012
Last Updated
July 20, 2025
Record last verified: 2025-07