Clinical trial NCT01008540: Prospective Multicentric Study of Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients
Official title: Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients in the Prophylaxis Era, a French Multicentric Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Resistance incidence in our patients with subgroup analysis, by organ and by the use of prophylaxis or preemptive treatment
Secondary outcomes:
measure: Strain diversity in baseline isolates and in resistant isolates Frequency of known resistance mutations Identification of new resistance-related mutations.
Other outcomes:
Locations:
city: Amiens
country: France
facility: Virologie
city: Angers
country: France
facility: Virologie
city: Besancon
country: France
facility: Virologie
city: Bobigny
country: France
facility: Virologie - Hôpital Avicenne
city: Bordeaux
country: France
facility: Virologie
city: Brest
country: France
facility: Virologie
city: Caen
country: France
facility: Virologie
city: Clermont Ferrand
country: France
facility: Virologie
city: Dijon
country: France
facility: Virologie
city: Fort de France
country: France
facility: Virologie
city: Grenoble
country: France
facility: Virologie
city: Lille
country: France
facility: Virologie
city: Limoges
country: France
facility: Bactériologie Virologie
city: Lyon
country: France
facility: Virologie
city: Montpellier
country: France
facility: Virologie
city: Nancy
country: France
facility: Virologie
city: Nantes
country: France
facility: Virologie
city: Nimes
country: France
facility: Virologie
city: Paris
country: France
facility: Virologie - Hôpital BICHAT
city: Paris
country: France
facility: Virologie - Hôpital La Pitié Salpétrière
city: Paris
country: France
facility: Virologie - Hôpital LARIBOISIERE
city: Paris
country: France
facility: Virologie - Hôpital NECKER
city: Paris
country: France
facility: Virologie - Hôpital SAINT-LOUIS
city: Poitiers
country: France
facility: Virologie
city: Reims
country: France
facility: Virologie
city: Rennes
country: France
facility: Virologie
city: Rouen
country: France
facility: Virologie
city: Saint-etienne
country: France
facility: Virologie
city: Strasbourg
country: France
facility: Virologie
city: Suresne
country: France
facility: Virologie
city: Toulouse
country: France
facility: Virologie
city: Tours
country: France
facility: Virologie
city: Villejuif
country: France
facility: Virologie - Hôpital Paul Brousse
Study officials:
affiliation: University Hospital, Limoges
name: ALAIN Sophie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Germi 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.
citation: Hantz 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.