Clinical trial NCT02067169: A French Cohort of Transplant Recipients With CMV Infection : Risk Factors for Antiviral Resistance in the Prophylaxis Era.
Official title: A French Cohort of Transplant Recipients With CMV Infection : Risk Factors for Antiviral Resistance in the Prophylaxis Era. Survey of Pharmacological and Virological Resistance of Cytomegalovirus to Antiviral Therapy in Transplantation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transplant Recipients With CMV Infection
Keywords: Transplantation
CMV infection
antiviral resistance
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 408
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: allograft recipient or hematopoietic stem cell or solid organ.

Brief summary: Resistance to antivirals is a growing problem in transplantation.that may concerns up to 5% of patients treated for cytomegalovirus (CMV) syndrome or disease in recent per-protocol studies. This prevalence vary with the organ transplanted and the degree of viral replication and immunosuppression. Less data are available to date from real-life cohorts of patients, and there is no systematic survey of resistance in Europe or in the US. Non response to treatment concerns a larger group of patients and can result either from emergence of a resistant strain (virological resistance), from inadequate dosage of antivirals, or a high degree of immunosuppression, with a poor CMV immune response. The respective clinical impact of virological resistance and clinical resistance (of pharmacological or immunological origin) on graft outcome and long-term survival of patients has never been assessed. High viral loads and persistent replication associated to prolonged exposure to antivirals are known to favor the emergence of resistant strains. Though epidemiology of resistant strains, role of multiple infections, impact of various mutations on degree of resistance to antivirals and outcome remains to be further studied. Most studies are per-protocol studies or short-term studies conducted on limited populations. There are no data in real-life of transplanted patients at the era of enlarged prophylaxis except those from the French survey for cytomegalovirus resistance cohort opened at the end of 2006. From the first data collected on 346 patients we shown a 10,6% prevalence of non-response to therapy with 5,2% of virological resistance (6,1% incidence at one year on 214 patients) with a trend to poorer outcome in case of virological resistance and to the absence of impact of prophylaxis versus preemptive therapy, though larger populations and prolonged follow-up are requested to fulfill all objectives.

We therefore aim to constitute a prolonged survey cohort for CMV resistance with a large number of patients and a prolonged follow-up, to gather data on resistance to antivirals in real-life of transplant patients in an organized data bank, This cohort is in the continuum of our previous cohort started in 2006, granted by the Hospital Clinical Research Program Interregional (PHRC), with the same major objectives and prolonged follow-up of patients.


Eligibility criteria: Inclusion Criteria:

* allograft recipient with active CMV infection,
* or patient from the previous cohort, without opposition to biological collection of samples

Exclusion Criteria:

* not willing to participate, no health insurance

Primary outcomes:
measure: prevalence and incidence of resistance of cytomegalovirus
timeFrame: 3 weeks
Secondary outcomes:
measure: pharmacological and virological resistance
timeFrame: 2 years
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: Clichy
country: France
facility: AP-HP - Hôpital Beaujon - Virologie
city: Creteil
country: France
facility: AP-HP - Hôpital MONDOR - Virologie
city: Dijon
country: France
facility: Virologie
city: Grenoble
country: France
facility: Virologie
city: Le Plessis Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
city: Lille
country: France
facility: Virologie
city: Limoges
country: France
facility: Bactériologie Virologie
city: Lyon
country: France
facility: HCLYON - Virologie - Hôpital La Croix Rousse
city: Lyon
country: France
facility: Virologie
city: Marseille
country: France
facility: Virologie - AP-HM - La Timone
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: AP-HP - Hôpital Saint-Antoine - Virologie
city: Paris
country: France
facility: AP-HP - Hôpital Georges Pompidou - Virologie
city: Paris
country: France
facility: AP-HP - Hôpital TENON - 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 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: Toulouse
country: France
facility: Virologie
city: Tours
country: France
facility: Virologie
city: Villejuif
country: France
facility: Virologie - Hôpital Paul Brousse
Study officials:
affiliation: Limoges UH
name: Sophie ALAIN, MD
role: PRINCIPAL_INVESTIGATOR
References: