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A French Cohort of Transplant Recipients With CMV Infection : Risk Factors for Antiviral Resistance in the Prophylaxis Era. (ORPHAVIC)

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: NCT02067169
Recruitment Status : Completed
First Posted : February 20, 2014
Last Update Posted : July 4, 2018
Information provided by (Responsible Party):
University Hospital, Limoges

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.

Condition or disease Intervention/treatment
Transplant Recipients With CMV Infection Biological: CMV Infection

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Study Type : Observational
Actual Enrollment : 408 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : January 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
CMV infection
allograft recipient with active CMV infection
Biological: CMV Infection
Routine follow-up (viral load, creatininaemia, neutrophil count, isolation of CMV strains when possible) and biological sample collection for . Resistance testing towards any antiviral available by genotype and phenotype (when an isolate is obtained) when resistance criteria are fulfilled. Plasma collection at treatment initiation, and in case of neutropenia, for antiviral dosage.

Primary Outcome Measures :
  1. prevalence and incidence of resistance of cytomegalovirus [ Time Frame: 3 weeks ]
    Non response to therapy is defined as persistent viral replication after more than 3 weeks of appropriate antiviral treatment, with or without clinical manifestations.

Secondary Outcome Measures :
  1. pharmacological and virological resistance [ Time Frame: 2 years ]
    Measure the respective incidence of pharmacological and virological resistance

Biospecimen Retention:   Samples Without DNA
Detection of the CMV in sang, the leukocytes, or plasma with or without the viral quantification and/or the sample of urine of saliva or tissues, positive for research of CMV.

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
Sampling Method:   Non-Probability Sample
Study Population
allograft recipient or hematopoietic stem cell or solid organ.

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

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): NCT02067169

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Amiens, France, 80
Angers, France, 49
Besancon, France, 25
Virologie - Hôpital Avicenne
Bobigny, France, 93
Bordeaux, France, 33
Brest, France, 29
Caen, France, 14
Clermont Ferrand, France, 63
AP-HP - Hôpital Beaujon - Virologie
Clichy, France, 92118
AP-HP - Hôpital MONDOR - Virologie
Creteil, France, 94010
Dijon, France, 21
Grenoble, France, 38
Centre Chirurgical Marie Lannelongue
Le Plessis Robinson, France, 92350
Lille, France, 59
Bactériologie Virologie
Limoges, France, 87042
HCLYON - Virologie - Hôpital La Croix Rousse
Lyon, France, 69314
Lyon, France, 69
Virologie - AP-HM - La Timone
Marseille, France, 13385
Montpellier, France, 34
Nancy, France, 54
Nantes, France, 44
Nimes, France, 30
AP-HP - Hôpital Saint-Antoine - Virologie
Paris, France, 75571
AP-HP - Hôpital Georges Pompidou - Virologie
Paris, France, 75908
AP-HP - Hôpital TENON - Virologie
Paris, France, 75970
Virologie - Hôpital BICHAT
Paris, France, 75
Virologie - Hôpital La Pitié Salpétrière
Paris, France, 75
Virologie - Hôpital NECKER
Paris, France, 75
Virologie - Hôpital SAINT-LOUIS
Paris, France, 75
Poitiers, France, 86
Reims, France, 51
Rennes, France, 35
Rouen, France, 76
Saint-etienne, France, 42
Strasbourg, France, 67
Toulouse, France, 31
Tours, France, 37
Virologie - Hôpital Paul Brousse
Villejuif, France, 94
Sponsors and Collaborators
University Hospital, Limoges
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Principal Investigator: Sophie ALAIN, MD Limoges UH

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Responsible Party: University Hospital, Limoges Identifier: NCT02067169     History of Changes
Other Study ID Numbers: I09013 ORPHAVIC
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018

Keywords provided by University Hospital, Limoges:
CMV infection
antiviral resistance

Additional relevant MeSH terms:
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Communicable Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Antiviral Agents
Anti-Infective Agents