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Prospective Multicentric Study of Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients

NCT ID: NCT01008540

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cytomegalovirus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ALAIN Sophie, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

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Virologie

Amiens, , France

Site Status

Virologie

Angers, , France

Site Status

Virologie

Besançon, , France

Site Status

Virologie - Hôpital Avicenne

Bobigny, , France

Site Status

Virologie

Bordeaux, , France

Site Status

Virologie

Brest, , France

Site Status

Virologie

Caen, , France

Site Status

Virologie

Clermont-Ferrand, , France

Site Status

Virologie

Dijon, , France

Site Status

Virologie

Fort de France, , France

Site Status

Virologie

Grenoble, , France

Site Status

Virologie

Lille, , France

Site Status

Bactériologie Virologie

Limoges, , France

Site Status

Virologie

Lyon, , France

Site Status

Virologie

Montpellier, , France

Site Status

Virologie

Nancy, , France

Site Status

Virologie

Nantes, , France

Site Status

Virologie

Nîmes, , France

Site Status

Virologie - Hôpital BICHAT

Paris, , France

Site Status

Virologie - Hôpital La Pitié Salpétrière

Paris, , France

Site Status

Virologie - Hôpital LARIBOISIERE

Paris, , France

Site Status

Virologie - Hôpital NECKER

Paris, , France

Site Status

Virologie - Hôpital SAINT-LOUIS

Paris, , France

Site Status

Virologie

Poitiers, , France

Site Status

Virologie

Reims, , France

Site Status

Virologie

Rennes, , France

Site Status

Virologie

Rouen, , France

Site Status

Virologie

Saint-Etienne, , France

Site Status

Virologie

Strasbourg, , France

Site Status

Virologie

Suresne, , France

Site Status

Virologie

Toulouse, , France

Site Status

Virologie

Tours, , France

Site Status

Virologie - Hôpital Paul Brousse

Villejuif, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 26872863 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24184983 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20961907 (View on PubMed)

Other Identifiers

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I06016

Identifier Type: -

Identifier Source: org_study_id

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