Prospective Multicentric Study of Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients (PHRC CMV)

September 2, 2016 updated by: University Hospital, Limoges

Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients in the Prophylaxis Era, a French Multicentric Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80
        • Virologie
      • Angers, France, 49
        • Virologie
      • Besancon, France, 25
        • Virologie
      • Bobigny, France, 93
        • Virologie - Hôpital Avicenne
      • Bordeaux, France, 33
        • Virologie
      • Brest, France, 29
        • Virologie
      • Caen, France, 14
        • Virologie
      • Clermont Ferrand, France, 63
        • Virologie
      • Dijon, France, 21
        • Virologie
      • Fort de France, France, 97
        • Virologie
      • Grenoble, France, 38
        • Virologie
      • Lille, France, 59
        • Virologie
      • Limoges, France, 87042
        • Bactériologie Virologie
      • Lyon, France, 69
        • Virologie
      • Montpellier, France, 34
        • Virologie
      • Nancy, France, 54
        • Virologie
      • Nantes, France, 44
        • Virologie
      • Nimes, France, 30
        • Virologie
      • Paris, France, 75
        • 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
        • Virologie - Hôpital LARIBOISIERE
      • Poitiers, France, 86
        • Virologie
      • Reims, France, 51
        • Virologie
      • Rennes, France, 35
        • Virologie
      • Rouen, France, 76
        • Virologie
      • Saint-etienne, France, 42
        • Virologie
      • Strasbourg, France, 67
        • Virologie
      • Suresne, France, 92
        • Virologie
      • Toulouse, France, 31
        • Virologie
      • Tours, France, 37
        • Virologie
      • Villejuif, France, 94
        • Virologie - Hôpital Paul Brousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Resistance incidence in our patients with subgroup analysis, by organ and by the use of prophylaxis or preemptive treatment

Secondary Outcome Measures

Outcome Measure
Strain diversity in baseline isolates and in resistant isolates Frequency of known resistance mutations Identification of new resistance-related mutations.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Investigators

  • Principal Investigator: ALAIN Sophie, MD, University Hospital, Limoges

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 5, 2009

First Submitted That Met QC Criteria

November 5, 2009

First Posted (Estimate)

November 6, 2009

Study Record Updates

Last Update Posted (Estimate)

September 5, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • I06016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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