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

Cytomegalovirus Clinical Trial

— PHRC CMV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008540
• Other study ID #: I06016
• Status: Completed
• Phase: N/A
• First received: November 5, 2009
• Last updated: September 2, 2016
• Start date: August 2006
• Est. completion date: June 2012

Study information

• Verified date: September 2016
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: June 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cytomegalovirus

Intervention

Biological:
• 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

Locations

Country	Name	City	State
France	Virologie	Amiens
France	Virologie	Angers
France	Virologie	Besancon
France	Virologie - Hôpital Avicenne	Bobigny
France	Virologie	Bordeaux
France	Virologie	Brest
France	Virologie	Caen
France	Virologie	Clermont Ferrand
France	Virologie	Dijon
France	Virologie	Fort de France
France	Virologie	Grenoble
France	Virologie	Lille
France	Bactériologie Virologie	Limoges
France	Virologie	Lyon
France	Virologie	Montpellier
France	Virologie	Nancy
France	Virologie	Nantes
France	Virologie	Nimes
France	Virologie - Hôpital BICHAT	Paris
France	Virologie - Hôpital La Pitié Salpétrière	Paris
France	Virologie - Hôpital LARIBOISIERE	Paris
France	Virologie - Hôpital NECKER	Paris
France	Virologie - Hôpital SAINT-LOUIS	Paris
France	Virologie	Poitiers
France	Virologie	Reims
France	Virologie	Rennes
France	Virologie	Rouen
France	Virologie	Saint-etienne
France	Virologie	Strasbourg
France	Virologie	Suresne
France	Virologie	Toulouse
France	Virologie	Tours
France	Virologie - Hôpital Paul Brousse	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resistance incidence in our patients with subgroup analysis, by organ and by the use of prophylaxis or preemptive treatment			No
Secondary	Strain diversity in baseline isolates and in resistant isolates Frequency of known resistance mutations Identification of new resistance-related mutations.			No