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

Not Applicable

Completed

• Conditions: Cytomegalovirus

• Registration Number: NCT01008540
• Lead Sponsor: University Hospital, Limoges

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-05
• Study First Posted: 2009-11-06
• Primary Completion: 2010-12
• Study Completion: 2012-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Resistance incidence in our patients with subgroup analysis, by organ and by the use of prophylaxis or preemptive treatment

Secondary Outcome Measures

Name	Time	Method
Strain diversity in baseline isolates and in resistant isolates Frequency of known resistance mutations Identification of new resistance-related mutations.

Trial Locations

Locations (9)

Virologie; 🇫🇷 Tours, France

Virologie - Hôpital Avicenne; 🇫🇷 Bobigny, France

Bactériologie Virologie; 🇫🇷 Limoges, 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 - Hôpital Paul Brousse; 🇫🇷 Villejuif, France