Prospective Multicentric Study of Cytomegalovirus Resistance in Transplant Patients and Bone Marr… (NCT01008540) | Clinical Trial Compass
CompletedNot Applicable
Prospective Multicentric Study of Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients
France800 participantsStarted 2006-08
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Resistance incidence in our patients with subgroup analysis, by organ and by the use of prophylaxis or preemptive treatment