Transplant Recipients With CMV InfectionORPHAVICNCT02067169
A French Cohort of Transplant Recipients With CMV Infection : Risk Factors for Antiviral Resistance in the Prophylaxis Era.
An observational study of Transplant Recipients With CMV Infection, run by University Hospital, Limoges at 38 sites in France.
Trial summary
Resistance to antivirals is a growing problem in transplantation.that may concerns up to 5% of patients treated for cytomegalovirus (CMV) syndrome or disease in recent per-protocol studies. This prevalence vary with the organ transplanted and the degree of viral replication and immunosuppression. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transplant Recipients With CMV Infection
- What is being tested?
- CMV Infection
- How many people
- 408 participants
- Where
- 38 sitesFrance
- Study dates
- Jan 2012to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: allograft recipient or hematopoietic stem cell or solid organ.
Who may be able to join
- allograft recipient with active CMV infection,
- or patient from the previous cohort, without opposition to biological collection of samples
Who cannot join
- not willing to participate, no health insurance
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
France38 sites
Virologie
Amiens, 80
Virologie
Angers, 49
Virologie
Besançon, 25
Virologie - Hôpital Avicenne
Bobigny, 93
Virologie
Bordeaux, 33
Virologie
Brest, 29
Virologie
Caen, 14
Virologie
Clermont-Ferrand, 63
AP-HP - Hôpital Beaujon - Virologie
Clichy, 92118
AP-HP - Hôpital MONDOR - Virologie
Créteil, 94010
Virologie
Dijon, 21
Virologie
Grenoble, 38
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350
Virologie
Lille, 59
Bactériologie Virologie
Limoges, 87042
HCLYON - Virologie - Hôpital La Croix Rousse
Lyon, 69314
Virologie
Lyon, 69
Virologie - AP-HM - La Timone
Marseille, 13385
Virologie
Montpellier, 34
Virologie
Nancy, 54
Virologie
Nantes, 44
Virologie
Nîmes, 30
AP-HP - Hôpital Saint-Antoine - Virologie
Paris, 75571
AP-HP - Hôpital Georges Pompidou - Virologie
Paris, 75908
AP-HP - Hôpital TENON - Virologie
Paris, 75970
Virologie - Hôpital BICHAT
Paris, 75
Virologie - Hôpital La Pitié Salpétrière
Paris, 75
Virologie - Hôpital NECKER
Paris, 75
Virologie - Hôpital SAINT-LOUIS
Paris, 75
Virologie
Poitiers, 86
Virologie
Reims, 51
Virologie
Rennes, 35
Virologie
Rouen, 76
Virologie
Saint-Etienne, 42
Virologie
Strasbourg, 67
Virologie
Toulouse, 31
Virologie
Tours, 37
Virologie - Hôpital Paul Brousse
Villejuif, 94
About this study
Official title: A French Cohort of Transplant Recipients With CMV Infection : Risk Factors for Antiviral Resistance in the Prophylaxis Era. Survey of Pharmacological and Virological Resistance of Cytomegalovirus to Antiviral Therapy in Transplantation.
Resistance to antivirals is a growing problem in transplantation.that may concerns up to 5% of patients treated for cytomegalovirus (CMV) syndrome or disease in recent per-protocol studies. This prevalence vary with the organ transplanted and the degree of viral replication and immunosuppression. Less data are available to date from real-life cohorts of patients, and there is no systematic survey of resistance in Europe or in the US. Non response to treatment concerns a larger group of patients and can result either from emergence of a resistant strain (virological resistance), from inadequate dosage of antivirals, or a high degree of immunosuppression, with a poor CMV immune response. The respective clinical impact of virological resistance and clinical resistance (of pharmacological or immunological origin) on graft outcome and long-term survival of patients has never been assessed. High viral loads and persistent replication associated to prolonged exposure to antivirals are known to favor the emergence of resistant strains. Though epidemiology of resistant strains, role of multiple infections, impact of various mutations on degree of resistance to antivirals and outcome remains to be further studied. Most studies are per-protocol studies or short-term studies conducted on limited populations. There are no data in real-life of transplanted patients at the era of enlarged prophylaxis except those from the French survey for cytomegalovirus resistance cohort opened at the end of 2006. From the first data collected on 346 patients we shown a 10,6% prevalence of non-response to therapy with 5,2% of virological resistance (6,1% incidence at one year on 214 patients) with a trend to poorer outcome in case of virological resistance and to the absence of impact of prophylaxis versus preemptive therapy, though larger populations and prolonged follow-up are requested to fulfill all objectives.
We therefore aim to constitute a prolonged survey cohort for CMV resistance with a large number of patients and a prolonged follow-up, to gather data on resistance to antivirals in real-life of transplant patients in an organized data bank, This cohort is in the continuum of our previous cohort started in 2006, granted by the Hospital Clinical Research Program Interregional (PHRC), with the same major objectives and prolonged follow-up of patients.
- Conditions
- Transplant Recipients With CMV Infection
- Being tested
- CMV Infection
- Keywords
- Transplantation, CMV infection, antiviral resistance
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV InfectionBiological
Routine follow-up (viral load, creatininaemia, neutrophil count, isolation of CMV strains when possible) and biological sample collection for . Resistance testing towards any antiviral available by genotype and phenotype (when an isolate is obtained) when resistance criteria are fulfilled. Plasma collection at treatment initiation, and in case of neutropenia, for antiviral dosage.
| Study group | Role | What they receive |
|---|---|---|
| CMV infection | allograft recipient with active CMV infection Receives: Biological: CMV Infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence and incidence of resistance of cytomegalovirus
Non response to therapy is defined as persistent viral replication after more than 3 weeks of appropriate antiviral treatment, with or without clinical manifestations.
Measured: 3 weeks
Secondary outcomes (1)
pharmacological and virological resistance
Measure the respective incidence of pharmacological and virological resistance
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startJan 2012
- Primary completionMay 2016
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant Recipients With CMV InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie ALAIN, MD, Principal investigator, Limoges UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067169
- Sponsor's protocol ID
- I09013 ORPHAVIC
- Acronym
- ORPHAVIC
- Status last verified
- Oct 2019
- First submitted
- 14 Feb 2014
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A French Cohort of Transplant Recipients With CMV Infection : Risk Factors for Antiviral Resistance in the Prophylaxis Era. Survey of Pharmacological and Virological Resistance of Cytomegalovirus to Antiviral Therapy in Transplantation.
- ClinicalTrials.gov ID
- NCT02067169
- Acronym / sponsor ID
- ORPHAVIC / I09013 ORPHAVIC
- Conditions
- Transplant Recipients With CMV Infection
- Keywords
- Transplantation, CMV infection, antiviral resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Resistance to antivirals is a growing problem in transplantation.that may concerns up to 5% of patients treated for cytomegalovirus (CMV) syndrome or disease in recent per-protocol studies. This prevalence vary with the organ transplanted and the degree of viral replication and immunosuppression. Less data are available to date from real-life cohorts of patients, and there is no systematic survey of resistance in Europe or in the US. Non response to treatment concerns a larger group of patients and can result either from emergence of a resistant strain (virological resistance), from inadequate dosage of antivirals, or a high degree of immunosuppression, with a poor CMV immune response. The respective clinical impact of virological resistance and clinical resistance (of pharmacological or immunological origin) on graft outcome and long-term survival of patients has never been assessed. High viral loads and persistent replication associated to prolonged exposure to antivirals are known to favor the emergence of resistant strains. Though epidemiology of resistant strains, role of multiple infections, impact of various mutations on degree of resistance to antivirals and outcome remains to be further studied. Most studies are per-protocol studies or short-term studies conducted on limited populations. There are no data in real-life of transplanted patients at the era of enlarged prophylaxis except those from the French survey for cytomegalovirus resistance cohort opened at the end of 2006. From the first data collected on 346 patients we shown a 10,6% prevalence of non-response to therapy with 5,2% of virological resistance (6,1% incidence at one year on 214 patients) with a trend to poorer outcome in case of virological resistance and to the absence of impact of prophylaxis versus preemptive therapy, though larger populations and prolonged follow-up are requested to fulfill all objectives.
We therefore aim to constitute a prolonged survey cohort for CMV resistance with a large number of patients and a prolonged follow-up, to gather data on resistance to antivirals in real-life of transplant patients in an organized data bank, This cohort is in the continuum of our previous cohort started in 2006, granted by the Hospital Clinical Research Program Interregional (PHRC), with the same major objectives and prolonged follow-up of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMV infection | – | Biological: CMV Infectionallograft recipient with active CMV infection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- allograft recipient or hematopoietic stem cell or solid organ.
Key inclusion criteria (2 listed)
- allograft recipient with active CMV infection,
- or patient from the previous cohort, without opposition to biological collection of samples
Key exclusion criteria (1 listed)
- not willing to participate, no health insurance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMV InfectionRoutine follow-up (viral load, creatininaemia, neutrophil count, isolation of CMV strains when possible) and biological sample collection for . Resistance testing towards any antiviral available by genotype and phenotype (when an isolate is obtained) when resistance criteria are fulfilled. Plasma collection at treatment initiation, and in case of neutropenia, for antiviral dosage. | Biological | CMV infection |
Primary outcome
prevalence and incidence of resistance of cytomegalovirus
Time frame: 3 weeks
Non response to therapy is defined as persistent viral replication after more than 3 weeks of appropriate antiviral treatment, with or without clinical manifestations.
1 secondary outcome
pharmacological and virological resistance
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
Related trials for Transplant Recipients With CMV Infection
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Cytomegalovirus (CMV) Infection, Kidney Transplant Recipient
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie ALAIN, MD principal investigator
Limoges UH
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant Recipients With CMV Infection, run by University Hospital, Limoges at 38 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence and incidence of resistance of cytomegalovirus (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019.