CytomegalovirusPHRC CMVNCT01008540
Prospective Multicentric Study of Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients
A study testing depistage in people with Cytomegalovirus, run by University Hospital, Limoges at 33 sites in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cytomegalovirus
- What is being tested?
- depistage
- How many people
- 800 participants
- Where
- 33 sitesFrance
- Study dates
- Aug 2006to Jun 2012
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- Patient without medical care.policy,
- patient that did not signed the médical consent
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
France33 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
Virologie
Dijon, 21
Virologie
Fort de France, 97
Virologie
Grenoble, 38
Virologie
Lille, 59
Bactériologie Virologie
Limoges, 87042
Virologie
Lyon, 69
Virologie
Montpellier, 34
Virologie
Nancy, 54
Virologie
Nantes, 44
Virologie
Nîmes, 30
Virologie - Hôpital BICHAT
Paris, 75
Virologie - Hôpital La Pitié Salpétrière
Paris, 75
Virologie - Hôpital LARIBOISIERE
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
Suresne, 92
Virologie
Toulouse, 31
Virologie
Tours, 37
Virologie - Hôpital Paul Brousse
Villejuif, 94
About this study
Official title: 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.
- Conditions
- Cytomegalovirus
- Being tested
- depistage
- Keywords
- cytomegalovirus, resistance, transplantation, Patient coming to an French transplantation center for solid organ or bone marrow transplant, with information and signed consent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
depistageBiological
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Resistance incidence in our patients with subgroup analysis, by organ and by the use of prophylaxis or preemptive treatment
Secondary outcomes (1)
Strain diversity in baseline isolates and in resistant isolates Frequency of known resistance mutations Identification of new resistance-related mutations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startAug 2006
- Primary completionDec 2010
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CytomegalovirusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ALAIN Sophie, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008540
- Sponsor's protocol ID
- I06016
- Acronym
- PHRC CMV
- Status last verified
- Jul 2025
- First submitted
- 5 Nov 2009
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andouard D, Mazeron MC, Ligat G, Couvreux A, Pouteil-Noble C, Cahen R, Yasdanpanah Y, Deering M, Viget N, Alain S, Hantz S. Contrasting effect of new HCMV pUL54 mutations on antiviral drug susceptibility: Benefits and limits of 3D analysis. Antiviral Res. 2016 May;129:115-119. doi: 10.1016/j.antiviral.2016.02.004. Epub 2016 Feb 10.
PubMed 26872863Germi R, Mariette C, Alain S, Lupo J, Thiebaut A, Brion JP, Epaulard O, Saint Raymond C, Malvezzi P, Morand P. Success and failure of artesunate treatment in five transplant recipients with disease caused by drug-resistant cytomegalovirus. Antiviral Res. 2014 Jan;101:57-61. doi: 10.1016/j.antiviral.2013.10.014. Epub 2013 Nov 1.
PubMed 24184983Hantz S, Garnier-Geoffroy F, Mazeron MC, Garrigue I, Merville P, Mengelle C, Rostaing L, Saint Marcoux F, Essig M, Rerolle JP, Cotin S, Germi R, Pillet S, Lebranchu Y, Turlure P, Alain S; French CMV Resistance Survey Study Group. Drug-resistant cytomegalovirus in transplant recipients: a French cohort study. J Antimicrob Chemother. 2010 Dec;65(12):2628-40. doi: 10.1093/jac/dkq368. Epub 2010 Oct 20.
PubMed 20961907
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients in the Prophylaxis Era, a French Multicentric Cohort Study
- ClinicalTrials.gov ID
- NCT01008540
- Acronym / sponsor ID
- PHRC CMV / I06016
- Conditions
- Cytomegalovirus
- Keywords
- cytomegalovirus, resistance, transplantation, Patient coming to an French transplantation center for solid organ or bone marrow transplant, with information and signed consent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 Nov 2009 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Patient without medical care.policy,
- patient that did not signed the médical consent
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 |
|---|---|---|
| depistageVirus 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 | Biological | – |
Primary outcome
Resistance incidence in our patients with subgroup analysis, by organ and by the use of prophylaxis or preemptive treatment
1 secondary outcome
Strain diversity in baseline isolates and in resistant isolates Frequency of known resistance mutations Identification of new resistance-related mutations.
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 20 Jul 2025.
- Results publication: PubMed 26872863Andouard D, Mazeron MC, Ligat G, Couvreux A, Pouteil-Noble C, Cahen R, Yasdanpanah Y, Deering M, Viget N, Alain S, Hantz S. Contrasting effect of new HCMV pUL54 mutations on antiviral drug susceptibility: Benefits and limits of 3D analysis. Antiviral Res. 2016 May;129:115-119. doi: 10.1016/j.antiviral.2016.02.004. Epub 2016 Feb 10.
- Derived from this study: PubMed 24184983Germi R, Mariette C, Alain S, Lupo J, Thiebaut A, Brion JP, Epaulard O, Saint Raymond C, Malvezzi P, Morand P. Success and failure of artesunate treatment in five transplant recipients with disease caused by drug-resistant cytomegalovirus. Antiviral Res. 2014 Jan;101:57-61. doi: 10.1016/j.antiviral.2013.10.014. Epub 2013 Nov 1.
- Derived from this study: PubMed 20961907Hantz S, Garnier-Geoffroy F, Mazeron MC, Garrigue I, Merville P, Mengelle C, Rostaing L, Saint Marcoux F, Essig M, Rerolle JP, Cotin S, Germi R, Pillet S, Lebranchu Y, Turlure P, Alain S; French CMV Resistance Survey Study Group. Drug-resistant cytomegalovirus in transplant recipients: a French cohort study. J Antimicrob Chemother. 2010 Dec;65(12):2628-40. doi: 10.1093/jac/dkq368. Epub 2010 Oct 20.
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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.
ALAIN Sophie, MD principal investigator
University Hospital, Limoges
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing depistage in people with Cytomegalovirus, run by University Hospital, Limoges at 33 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 1 inclusion and 2 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 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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?
Resistance incidence in our patients with subgroup analysis, by organ and by the use of prophylaxis or preemptive treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01008540, which also lists 3 linked publications.
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 20 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.