Transplant Recipients With CMV Infection Clinical Trial
— ORPHAVICOfficial 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.
| NCT number | NCT02067169 |
| Other study ID # | I09013 ORPHAVIC |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2012 |
| Est. completion date | May 2018 |
| Verified date | October 2019 |
| Source | University Hospital, Limoges |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 408 |
| Est. completion date | May 2018 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - allograft recipient with active CMV infection, - or patient from the previous cohort, without opposition to biological collection of samples Exclusion Criteria: - not willing to participate, no health insurance |
| 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 | AP-HP - Hôpital Beaujon - Virologie | Clichy | |
| France | AP-HP - Hôpital MONDOR - Virologie | Creteil | |
| France | Virologie | Dijon | |
| France | Virologie | Grenoble | |
| France | Centre Chirurgical Marie Lannelongue | Le Plessis Robinson | |
| France | Virologie | Lille | |
| France | Bactériologie Virologie | Limoges | |
| France | HCLYON - Virologie - Hôpital La Croix Rousse | Lyon | |
| France | Virologie | Lyon | |
| France | Virologie - AP-HM - La Timone | Marseille | |
| France | Virologie | Montpellier | |
| France | Virologie | Nancy | |
| France | Virologie | Nantes | |
| France | Virologie | Nimes | |
| France | AP-HP - Hôpital Georges Pompidou - Virologie | Paris | |
| France | AP-HP - Hôpital Saint-Antoine - Virologie | Paris | |
| France | AP-HP - Hôpital TENON - Virologie | Paris | |
| France | Virologie - Hôpital BICHAT | Paris | |
| France | Virologie - Hôpital La Pitié Salpétrière | 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 | Toulouse | |
| France | Virologie | Tours | |
| France | Virologie - Hôpital Paul Brousse | Villejuif |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Limoges |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 3 weeks | |
| Secondary | pharmacological and virological resistance | Measure the respective incidence of pharmacological and virological resistance | 2 years |