Lung Transplant; ComplicationsNCT04377139
Management of Cytomegalovirus (CMV) Infection in Lung Transplant Recipients (LTR)
An observational study of Lung Transplant; Complications, run by Hospital Universitari Vall d'Hebron Research Institute.
Trial summary
Background: Lung transplant recipients (LTR) have the highest risk of CMV infection. CMV pneumonitis, lymphocytic bronchitis, and detection of CMV DNA in bronchoalveolar lavage fluid are independent risk factors for the development of chronic lung allograft dysfunction (CLAD). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lung Transplant; Complications
- What is being tested?
- Prophylaxis and Preemptive
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Jun 2022
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All those LTR performed in Spain during the study period
Who may be able to join
- Survival > 1 month post-transplant
- High to moderate risk patients to develop CMV disease by means of pre-transplant CMV serology:
- Donor positive to recipient negative
- Recipient positive independently of donor serology
Who cannot join
- Survival < 1 month after procedure
- Low risk serology to develop CMV disease: both donor and recipient seronegative
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Observational, Epidemiological, Retrospective Study of the Management of CMV Infection in a Cohort of Patients Receiving Lung Transplantation in Spain
Background: Lung transplant recipients (LTR) have the highest risk of CMV infection. CMV pneumonitis, lymphocytic bronchitis, and detection of CMV DNA in bronchoalveolar lavage fluid are independent risk factors for the development of chronic lung allograft dysfunction (CLAD). However, to demonstrate the clinical impact of the indirect effects of CMV, it is necessary to conduct studies with a very large sample size.
Hypothesis: The different current preventive strategies for CMV infection in LTR and their clinical application on a daily basis impact on the development of direct and indirect effects of CMV in this population.
Read more
Objectives: To study the effect of CMV infection on LTR in relation to current preventive strategies in terms of:
- The incidence of acute and chronic rejection
- The incidence of other opportunistic infections
- The incidence of neoplastic disease, especially, post-transplant lymphoproliferative disease
- Patient and graft survival Methods: Multicenter, retrospective, cohort study. Consecutive inclusion of all adult lung transplant recipients from 2013 to 2017 with 2 years of follow-up. The investigators will collect and analyze the main clinical and microbiological variables in order to respond to the objectives of the study.
Relevance: Knowing in detail the current epidemiology of CMV infection in LTR and its subsequent influence on both mortality and the presence of different complications, could allow improving the management of these patients in the future.
- Conditions
- Lung Transplant; Complications
- Being tested
- Prophylaxis, Preemptive
- Keywords
- cytomegalovirus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProphylaxisProcedure or surgery
The intervention consists of analyzing the differences in the evolution of lung transplant recipients in relation to the intervention of prophylaxis or preemptive therapy against CMV in LTR
PreemptiveProcedure or surgery
The intervention consists of analyzing the differences in the evolution of lung transplant recipients in relation to the intervention of prophylaxis or preemptive therapy against CMV in LTR
| Study group | Role | What they receive |
|---|---|---|
| Prophylaxis | Those LTR receiving prophylaxis against CMV Receives: Procedure: Prophylaxis | |
| Preemptive therapy | Those LTR receiving preemptive therapy against CMV Receives: Procedure: Preemptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV infection and/or disease
Incidence
Measured: Two-year follow-up
Secondary outcomes (1)
Graft rejection both acute or CLAD
Incidence
Measured: Two-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study startJun 2020 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377139
- Sponsor's protocol ID
- PR(AG)54/2020
- Status last verified
- May 2020
- First submitted
- 3 May 2020
- Last updated
- 11 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Epidemiological, Retrospective Study of the Management of CMV Infection in a Cohort of Patients Receiving Lung Transplantation in Spain
- ClinicalTrials.gov ID
- NCT04377139
- Acronym / sponsor ID
- PR(AG)54/2020
- Conditions
- Lung Transplant; Complications
- Keywords
- cytomegalovirus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 6 May 2020 (actual)
- 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.
Background: Lung transplant recipients (LTR) have the highest risk of CMV infection. CMV pneumonitis, lymphocytic bronchitis, and detection of CMV DNA in bronchoalveolar lavage fluid are independent risk factors for the development of chronic lung allograft dysfunction (CLAD). However, to demonstrate the clinical impact of the indirect effects of CMV, it is necessary to conduct studies with a very large sample size.
Hypothesis: The different current preventive strategies for CMV infection in LTR and their clinical application on a daily basis impact on the development of direct and indirect effects of CMV in this population.
Objectives: To study the effect of CMV infection on LTR in relation to current preventive strategies in terms of:
- The incidence of acute and chronic rejection
- The incidence of other opportunistic infections
- The incidence of neoplastic disease, especially, post-transplant lymphoproliferative disease
- Patient and graft survival Methods: Multicenter, retrospective, cohort study. Consecutive inclusion of all adult lung transplant recipients from 2013 to 2017 with 2 years of follow-up. The investigators will collect and analyze the main clinical and microbiological variables in order to respond to the objectives of the study.
Relevance: Knowing in detail the current epidemiology of CMV infection in LTR and its subsequent influence on both mortality and the presence of different complications, could allow improving the management of these patients in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylaxis | – | Procedure: ProphylaxisThose LTR receiving prophylaxis against CMV |
| Preemptive therapy | – | Procedure: PreemptiveThose LTR receiving preemptive therapy against CMV |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All those LTR performed in Spain during the study period
Key inclusion criteria (4 listed)
- Survival > 1 month post-transplant
- High to moderate risk patients to develop CMV disease by means of pre-transplant CMV serology:
- Donor positive to recipient negative
- Recipient positive independently of donor serology
Key exclusion criteria (2 listed)
- Survival < 1 month after procedure
- Low risk serology to develop CMV disease: both donor and recipient seronegative
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 |
|---|---|---|
| ProphylaxisThe intervention consists of analyzing the differences in the evolution of lung transplant recipients in relation to the intervention of prophylaxis or preemptive therapy against CMV in LTR | Procedure or surgery | Prophylaxis |
| PreemptiveThe intervention consists of analyzing the differences in the evolution of lung transplant recipients in relation to the intervention of prophylaxis or preemptive therapy against CMV in LTR | Procedure or surgery | Preemptive therapy |
Primary outcome
CMV infection and/or disease
Time frame: Two-year follow-up
Incidence
1 secondary outcome
Graft rejection both acute or CLAD
Time frame: Two-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant; Complications, run by Hospital Universitari Vall d'Hebron Research Institute.
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 4 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: status not confirmed, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oscar Len, MD (+34934896090, oscar.len@vhir.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV infection and/or disease (time frame: Two-year follow-up). 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 11 May 2020.