Season Surveillance Study of Viral Infections in Lung Transplant Recipients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hannover Medical School
- Enrollment
- 388
- Locations
- 1
- Primary Endpoint
- Incidence of bronchiolitis obliterans syndrome
Study Overview
Brief Summary
The present study was conducted to study the impact community acquired respiratory virus (CARV) infections in an outpatient setting on graft function of lung transplant recipients. The study was aimed to identify risk factors for CARV infections.
The study was further intended to investigate an association of Epstein-Barr virus (EBV), cytomegalovirus (CMV) and human adenovirus (HAdV) with the development of BOS and to identify risk factors for virus detection in blood.
Detailed Description
Informed consent was obtained from the LTx recipients and the study was approved of by the institutional review board of Hannover medical school.
LTx recipients are screened for CARV infections during the cold season (end October until end April) in a single-centre outpatient clinic. Symptoms of upper (URTI) and lower respiratory tract infections (URTI) are recorded by questionnaires and findings.
Nasopharyngeal and oropharyngeal swabs (NOS) were performed to detect RV-antigens by immunofluorescence testing (IFT) of respiratory-syncytial virus (RSV), adenovirus, parainfluenza (PIV), influenza and cultures for CARV are performed. BAL was performed when clinically indicated and processed by IFT. Multiplex-PCR to detect 14 CARV are processed in symptomatic patients.
In addition blood samples are monitored at each contact to investigate an association of Epstein-Barr virus (EBV), cytomegalovirus (CMV) and human adenovirus (HAdV) with the development of BOS and to identify risk factors for virus detection in blood.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adults 18-70 years
- •lung transplantation (including single, double, combination and re-do transplants)
Exclusion Criteria
- •refused consent
Outcomes
Primary Outcomes
Incidence of bronchiolitis obliterans syndrome
Time Frame: 1 year
Secondary Outcomes
- Incidence of graft loss (death or re-do-transplantation)(2 year)
- Incidence of acute rejection(1 year)
- Incidence of hospitalisation(1 year)