Surveillance Study of Viral Infections Following Lung Transplantation
|ClinicalTrials.gov Identifier: NCT00701922|
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : October 28, 2011
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.
|Condition or disease|
|Lung Transplantation Bronchiolitis Obliterans Epstein-Barr Virus Infections Paramyxoviridae Infections|
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 Type :||Observational|
|Actual Enrollment :||388 participants|
|Official Title:||Season Surveillance Study of Viral Infections in Lung Transplant Recipients|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
- Incidence of bronchiolitis obliterans syndrome [ Time Frame: 1 year ]
- Incidence of acute rejection [ Time Frame: 1 year ]
- Incidence of hospitalisation [ Time Frame: 1 year ]
- Incidence of graft loss (death or re-do-transplantation) [ Time Frame: 2 year ]
Biospecimen Retention: Samples Without DNA
Nasopharyngeal and oropharyngeal swabs
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701922
|Hannover Medical School|
|Hannover, Germany, 30625|
|Principal Investigator:||Jens T Gottlieb, MD||Dpt. Pulmonary Medicine|
|Principal Investigator:||Ilka Engelmann, MD||Dpt. Virology, MHH|