Clinical Trial: Surveillance Study of Viral Infections Following Lung Transplantation

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Season Surveillance Study of Viral Infections in Lung Transplant Recipients

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 Summary:

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.


Sponsor: Hannover Medical School

Current Primary Outcome: Incidence of bronchiolitis obliterans syndrome [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Hannover Medical School

Dates:
Date Received: June 17, 2008
Date Started: October 2005
Date Completion:
Last Updated: October 27, 2011
Last Verified: December 2008