Surveillance Study of Viral Infections Following Lung Transplantation

Season Surveillance Study of Viral Infections in Lung Transplant Recipients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00701922

Enrollment

388

Registered

2008-06-19

Start date

2005-10-31

Completion date

2007-12-31

Last updated

2011-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis Obliterans, Epstein-Barr Virus Infections, Lung Transplantation, Paramyxoviridae Infections

Keywords

lung transplantation, Bronchiolitis Obliterans, Epstein-Barr Virus Infections, Paramyxoviridae Infections, Herpesviridae

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* adults 18-70 years * lung transplantation (including single, double, combination and re-do transplants)

Exclusion criteria

* refused consent

Design outcomes

Primary

Measure	Time frame
Incidence of bronchiolitis obliterans syndrome	1 year

Secondary

Measure	Time frame
Incidence of acute rejection	1 year
Incidence of hospitalisation	1 year
Incidence of graft loss (death or re-do-transplantation)	2 year

Countries

Germany

Outcome results