Surveillance Study of Viral Infections Following Lung Transplantation

Completed

• Conditions: Epstein-Barr Virus Infections; Paramyxoviridae Infections; Lung Transplantation; Bronchiolitis Obliterans

• Registration Number: NCT00701922
• Lead Sponsor: Hannover Medical School

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 Timeline

• Study Start: 2005-10
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Status Verified: 2008-12
• Last Update Submitted: 2011-10-27
• Last Update Posted: 2011-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 388

Inclusion Criteria

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

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Exclusion Criteria

• refused consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of bronchiolitis obliterans syndrome	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Germany