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NCT Number: NCT00701922

Surveillance Study of Viral Infections Following Lung Transplantation

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.

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Key information

Conditions

Lung Transplantation Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchitis DNA Virus Infections Epstein-Barr Virus Infections Herpesviridae Infections Infections Lung Diseases Lung Diseases, Obstructive Mononegavirales Infections Paramyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Tumor Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hannover Medical School

Hanover, 30625, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • refused consent

Treatment and study plan

Primary outcomes

  1. Incidence of bronchiolitis obliterans syndrome

    Time frame: 1 year

Secondary outcomes

  1. Incidence of acute rejection

    Time frame: 1 year

  2. Incidence of hospitalisation

    Time frame: 1 year

  3. Incidence of graft loss (death or re-do-transplantation)

    Time frame: 2 year

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Collaborators

  • Department of Pulmonology
  • Department of Virology

Registry information

Official study title

Season Surveillance Study of Viral Infections in Lung Transplant Recipients

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jun 19, 2008
Registry last updated
Oct 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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