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Clinical Trials/NCT00701922
NCT00701922
Completed
Not Applicable

Season Surveillance Study of Viral Infections in Lung Transplant Recipients

Hannover Medical School1 site in 1 country388 target enrollmentOctober 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Transplantation
Sponsor
Hannover Medical School
Enrollment
388
Locations
1
Primary Endpoint
Incidence of bronchiolitis obliterans syndrome
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
December 2007
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • refused consent

Outcomes

Primary Outcomes

Incidence of bronchiolitis obliterans syndrome

Time Frame: 1 year

Secondary Outcomes

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

Study Sites (1)

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