Surveillance Study of Viral Infections Following Lung Transplantation

This study has been completed.
Sponsor:
Collaborators:
Department of Pulmonology
Department of Virology
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00701922
First received: June 17, 2008
Last updated: October 27, 2011
Last verified: December 2008
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Season Surveillance Study of Viral Infections in Lung Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Incidence of bronchiolitis obliterans syndrome [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of acute rejection [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Incidence of hospitalisation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Incidence of graft loss (death or re-do-transplantation) [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Nasopharyngeal and oropharyngeal swabs

bronchoalveolar lavage

blood samples


Enrollment: 388
Study Start Date: October 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

lung transplant recipients in in a single-centre outpatient clinic

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • refused consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701922

Locations
Germany
Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Department of Pulmonology
Department of Virology
Investigators
Principal Investigator: Jens T Gottlieb, MD Dpt. Pulmonary Medicine
Principal Investigator: Ilka Engelmann, MD Dpt. Virology, MHH
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT00701922     History of Changes
Other Study ID Numbers: 4015
Study First Received: June 17, 2008
Last Updated: October 27, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Hannover Medical School:
lung transplantation
Bronchiolitis Obliterans
Epstein-Barr Virus Infections
Paramyxoviridae Infections
Herpesviridae

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Communicable Diseases
Epstein-Barr Virus Infections
Infection
Paramyxoviridae Infections
Respirovirus Infections
Virus Diseases
Bronchial Diseases
Bronchitis
DNA Virus Infections
Herpesviridae Infections
Lung Diseases
Lung Diseases, Obstructive
Mononegavirales Infections
Neoplasms
Neoplasms, Experimental
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Tumor Virus Infections

ClinicalTrials.gov processed this record on October 20, 2014