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Surveillance Study of Viral Infections Following Lung Transplantation

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ClinicalTrials.gov Identifier: NCT00701922
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : October 28, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
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.


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

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 Design

Study Type : Observational
Actual Enrollment : 388 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Season Surveillance Study of Viral Infections in Lung Transplant Recipients
Study Start Date : October 2005
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Incidence of bronchiolitis obliterans syndrome [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA

Nasopharyngeal and oropharyngeal swabs

bronchoalveolar lavage

blood samples


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: October 28, 2011
Last Verified: December 2008

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

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