Surveillance Study of Viral Infections Following Lung Transplantation - Full Text View

Sponsor:	Hannover Medical School
Collaborators:	Dpt. Pulmonology Dpt. Virology
Information provided by:	Hannover Medical School
ClinicalTrials.gov Identifier:	NCT00701922

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:	Cohort, Prospective
Official Title:	Season Surveillance Study of Viral Infections in Lung Transplant Recipients

Resource links provided by NLM:

MedlinePlus related topics: Lung Transplantation

U.S. FDA Resources

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

Biospecimen Description:

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

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

Dpt. Pulmonology

Dpt. Virology

Investigators

Principal Investigator:	Jens T Gottlieb, MD	Dpt. Pulmonary Medicine
Principal Investigator:	Ilka Engelmann, MD	Dpt. Virology, MHH

More Information

Publications:

Khalifah AP, Hachem RR, Chakinala MM, Schechtman KB, Patterson GA, Schuster DP, Mohanakumar T, Trulock EP, Walter MJ. Respiratory viral infections are a distinct risk for bronchiolitis obliterans syndrome and death. Am J Respir Crit Care Med. 2004 Jul 15;170(2):181-7. Epub 2004 May 6.

Kumar D, Erdman D, Keshavjee S, Peret T, Tellier R, Hadjiliadis D, Johnson G, Ayers M, Siegal D, Humar A. Clinical impact of community-acquired respiratory viruses on bronchiolitis obliterans after lung transplant. Am J Transplant. 2005 Aug;5(8):2031-6.

Milstone AP, Brumble LM, Barnes J, Estes W, Loyd JE, Pierson RN 3rd, Dummer S. A single-season prospective study of respiratory viral infections in lung transplant recipients. Eur Respir J. 2006 Jul;28(1):131-7. Epub 2006 Mar 1.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Engelmann I, Welte T, Fühner T, Simon AR, Mattner F, Hoy L, Schulz TF, Gottlieb J. Detection of Epstein-Barr virus DNA in peripheral blood is associated with the development of bronchiolitis obliterans syndrome after lung transplantation. J Clin Virol. 2009 May;45(1):47-53. Epub 2009 Mar 20.

Responsible Party:	Hannover Medical School ( Hannover Medical School )
Study ID Numbers:	4015
Study First Received:	June 17, 2008
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00701922 History of Changes
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:

Communicable Diseases
RNA Virus Infections
Lung Diseases, Interstitial
Paramyxoviridae Infections
Bronchial Diseases
Bronchiolitis
Tumor Virus Infections
Infection
Bronchiolitis Obliterans
Neoplasms, Experimental
Herpesviridae Infections

Virus Diseases
Neoplasms
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
DNA Virus Infections
Epstein-Barr Virus Infections
Bronchitis
Mononegavirales Infections

ClinicalTrials.gov processed this record on November 27, 2009