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NCT00701922 Clinical Trial

Surveillance Study of Viral Infections Following Lung Transplantation

Lung Transplantation Clinical Trial

Official title:
Season Surveillance Study of Viral Infections in Lung Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00701922
Other study ID # 4015
Secondary ID
Status Completed
Phase N/A
First received June 17, 2008
Last updated October 27, 2011
Start date October 2005
Est. completion date December 2007

Study information
Verified date December 2008
Source Hannover Medical School
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 388
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- adults 18-70 years

- lung transplantation (including single, double, combination and re-do transplants)

Exclusion Criteria:

- refused consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Hannover Medical School Hannover

Sponsors (3)
Lead Sponsor Collaborator
Hannover Medical School Department of Pulmonology, Department of Virology

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of bronchiolitis obliterans syndrome 1 year No
Secondary Incidence of acute rejection 1 year No
Secondary Incidence of hospitalisation 1 year No
Secondary Incidence of graft loss (death or re-do-transplantation) 2 year No
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