Lung Transplantation Clinical Trial
Official title:
Season Surveillance Study of Viral Infections in Lung Transplant Recipients
Verified date | December 2008 |
Source | Hannover Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Hannover Medical School | Hannover |
Lead Sponsor | Collaborator |
---|---|
Hannover Medical School | Department of Pulmonology, Department of Virology |
Germany,
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
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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