Surveillance Study of Viral Infections Following Lung Transplantation
Study Details
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 | Intervention/Treatment | Phase |
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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
Outcome Measures
Primary Outcome Measures
- Incidence of bronchiolitis obliterans syndrome [1 year]
Secondary Outcome Measures
- Incidence of acute rejection [1 year]
- Incidence of hospitalisation [1 year]
- Incidence of graft loss (death or re-do-transplantation) [2 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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adults 18-70 years
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lung transplantation (including single, double, combination and re-do transplants)
Exclusion Criteria:
- refused consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.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.
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