Clinical trial NCT00701922: Surveillance Study of Viral Infections Following Lung Transplantation
Official title: Season Surveillance Study of Viral Infections in Lung Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplantation
Bronchiolitis Obliterans
Epstein-Barr Virus Infections
Paramyxoviridae Infections
Keywords: lung transplantation
Bronchiolitis Obliterans
Epstein-Barr Virus Infections
Paramyxoviridae Infections
Herpesviridae
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Department of Pulmonology
name: Department of Virology
First posted: 2008-06-19
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lung transplant recipients in in a single-centre outpatient clinic

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.

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 criteria: Inclusion Criteria:

* adults 18-70 years
* lung transplantation (including single, double, combination and re-do transplants)

Exclusion Criteria:

* refused consent

Primary outcomes:
measure: Incidence of bronchiolitis obliterans syndrome
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of acute rejection
timeFrame: 1 year
measure: Incidence of hospitalisation
timeFrame: 1 year
measure: Incidence of graft loss (death or re-do-transplantation)
timeFrame: 2 year
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Dpt. Pulmonary Medicine
name: Jens T Gottlieb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dpt. Virology, MHH
name: Ilka Engelmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1164/rccm.200310-1359OC. Epub 2004 May 6.
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. doi: 10.1111/j.1600-6143.2005.00971.x.
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. doi: 10.1183/09031936.06.00105505. Epub 2006 Mar 1.
citation: Engelmann I, Welte T, Fuhner 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. doi: 10.1016/j.jcv.2009.02.005. Epub 2009 Mar 20.