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Surveillance Study of Viral Infections Following Lung Transplantation

NCT ID: NCT00701922

Last Updated: 2011-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

388 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Lung Transplantation Bronchiolitis Obliterans Epstein-Barr Virus Infections Paramyxoviridae Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* refused consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Pulmonology

UNKNOWN

Sponsor Role collaborator

Department of Virology

AMBIG

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Hannover Medical School

Principal Investigators

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Jens T Gottlieb, MD

Role: PRINCIPAL_INVESTIGATOR

Dpt. Pulmonary Medicine

Ilka Engelmann, MD

Role: PRINCIPAL_INVESTIGATOR

Dpt. Virology, MHH

Locations

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Hannover Medical School

Hanover, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 15130908 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15996256 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16510454 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19303808 (View on PubMed)

Other Identifiers

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4015

Identifier Type: -

Identifier Source: org_study_id