NCT00701922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
388

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
Last Updated

October 28, 2011

Status Verified

December 1, 2008

Enrollment Period

2.2 years

First QC Date

June 17, 2008

Last Update Submit

October 27, 2011

Conditions

Lung TransplantationBronchiolitis ObliteransEpstein-Barr Virus InfectionsParamyxoviridae Infections

Keywords

lung transplantationBronchiolitis ObliteransEpstein-Barr Virus InfectionsParamyxoviridae InfectionsHerpesviridae

Outcome Measures

Primary Outcomes (1)

  • Incidence of bronchiolitis obliterans syndrome

    1 year

Secondary Outcomes (3)

  • Incidence of acute rejection

    1 year

  • Incidence of hospitalisation

    1 year

  • Incidence of graft loss (death or re-do-transplantation)

    2 year

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

lung transplant recipients in in a single-centre outpatient clinic

You may qualify if:

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

You may not qualify if:

  • refused consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

Related Publications (4)

  • 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.

    PMID: 15130908BACKGROUND

  • 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.

    PMID: 15996256BACKGROUND

  • 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.

    PMID: 16510454BACKGROUND

  • 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.

    PMID: 19303808DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal and oropharyngeal swabs bronchoalveolar lavage blood samples

MeSH Terms

Conditions

Bronchiolitis ObliteransEpstein-Barr Virus InfectionsParamyxoviridae Infections

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsMononegavirales InfectionsRNA Virus Infections

Study Officials

  • Jens T Gottlieb, MD

    Dpt. Pulmonary Medicine

    PRINCIPAL INVESTIGATOR

  • Ilka Engelmann, MD

    Dpt. Virology, MHH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 19, 2008

Study Start

October 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

October 28, 2011

Record last verified: 2008-12

Locations

DE(1)