Lung TransplantationNCT00701922
Surveillance Study of Viral Infections Following Lung Transplantation
An observational study of Lung Transplantation and Bronchiolitis Obliterans, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Transplantation, Bronchiolitis Obliterans, Epstein-Barr Virus Infections
- How many people
- 388 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2005to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: lung transplant recipients in in a single-centre outpatient clinic
Who may be able to join
- adults 18-70 years
- lung transplantation (including single, double, combination and re-do transplants)
Who cannot join
- refused consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Season Surveillance Study of Viral Infections in Lung Transplant Recipients
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.
Read the 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.
- Conditions
- Lung Transplantation, Bronchiolitis Obliterans, Epstein-Barr Virus Infections, Paramyxoviridae Infections
- Keywords
- lung transplantation, Bronchiolitis Obliterans, Epstein-Barr Virus Infections, Paramyxoviridae Infections, Herpesviridae
- Medical subject headings
- Bronchiolitis Obliterans, Epstein-Barr Virus Infections, Paramyxoviridae Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bronchiolitis obliterans syndrome
Measured: 1 year
Secondary outcomes (3)
Incidence of acute rejection
Measured: 1 year
Incidence of hospitalisation
Measured: 1 year
Incidence of graft loss (death or re-do-transplantation)
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startOct 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Pulmonology, Department of Virology
- Investigators
- Jens T Gottlieb, MD, Principal investigator, Dpt. Pulmonary MedicineIlka Engelmann, MD, Principal investigator, Dpt. Virology, MHH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701922
- Sponsor's protocol ID
- 4015
- Status last verified
- Dec 2008
- First submitted
- 17 Jun 2008
- Last updated
- 28 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1164/rccm.200310-1359OC. Epub 2004 May 6.
PubMed 15130908Kumar 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.
PubMed 15996256Milstone 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.
PubMed 16510454Engelmann 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.
PubMed 19303808
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Season Surveillance Study of Viral Infections in Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT00701922
- Acronym / sponsor ID
- 4015
- Conditions
- Lung Transplantation, Bronchiolitis Obliterans, Epstein-Barr Virus Infections, Paramyxoviridae Infections
- Keywords
- lung transplantation, Bronchiolitis Obliterans, Epstein-Barr Virus Infections, Paramyxoviridae Infections, Herpesviridae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Department of Pulmonology, Department of Virology
- Study start
- Oct 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- lung transplant recipients in in a single-centre outpatient clinic
Key inclusion criteria (2 listed)
- adults 18-70 years
- lung transplantation (including single, double, combination and re-do transplants)
Key exclusion criteria (1 listed)
- refused consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of bronchiolitis obliterans syndrome
Time frame: 1 year
3 secondary outcomes
Incidence of acute rejection
Time frame: 1 year
Incidence of hospitalisation
Time frame: 1 year
Incidence of graft loss (death or re-do-transplantation)
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2011.
- Background: PubMed 15130908Khalifah 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.
- Background: PubMed 15996256Kumar 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.
- Background: PubMed 16510454Milstone 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.
- Derived from this study: PubMed 19303808Engelmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens T Gottlieb, MD principal investigator
Dpt. Pulmonary Medicine
Ilka Engelmann, MD principal investigator
Dpt. Virology, MHH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplantation and Bronchiolitis Obliterans, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bronchiolitis obliterans syndrome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00701922, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2011.