| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||||||
| Brief Title † | Surveillance Study of Viral Infections Following Lung Transplantation | ||||||||
| Official Title † | Season Surveillance Study of Viral Infections in Lung Transplant Recipients | ||||||||
| 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. |
||||||||
| 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 on EBV-DNA, CMV early antigen-testing and adenovirus-DNA by PCR. |
||||||||
| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Cohort, Prospective | ||||||||
| Primary Outcome Measure † | Incidence of bronchiolitis obliterans syndrome [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Incidence of acute rejection [ Time Frame: 1 year ] [ Designated as safety issue: No ] Incidence of hospitalisation [ Time Frame: 1 year ] [ Designated as safety issue: No ] Incidence of graft loss (death or re-do-transplantation) [ Time Frame: 2 year ] [ Designated as safety issue: No ] |
||||||||
| Condition † | Lung Transplantation Bronchiolitis Obliterans Epstein-Barr Virus Infections Paramyxoviridae Infections |
||||||||
| Intervention † | |||||||||
| MEDLINE PMIDs | 15130908, 15996256, 16510454 | ||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 388 | ||||||||
| Start Date † | October 2005 | ||||||||
| Completion Date | June 2008 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | Germany | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00701922 | ||||||||
| Organization ID | 4015 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Hannover Medical School | ||||||||
| Collaborators †† | Dpt. Pulmonology Dpt. Virology |
||||||||
| Investigators † |
|
||||||||
| Information Provided By | Hannover Medical School | ||||||||
| Verification Date | June 2008 | ||||||||
| First Received Date † | June 17, 2008 | ||||||||
| Last Updated Date | July 9, 2008 | ||||||||
|
