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| Tracking Information | |||||||||
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| First Received Date ICMJE | June 17, 2008 | ||||||||
| Last Updated Date | December 31, 2008 | ||||||||
| Start Date ICMJE | October 2005 | ||||||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Incidence of bronchiolitis obliterans syndrome [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00701922 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Surveillance Study of Viral Infections Following Lung Transplantation | ||||||||
| Official Title ICMJE | 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. 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Cohort, Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 388 | ||||||||
| Completion Date | December 2007 | ||||||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00701922 | ||||||||
| Responsible Party | Hannover Medical School, Hannover Medical School | ||||||||
| Study ID Numbers ICMJE | 4015 | ||||||||
| Study Sponsor ICMJE | Hannover Medical School | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Hannover Medical School | ||||||||
| Verification Date | December 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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