Viral Triggers in Pediatric Lung Transplantation
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| First Received Date ICMJE | April 29, 2009 | ||||||||
| Last Updated Date | November 14, 2012 | ||||||||
| Start Date ICMJE | June 2009 | ||||||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The earliest time to BOS or OB, retransplantation or death [ Time Frame: Within 24 months of transplant ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00891865 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Time to each of the following events: BOS or OB, retransplantation or death [ Time Frame: Within 24 months of transplant ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Viral Triggers in Pediatric Lung Transplantation | ||||||||
| Official Title ICMJE | Viral Triggers of Alloimmunity and Autoimmunity in Pediatric Lung Transplantation (CTOTC-03) | ||||||||
| Brief Summary | The purpose of this study is to determine whether respiratory viral infections increase the risk of bronchiolitis obliterans syndrome (BOS), obliterative bronchiolitis (OB), death, or retransplantation in children who have received lung transplants. |
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| Detailed Description | Advancements in surgical techniques, preventative measures against infection, recipient selection, and new immunosuppressive regimens have improved short-term outcomes in lung transplant recipients. However, there has been no measurable improvement in long-term survival or outcomes. The cause of many adverse lung transplant outcomes may be related to respiratory viral infections (RVIs). Recent data has identified RVIs as important factors in the development of post-transplant BOS and other adverse outcomes in the pediatric lung transplant population. The purpose of this study is to determine whether respiratory viral infections increase the risk of bronchiolitis obliterans syndrome (BOS), obliterative bronchiolitis (OB), death, or retransplantation in children who have received lung transplants. This study will enroll 80 pediatric lung transplant recipients over a period of 3 years. The study follow-up period will last 2 years. Participants will be enrolled prior to their first lung transplant. The study will consist of 11 study visits coordinated with visits and procedures performed as part of routine care will be used. Study visits will occur prior to transplant, at transplant, weeks 2, 4, 6, months 2, 3, 6, 9, 12, 18 and 24 months after transplant. Blood, bronchoalveolar lavage (BAL), nasal swab and/or tissue samples obtained during routine care will be used. Additional visits will occur if a participant develops symptoms of an RVI, family members and/or cohabitants are diagnosed with an RVI or an unscheduled bronchoscopy is performed for suspicion of rejection or infection. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Blood and nasopharyngeal samples |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Pediatric patients undergoing lung transplantation |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Pediatric lung transplantation | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Estimated Completion Date | May 2014 | ||||||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 21 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Not Provided | ||||||||
| Location Countries ICMJE | United States, United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00891865 | ||||||||
| Other Study ID Numbers ICMJE | DAIT CTOTC-03 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | November 2012 | ||||||||
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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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