Lung TransplantNCT00891865
Viral Triggers in Pediatric Lung Transplantation
An observational study of Lung Transplant and Bronchiolitis Obliterans, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Lung Transplant, Bronchiolitis Obliterans, Obliterative Bronchiolitis
- How many people
- 61 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2009to Apr 2015
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients undergoing lung transplantation
Who may be able to join
- Parent or legal guardian willing and able to provide informed consent
- Participant of first single or bilateral heart-lung transplant
Who cannot join
- Recipient of multi-organ transplant (aside from heart-lung)
- Condition or characteristic which in the opinion of the investigator makes the participant unlikely to complete the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Children's Hospital Boston
Boston, Massachusetts
Nationwide Children's Hospital
Columbus, Ohio, 43205
Texas Children's Hospital
Houston, Texas, 77030
Stanford University
Palo Alto, California, 94305
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, 19104
Washington University
St Louis, Missouri, 63110
About this study
Official title: Viral Triggers of Alloimmunity and Autoimmunity in Pediatric Lung Transplantation (CTOTC-03)
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.
- Keywords
- lung transplant, BOS, OB, Respiratory Viral Infection (RVI), Lung disease
- Medical subject headings
- Bronchiolitis Obliterans, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric lung transplantation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The earliest time to BOS or OB, retransplantation or death
Measured: Within 24 months of transplant
Secondary outcomes (1)
Time to each of the following events: BOS or OB, retransplantation or death
Measured: Within 24 months of transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Stuart Sweet, MD, PhD, Principal investigator, Washington University School of MedicineLara Danziger-Isakov, MD, MPH, Study chair, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891865
- Sponsor's protocol ID
- DAIT CTOTC-03
- Status last verified
- Jun 2020
- First submitted
- 29 Apr 2009
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hayes D Jr, Ballard HO. Saber-sheath trachea in a patient with bronchiolitis obliterans syndrome after lung transplantation. Chron Respir Dis. 2009;6(1):49-52. doi: 10.1177/1479972308099990.
PubMed 19176714Sweet SC. Pediatric lung transplantation. Proc Am Thorac Soc. 2009 Jan 15;6(1):122-7. doi: 10.1513/pats.200808-095GO.
PubMed 19131537Vos R, Vanaudenaerde BM, De Vleeschauwer SI, Van Raemdonck DE, Dupont LJ, Verbeken EK, De Wever W, Verleden GM. Follicular bronchiolitis: a rare cause of bronchiolitis obliterans syndrome after lung transplantation: a case report. Am J Transplant. 2009 Mar;9(3):644-50. doi: 10.1111/j.1600-6143.2008.02518.x. Epub 2009 Feb 3.
PubMed 19191770Yun JJ, Mason DP. Lung transplantation: past, present, and future. Minerva Chir. 2009 Feb;64(1):37-44.
PubMed 19202534Sweet SC, Chin H, Conrad C, Hayes D Jr, Heeger PS, Faro A, Goldfarb S, Melicoff-Portillo E, Mohanakumar T, Odim J, Schecter M, Storch GA, Visner G, Williams NM, Kesler K, Danziger-Isakov L. Absence of evidence that respiratory viral infections influence pediatric lung transplantation outcomes: Results of the CTOTC-03 study. Am J Transplant. 2019 Dec;19(12):3284-3298. doi: 10.1111/ajt.15505. Epub 2019 Jul 25.
PubMed 31216376
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral Triggers of Alloimmunity and Autoimmunity in Pediatric Lung Transplantation (CTOTC-03)
- ClinicalTrials.gov ID
- NCT00891865
- Acronym / sponsor ID
- DAIT CTOTC-03
- Keywords
- lung transplant, BOS, OB, Respiratory Viral Infection (RVI), Lung disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2009
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 May 2009 (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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric lung transplantation | – | – |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients undergoing lung transplantation
Key inclusion criteria (2 listed)
- Parent or legal guardian willing and able to provide informed consent
- Participant of first single or bilateral heart-lung transplant
Key exclusion criteria (2 listed)
- Recipient of multi-organ transplant (aside from heart-lung)
- Condition or characteristic which in the opinion of the investigator makes the participant unlikely to complete the study
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
The earliest time to BOS or OB, retransplantation or death
Time frame: Within 24 months of transplant
1 secondary outcome
Time to each of the following events: BOS or OB, retransplantation or death
Time frame: Within 24 months of transplant
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 2 Jul 2020.
- Background: PubMed 19176714Hayes D Jr, Ballard HO. Saber-sheath trachea in a patient with bronchiolitis obliterans syndrome after lung transplantation. Chron Respir Dis. 2009;6(1):49-52. doi: 10.1177/1479972308099990.
- Background: PubMed 19131537Sweet SC. Pediatric lung transplantation. Proc Am Thorac Soc. 2009 Jan 15;6(1):122-7. doi: 10.1513/pats.200808-095GO.
- Background: PubMed 19191770Vos R, Vanaudenaerde BM, De Vleeschauwer SI, Van Raemdonck DE, Dupont LJ, Verbeken EK, De Wever W, Verleden GM. Follicular bronchiolitis: a rare cause of bronchiolitis obliterans syndrome after lung transplantation: a case report. Am J Transplant. 2009 Mar;9(3):644-50. doi: 10.1111/j.1600-6143.2008.02518.x. Epub 2009 Feb 3.
- Background: PubMed 19202534Yun JJ, Mason DP. Lung transplantation: past, present, and future. Minerva Chir. 2009 Feb;64(1):37-44.
- Results publication: PubMed 31216376Sweet SC, Chin H, Conrad C, Hayes D Jr, Heeger PS, Faro A, Goldfarb S, Melicoff-Portillo E, Mohanakumar T, Odim J, Schecter M, Storch GA, Visner G, Williams NM, Kesler K, Danziger-Isakov L. Absence of evidence that respiratory viral infections influence pediatric lung transplantation outcomes: Results of the CTOTC-03 study. Am J Transplant. 2019 Dec;19(12):3284-3298. doi: 10.1111/ajt.15505. Epub 2019 Jul 25.
Related trials for Lung Transplant
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
RecruitingPhase 1
Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies
Lung Transplantation
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
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.
Stuart Sweet, MD, PhD principal investigator
Washington University School of Medicine
Lara Danziger-Isakov, MD, MPH study chair
Children's Hospital Medical Center, Cincinnati
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant and Bronchiolitis Obliterans, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
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 2 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 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
The earliest time to BOS or OB, retransplantation or death (time frame: Within 24 months of transplant). 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 NCT00891865, which also lists 5 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 2 Jul 2020.