AdenovirusNCT00448994
Adenovirus and Fungal Load in Pediatric Stem Cell Transplant Patients
An observational study of Adenovirus and Other Mycoses, run by Steven B. Kleiboeker at 2 sites in United States.
Trial summary
This study is designed to determine the rate at which stem cell transplant patients can develop infection caused by a group of viruses, known as adenovirus, and common fungi. Stem cells are unspecialized cells, capable of producing more stem cells or other specialized cells, and are used to replace damaged or diseased… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Adenovirus, Other Mycoses
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2007to Jul 2011
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric
Who may be able to join
- Pediatric patients greater than or equal to 2 years of age.
- Allogeneic HSCT.
- Willing and able to give signed informed consent, or have a legally authorized representative who is willing to give consent. Informed assent will be required for children <18 years of age.
- Reliable and willing to make themselves available for the duration of the study.
Who cannot join
- Autologous transplant patients are not eligible for the study.
- Patients previously enrolled in the study may not reenroll in the event of a subsequent HSCT.
- Pediatric patients less than 2 years of age are not eligible for the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Mercy Hospital
Kansas City, Missouri, 64108
Texas Transplant Institute
San Antonio, Texas, 78229
About this study
Official title: Serial Monitoring of Adenovirus and Fungal Load by Real-Time, Quantitative Polymerase Chain Reaction (PCR) Assay and Correlation With Outcomes in Pediatric Hematopoietic Stem Cell Transplant Patients
This study is designed to determine the rate at which stem cell transplant patients can develop infection caused by a group of viruses, known as adenovirus, and common fungi. Stem cells are unspecialized cells, capable of producing more stem cells or other specialized cells, and are used to replace damaged or diseased cells. The study will be conducted in children (2-17years old) being transplanted with stem cells from a donor. Patients undergoing stem cell transplantation are more likely to develop infections as their immune systems are weakened. Blood, stool, urine and throat swab samples will be collected (for at least 100 days on a weekly basis) to detect infection(s) caused by adenovirus or fungus. Subjects will participate for up to 1 year following the transplant procedure.
Read the detailed description
This study is a multi-center observational study to determine the usefulness of real time PCR in the detection of adenovirus and fungal infections in patients following HSCT. Quantitative viral load monitoring will be evaluated to establish correlation with clinical symptoms and to measure the effectiveness of the therapeutic interventions. Samples will be collected prior to HSCT and on a scheduled weekly basis for 100 days post-HSCT and after that when patients show signs of infection. Patients' signs and symptoms and outcomes will be recorded for correlation with viral load. In addition, viral cultures will be performed on the same schedule as PCR assay using 3 samples (throat swab, stool, and urine). The study will be conducted at approximately 6 centers in the United States.
- Conditions
- Adenovirus, Other Mycoses
- Keywords
- adenovirus, fungal, diagnostics, children
- Medical subject headings
- Adenoviridae Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Method development
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Method development/validation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenovirusStudies 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
- Case only
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven B. Kleiboeker
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Steven B. Kleiboeker, ViraCor Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448994
- Sponsor's protocol ID
- 05-0101
- Status last verified
- Dec 2014
- First submitted
- 15 Mar 2007
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Monitoring of Adenovirus and Fungal Load by Real-Time, Quantitative Polymerase Chain Reaction (PCR) Assay and Correlation With Outcomes in Pediatric Hematopoietic Stem Cell Transplant Patients
- ClinicalTrials.gov ID
- NCT00448994
- Acronym / sponsor ID
- 05-0101
- Conditions
- Adenovirus, Other Mycoses
- Keywords
- adenovirus, fungal, diagnostics, children
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Method development/validation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Steven B. KleiboekerIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Mar 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 Mar 2007 (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.
This study is designed to determine the rate at which stem cell transplant patients can develop infection caused by a group of viruses, known as adenovirus, and common fungi. Stem cells are unspecialized cells, capable of producing more stem cells or other specialized cells, and are used to replace damaged or diseased cells. The study will be conducted in children (2-17years old) being transplanted with stem cells from a donor. Patients undergoing stem cell transplantation are more likely to develop infections as their immune systems are weakened. Blood, stool, urine and throat swab samples will be collected (for at least 100 days on a weekly basis) to detect infection(s) caused by adenovirus or fungus. Subjects will participate for up to 1 year following the transplant procedure.
Detailed description
This study is a multi-center observational study to determine the usefulness of real time PCR in the detection of adenovirus and fungal infections in patients following HSCT. Quantitative viral load monitoring will be evaluated to establish correlation with clinical symptoms and to measure the effectiveness of the therapeutic interventions. Samples will be collected prior to HSCT and on a scheduled weekly basis for 100 days post-HSCT and after that when patients show signs of infection. Patients' signs and symptoms and outcomes will be recorded for correlation with viral load. In addition, viral cultures will be performed on the same schedule as PCR assay using 3 samples (throat swab, stool, and urine). The study will be conducted at approximately 6 centers in the United States.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric
Key inclusion criteria (4 listed)
- Pediatric patients greater than or equal to 2 years of age.
- Allogeneic HSCT.
- Willing and able to give signed informed consent, or have a legally authorized representative who is willing to give consent. Informed assent will be required for children <18 years of age.
- Reliable and willing to make themselves available for the duration of the study.
Key exclusion criteria (3 listed)
- Autologous transplant patients are not eligible for the study.
- Patients previously enrolled in the study may not reenroll in the event of a subsequent HSCT.
- Pediatric patients less than 2 years of age are not eligible for 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
Method development
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
Related trials for Adenovirus
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
Active, not recruitingPhase 1
NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer (LARC)
RecruitingPhase 1
Dose Ranging, Toxicity Seeking, Phase 1 Trial of Oncolytic Adenoviral Therapy for Melanoma Intracranial and Extracranial Metastases
Melanoma
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenovirus and Other Mycoses, run by Steven B. Kleiboeker at 2 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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was withdrawn before enrolling participants, so there are no results.
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?
Method development (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2014.