Solid Organ TransplantNCT00518778
Fusariosis in Solid-Organ Transplant Recipients
An observational study of Solid Organ Transplant and Fusariosis, run by University of Pittsburgh at 1 site in United States.
Trial summary
This exempt chart review study will try to determine the clinical presentation, prognostic factors, response to different treatment modalities and mortality among patients diagnosed with fusariosis after solid-organ transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Organ Transplant, Fusariosis
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Solid organ transplant patients diagnosed with fusariosis
Who may be able to join
- Solid-organ transplants (liver, kidney, lung, heart, pancreas, small bowel transplant) diagnosed with fusariosis or infections due to Fusarium, species in our institution
Who cannot join
- Those subjects that do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
This exempt chart review study will try to determine the clinical presentation, prognostic factors, response to different treatment modalities and mortality among patients diagnosed with fusariosis after solid-organ transplantation.
Read the detailed description
This exempt chart review study will try to determine the clinical presentation, prognostic factors, response to different treatment modalities and mortality among patients diagnosed with fusariosis after solid-organ transplantation.This will help determine prognostic factors, response to different treatment modalities and mortality among patients diagnosed with fusariosis after solid-organ transplantation.
- Conditions
- Solid Organ Transplant, Fusariosis
- Keywords
- fusariosis, solid organ transplants
- Medical subject headings
- Fusariosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startAug 2007
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ TransplantStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- Adarsh Bhimraj, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518778
- Sponsor's protocol ID
- PRO07070159
- Other IDs
- investigator funding
- Status last verified
- Dec 2009
- First submitted
- 17 Aug 2007
- Last updated
- 3 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fusariosis in Solid-Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT00518778
- Acronym / sponsor ID
- PRO07070159
- Conditions
- Solid Organ Transplant, Fusariosis
- Keywords
- fusariosis, solid organ transplants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2007
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Aug 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 exempt chart review study will try to determine the clinical presentation, prognostic factors, response to different treatment modalities and mortality among patients diagnosed with fusariosis after solid-organ transplantation.
Detailed description
This exempt chart review study will try to determine the clinical presentation, prognostic factors, response to different treatment modalities and mortality among patients diagnosed with fusariosis after solid-organ transplantation.This will help determine prognostic factors, response to different treatment modalities and mortality among patients diagnosed with fusariosis after solid-organ transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Solid organ transplant patients diagnosed with fusariosis
Key inclusion criteria (1 listed)
- Solid-organ transplants (liver, kidney, lung, heart, pancreas, small bowel transplant) diagnosed with fusariosis or infections due to Fusarium, species in our institution
Key exclusion criteria (1 listed)
- Those subjects that do not meet inclusion criteria
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
Not reported in the source record.
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 3 Dec 2009.
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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.
Adarsh Bhimraj, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Organ Transplant and Fusariosis, run by University of Pittsburgh at 1 site 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 1 inclusion and 1 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 3 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 3 Dec 2009.