AspergillosisNCT01622595
UARK 2009-99 A Non-interventional Observational Study of Infectious Complications in Cancer Patients
An observational study of Aspergillosis and Candidemia, run by University of Arkansas at 1 site in United States.
Trial summary
OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspergillosis, Candidemia, C. Difficile
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cancer patients with Infections
Who may be able to join
- cancer patients with Infections
Who cannot join
- No Infections
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: A Non-interventional Observational Study of Infectious Complications in Cancer Patients
OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS
Read the detailed description
A NON-INTERVENTIONAL, OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS
- Conditions
- Aspergillosis, Candidemia, C. Difficile
- Keywords
- Aspergillosis, Candidemia, Candidiasis, C. Difficile, cytomegalovirus, respiratory syncytial virus (RSV), Influenza, CONS
- Medical subject headings
- Aspergillosis, Candidemia, Candidiasis, Influenza, Human
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the incidence, risk factors, clinical presentation, diagnosis and prognostic factors of infectious complications in cancer patients
To study the incidence, risk factors, clinical presentation, diagnosis and prognostic factors of infectious complications in cancer patients
Measured: 3 years
Secondary outcomes (1)
incidence
To determine the overall incidence of different infections, including bacterial, fungal and viral infections in cancer patients receiving chemotherapy and / or hematopoietic stem cell transplantation.
- To describe the natural history of such infections in cancer patients.
- To monitor the adherence of Myeloma institute for research and therapy(MIRT) health care workers to the MIRT standard operational procedures (SOPs)
- To identify risk factors for the development of specific infections.
- To validate surrogate markers as early diagnostic tools for various infections.
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 Jun 2012 (estimated)
- Study startNov 2009
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Principal Investigator has left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AspergillosisStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Senu Apewokin, MD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622595
- Sponsor's protocol ID
- 112265
- Status last verified
- Oct 2015
- First submitted
- 15 Jun 2012
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Observational Study of Infectious Complications in Cancer Patients
- ClinicalTrials.gov ID
- NCT01622595
- Acronym / sponsor ID
- 112265
- Conditions
- Aspergillosis, Candidemia, C. Difficile
- Keywords
- Aspergillosis, Candidemia, Candidiasis, C. Difficile, cytomegalovirus, respiratory syncytial virus (RSV), Influenza, CONS
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Principal Investigator has left the institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 19 Jun 2012 (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.
OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS
Detailed description
A NON-INTERVENTIONAL, OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cancer patients with Infections
Key inclusion criteria (1 listed)
- cancer patients with Infections
Key exclusion criteria (1 listed)
- No Infections
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
To study the incidence, risk factors, clinical presentation, diagnosis and prognostic factors of infectious complications in cancer patients
Time frame: 3 years
To study the incidence, risk factors, clinical presentation, diagnosis and prognostic factors of infectious complications in cancer patients
1 secondary outcome
incidence
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 27 Oct 2015.
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A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
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Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
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A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis
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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.
Senu Apewokin, MD principal investigator
UAMS
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 Aspergillosis and Candidemia, run by University of Arkansas 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: withdrawn, as of the sponsor's last update on 27 Oct 2015. 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 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?
To study the incidence, risk factors, clinical presentation, diagnosis and prognostic factors of infectious complications in cancer patients (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 27 Oct 2015.