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UARK 2009-99 A Non-interventional Observational Study of Infectious Complications in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01622595
Recruitment Status : Withdrawn (Principal Investigator has left the institution.)
First Posted : June 19, 2012
Last Update Posted : October 27, 2015
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS

Condition or disease
Aspergillosis Candidemia C. Difficile

Detailed Description:
A NON-INTERVENTIONAL, OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Non-interventional Observational Study of Infectious Complications in Cancer Patients
Study Start Date : November 2009
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. incidence [ Time Frame: 3 years ]

    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
cancer patients with Infections
Criteria

Inclusion Criteria:

  • cancer patients with Infections

Exclusion Criteria:

  • No Infections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622595


Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Senu Apewokin, MD UAMS

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01622595     History of Changes
Other Study ID Numbers: 112265
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015

Keywords provided by University of Arkansas:
Aspergillosis
Candidemia
Candidiasis
C. Difficile
cytomegalovirus
respiratory syncytial virus (RSV)
Influenza
CONS

Additional relevant MeSH terms:
Aspergillosis
Candidemia
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Candidiasis
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes