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

This study is currently recruiting participants.
Verified February 2014 by University of Arkansas
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01622595
First received: June 15, 2012
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS


Condition
Aspergillosis
Candidemia
C. Difficile

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Non-interventional Observational Study of Infectious Complications in Cancer Patients

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • To study the incidence, risk factors, clinical presentation, diagnosis and prognostic factors of infectious complications in cancer patients [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To study the incidence, risk factors, clinical presentation, diagnosis and prognostic factors of infectious complications in cancer patients


Secondary Outcome Measures:
  • incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 600
Study Start Date: November 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622595

Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Naveen s, MD, MHSA    501-681-1972    nsanathkumar@uams.edu   
Principal Investigator: Senu Apewokin, MD         
Sub-Investigator: Naveen Sanath Kumar, MD, MHSA         
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Senu Apewokin, MD UAMS
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01622595     History of Changes
Other Study ID Numbers: UARK 2009-99
Study First Received: June 15, 2012
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration

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
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Candidiasis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014