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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 19, 2014
Last verified: August 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 2015
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 19, 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
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Fungemia
Sepsis
Candidiasis, Invasive
Candidiasis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014