Observational Non-Interventional Study Of Febrile Neutropenia Patients To Evaluate Antibacterial Therapeutical Options

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00945555
First received: July 23, 2009
Last updated: November 14, 2011
Last verified: November 2011
  Purpose

The purpose of this study was to define and classify antibacterial agents used in Turkey for patients with febrile neutropenia.


Condition Intervention Phase
Febrile Neutropenia
Drug: Antibacterial agent for the treatment of febrile neutropenia
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Center, Non-Interventional, Observational Study To Evaluate The Antibacterial Therapeutical Options In Febrile Neutropenia Patients

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Body Temperature [ Time Frame: Baseline, Day 4, Day 7 on Average (till the End of Treatment) ] [ Designated as safety issue: No ]
  • Mean Neutrophil Count [ Time Frame: Baseline, Day 4, Day 7 on Average (till the End of Treatment) ] [ Designated as safety issue: No ]
  • Percentage of Participants in Whom New Infection Was Determined on Day 4 [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
  • Percentage of Participants in Whom New Infection Was Determined at End of Treatment [ Time Frame: Day 7 on Average (till the End of Treatment) ] [ Designated as safety issue: No ]
  • Percentage Survivors [ Time Frame: Day 7 on Average (till the End of Treatment) ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Had a Treatment Modification [ Time Frame: Day 4, Day 7 on Average (till the End of Treatment) ] [ Designated as safety issue: No ]

Enrollment: 264
Study Start Date: June 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All participants
Participants with febrile neutropenia who received antibacterial treatment per investigator's judgment
Drug: Antibacterial agent for the treatment of febrile neutropenia
The antibacterial agent used by the investigators for febrile neutropenia will be determined and classified in the preference order

  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

Patients with febrile neutropenia who were planning to take antibacterial treatment.

Criteria

Inclusion Criteria:

  • Patients who are 18 years old and above.
  • Patients who have undergone allogeneic/autologous or peripheral stem cell transplantation following induction or consolidation treatment due to acute hematological malignancy.
  • Patients who have a neutrophil count below 500 cells per cubic millimeter (cells/mm^3) or below 1000 cells/mm^3 with an expectancy to rapidly decrease below 500 cells/mm^3.
  • Patients with a body temperature more than or equal to (≥)38.3 degrees Celsius (101 degrees Fahrenheit) on single oral measurement or detected ≥38.0 degrees Celsius for at least an hour and thus started on antibacterial treatment will be included in the trial.

Exclusion Criteria:

- Patients who are pregnant or considering pregnancy.

  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: NCT00945555

Locations
Turkey
Pfizer Investigational Site
Ankara, Turkey, 06500
Pfizer Investigational Site
Bursa, Turkey
Pfizer Investigational Site
Istanbul, Turkey
Pfizer Investigational Site
Kayseri, Turkey
Pfizer Investigational Site
Kocaeli, Turkey
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00945555     History of Changes
Other Study ID Numbers: A1891006
Study First Received: July 23, 2009
Results First Received: September 23, 2011
Last Updated: November 14, 2011
Health Authority: Turkey: Ministry of Health

Keywords provided by Pfizer:
Antibacterials
Classification of antibacterial agent
Febrile neutropenia
Turkey

Additional relevant MeSH terms:
Neutropenia
Fever
Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014