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

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ClinicalTrials.gov Identifier: NCT00945555
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : November 3, 2011
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment
Febrile Neutropenia Drug: Antibacterial agent for the treatment of febrile neutropenia

Study Design
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Study Type : Observational
Actual Enrollment : 264 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Center, Non-Interventional, Observational Study To Evaluate The Antibacterial Therapeutical Options In Febrile Neutropenia Patients
Study Start Date : June 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Fever

Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical [ Time Frame: Baseline ]
  2. Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Mean Body Temperature [ Time Frame: Baseline, Day 4, Day 7 on Average (till the End of Treatment) ]
  2. Mean Neutrophil Count [ Time Frame: Baseline, Day 4, Day 7 on Average (till the End of Treatment) ]
  3. Percentage of Participants in Whom New Infection Was Determined on Day 4 [ Time Frame: Day 4 ]
  4. Percentage of Participants in Whom New Infection Was Determined at End of Treatment [ Time Frame: Day 7 on Average (till the End of Treatment) ]
  5. Percentage Survivors [ Time Frame: Day 7 on Average (till the End of Treatment) ]
  6. Percentage of Participants Who Had a Treatment Modification [ Time Frame: Day 4, Day 7 on Average (till the End of Treatment) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00945555


Locations
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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
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00945555    
Other Study ID Numbers: A1891006
First Posted: July 24, 2009    Key Record Dates
Results First Posted: November 3, 2011
Last Update Posted: April 5, 2017
Last Verified: March 2017
Keywords provided by Pfizer:
Antibacterials
Classification of antibacterial agent
Febrile neutropenia
Turkey
Additional relevant MeSH terms:
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Neutropenia
Febrile Neutropenia
Hyperthermia
Fever
Agranulocytosis
Leukopenia
Leukocyte Disorders
 Hematologic Diseases
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries
Anti-Bacterial Agents
Anti-Infective Agents