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

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:

Genetics Home Reference related topics: cyclic neutropenia

MedlinePlus related topics: Antibiotics Fever

U.S. FDA Resources

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

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

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:

Fever
Neutropenia
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
Leukopenia

Leukocyte Disorders
Hematologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013