Clinical trial NCT00945555: Observational Non-Interventional Study Of Febrile Neutropenia Patients To Evaluate Antibacterial Therapeutical Options
Official title: Multi-Center, Non-Interventional, Observational Study To Evaluate The Antibacterial Therapeutical Options In Febrile Neutropenia Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Febrile Neutropenia
Keywords: Antibacterials
Classification of antibacterial agent
Febrile neutropenia
Turkey
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-24
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with febrile neutropenia who were planning to take antibacterial treatment.

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


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical
timeFrame: Baseline
measure: Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted
timeFrame: Baseline
Secondary outcomes:
measure: Mean Body Temperature
timeFrame: Baseline, Day 4, Day 7 on Average (till the End of Treatment)
measure: Mean Neutrophil Count
timeFrame: Baseline, Day 4, Day 7 on Average (till the End of Treatment)
measure: Percentage of Participants in Whom New Infection Was Determined on Day 4
timeFrame: Day 4
measure: Percentage of Participants in Whom New Infection Was Determined at End of Treatment
timeFrame: Day 7 on Average (till the End of Treatment)
measure: Percentage Survivors
timeFrame: Day 7 on Average (till the End of Treatment)
measure: Percentage of Participants Who Had a Treatment Modification
timeFrame: Day 4, Day 7 on Average (till the End of Treatment)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Bursa
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Kayseri
country: Turkey
facility: Pfizer Investigational Site
city: Kocaeli
country: Turkey
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: