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

Completed

• Conditions: Febrile Neutropenia
• Interventions: Drug: Antibacterial agent for the treatment of febrile neutropenia

• Registration Number: NCT00945555
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2011-09-23
• Results First Submitted QC: 2011-09-23
• Results First Posted: 2011-11-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	Antibacterial agent for the treatment of febrile neutropenia	Participants with febrile neutropenia who received antibacterial treatment per investigator's judgment

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical	Baseline
Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted	Baseline

Secondary Outcome Measures

Name	Time	Method
Mean Neutrophil Count	Baseline, Day 4, Day 7 on Average (till the End of Treatment)
Percentage of Participants in Whom New Infection Was Determined on Day 4	Day 4
Percentage Survivors	Day 7 on Average (till the End of Treatment)
Percentage of Participants Who Had a Treatment Modification	Day 4, Day 7 on Average (till the End of Treatment)
Mean Body Temperature	Baseline, Day 4, Day 7 on Average (till the End of Treatment)
Percentage of Participants in Whom New Infection Was Determined at End of Treatment	Day 7 on Average (till the End of Treatment)

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇹🇷 Kocaeli, Turkey