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

March 7, 2017 updated by: Pfizer

Multi-Center, Non-Interventional, Observational Study To Evaluate The Antibacterial Therapeutical Options In Febrile Neutropenia Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

264

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06500
        • Pfizer Investigational Site
      • Bursa, Turkey
        • Pfizer Investigational Site
      • Istanbul, Turkey
        • Pfizer Investigational Site
      • Kayseri, Turkey
        • Pfizer Investigational Site
      • Kocaeli, Turkey
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 23, 2009

First Posted (Estimate)

July 24, 2009

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1891006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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