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

Febrile Neutropenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945555
• Other study ID #: A1891006
• Status: Completed
• Phase: Phase 4
• First received: July 23, 2009
• Last updated: November 14, 2011
• Start date: June 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Neutropenia

Intervention

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

Locations

Country	Name	City	State
Turkey	Pfizer Investigational Site	Ankara
Turkey	Pfizer Investigational Site	Bursa
Turkey	Pfizer Investigational Site	Istanbul
Turkey	Pfizer Investigational Site	Kayseri
Turkey	Pfizer Investigational Site	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical		Baseline	No
Primary	Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted		Baseline	No
Secondary	Mean Body Temperature		Baseline, Day 4, Day 7 on Average (till the End of Treatment)	No
Secondary	Mean Neutrophil Count		Baseline, Day 4, Day 7 on Average (till the End of Treatment)	No
Secondary	Percentage of Participants in Whom New Infection Was Determined on Day 4		Day 4	No
Secondary	Percentage of Participants in Whom New Infection Was Determined at End of Treatment		Day 7 on Average (till the End of Treatment)	No
Secondary	Percentage Survivors		Day 7 on Average (till the End of Treatment)	No
Secondary	Percentage of Participants Who Had a Treatment Modification		Day 4, Day 7 on Average (till the End of Treatment)	No

External Links

•   To obtain contact information for a study center near you, click here.