NCT00945555

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 3, 2011

Completed
Last Updated

April 5, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

July 23, 2009

Results QC Date

September 23, 2011

Last Update Submit

March 7, 2017

Conditions

Febrile Neutropenia

Keywords

AntibacterialsClassification of antibacterial agentFebrile neutropeniaTurkey

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Mean Body Temperature

    Baseline, Day 4, Day 7 on Average (till the End of Treatment)

  • 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 of Participants in Whom New Infection Was Determined at End of Treatment

    Day 7 on Average (till the End of Treatment)

  • Percentage Survivors

    Day 7 on Average (till the End of Treatment)

  • +1 more secondary outcomes

Study Arms (1)

All participants

Participants with febrile neutropenia who received antibacterial treatment per investigator's judgment

Drug: Antibacterial agent for the treatment of febrile neutropenia

Interventions

Antibacterial agent for the treatment of febrile neutropeniaDRUG

The antibacterial agent used by the investigators for febrile neutropenia will be determined and classified in the preference order

All participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • \- Patients who are pregnant or considering pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pfizer Investigational Site

Kayseri, Turkey, Turkey (Türkiye)

Location

Pfizer Investigational Site

Kocaeli, Turkey, Turkey (Türkiye)

Location

Pfizer Investigational Site

Ankara, 06500, Turkey (Türkiye)

Location

Pfizer Investigational Site

Bursa, Turkey (Türkiye)

Location

Pfizer Investigational Site

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Febrile Neutropenia

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

NeutropeniaAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 24, 2009

Study Start

June 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

April 5, 2017

Results First Posted

November 3, 2011

Record last verified: 2017-03

Locations

TU(5)