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Trial record 1 of 1 for:    NCT00945555
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Observational Non-Interventional Study Of Febrile Neutropenia Patients To Evaluate Antibacterial Therapeutical Options

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ClinicalTrials.gov Identifier: NCT00945555
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : November 3, 2011
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date July 23, 2009
First Posted Date July 24, 2009
Results First Submitted Date September 23, 2011
Results First Posted Date November 3, 2011
Last Update Posted Date April 5, 2017
Study Start Date June 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 23, 2011)
  • Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical [ Time Frame: Baseline ]
  • Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted [ Time Frame: Baseline ]
Original Primary Outcome Measures
 (submitted: July 23, 2009)
Definition and classification of the antibacterial agents preferred by the Turkish centers monitoring FEN in their therapeutical approach; empirical, targeted.. [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures
 (submitted: November 14, 2011)
  • Mean Body Temperature [ Time Frame: 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) ]
  • Percentage of Participants in Whom New Infection Was Determined on Day 4 [ Time Frame: 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) ]
  • Percentage Survivors [ Time Frame: 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) ]
Original Secondary Outcome Measures
 (submitted: July 23, 2009)
Determination of the efficacy and safety of the used antibacterial agents [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with febrile neutropenia who were planning to take antibacterial treatment.
Condition Febrile 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
Study Groups/Cohorts All participants
Participants with febrile neutropenia who received antibacterial treatment per investigator's judgment
Intervention: Drug: Antibacterial agent for the treatment of febrile neutropenia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 23, 2011)
264
Original Estimated Enrollment
 (submitted: July 23, 2009)
120
Actual Study Completion Date October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT00945555
Other Study ID Numbers A1891006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2017