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

Last updated on November 5, 2019

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Study Location
Pfizer Investigational Site
Ankara, , 06500 Turkey
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Febrile Neutropenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients who are pregnant or considering pregnancy.

NCT00945555
Pfizer
Completed
Observational Non-Interventional Study Of Febrile Neutropenia Patients To Evaluate Antibacterial Therapeutical Options

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Descriptive Information
Brief TitleObservational Non-Interventional Study Of Febrile Neutropenia Patients To Evaluate Antibacterial Therapeutical Options
Official TitleMulti-Center, Non-Interventional, Observational Study To Evaluate The Antibacterial Therapeutical Options In Febrile Neutropenia Patients
Brief SummaryThe purpose of this study was to define and classify antibacterial agents used in Turkey for patients with febrile neutropenia.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients with febrile neutropenia who were planning to take antibacterial treatment.
ConditionFebrile Neutropenia
InterventionDrug: 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/CohortsAll 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 StatusCompleted
Actual Enrollment
 (submitted: September 23, 2011)
264
Original Estimated Enrollment
 (submitted: July 23, 2009)
120
Actual Study Completion DateOctober 2010
Actual Primary Completion DateOctober 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesTurkey
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00945555
Other Study ID NumbersA1891006
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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