Observational Non-Interventional Study Of Febrile Neutropenia Patients To Evaluate Antibacterial Therapeutical Options
NCT00945555
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- 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.
- Patients who are pregnant or considering pregnancy.
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Descriptive Information | ||||
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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 | 264 | |||
Original Estimated Enrollment | 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:
Exclusion Criteria: - Patients who are pregnant or considering pregnancy. | |||
Sex/Gender |
| |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2017 |