N/A
N=264
Observational Non-Interventional Study Of Febrile Neutropenia Patients To Evaluate Antibacterial Therapeutical Options
Febrile Neutropenia
Bottom Line
View on ClinicalTrials.gov: NCT00945555 ↗Enrolled (actual)
264
Serious AEs
1.5%
Results posted
Nov 2011
Primary outcome: Primary: Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical — 33.3; 32.6; 26.1; 8.0 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Antibacterial agent for the treatment of febrile neutropenia (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical |
33.3; 32.6; 26.1; 8.0; 3.0; 3.0 | — |
| PRIMARY Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted |
34.7; 29.0; 27.8; 12.4; 5.8; 3.9 | — |
| SECONDARY Mean Body Temperature |
38.5; 37.4; 36.7 | — |
| SECONDARY Mean Neutrophil Count |
220.1; 394.8; 1222.1 | — |
| SECONDARY Percentage of Participants in Whom New Infection Was Determined on Day 4 |
15.5; 14.1; 11.3; 11.3; 9.9; 8.5 | — |
| SECONDARY Percentage of Participants in Whom New Infection Was Determined at End of Treatment |
23.7; 13.6; 8.5; 6.8; 5.1; 5.1 | — |
| SECONDARY Percentage Survivors |
93.0 | — |
| SECONDARY Percentage of Participants Who Had a Treatment Modification |
24.8; 50.6 | — |
Summary
The purpose of this study was to define and classify antibacterial agents used in Turkey for patients with febrile neutropenia.
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.
Data sourced from ClinicalTrials.gov (NCT00945555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.