Febrile Neutropenia
Conditions
Keywords
Antibacterials, Classification of antibacterial agent, Febrile neutropenia, Turkey
Brief summary
The purpose of this study was to define and classify antibacterial agents used in Turkey for patients with febrile neutropenia.
Interventions
DRUGAntibacterial 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
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| Mean Body Temperature | Baseline, Day 4, Day 7 on Average (till the End of Treatment) |
| Percentage of Participants Who Had a Treatment Modification | Day 4, Day 7 on Average (till the End of Treatment) |
| Percentage Survivors | Day 7 on Average (till the End of Treatment) |
| Mean Neutrophil Count | Baseline, Day 4, Day 7 on Average (till the End of Treatment) |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants with febrile neutropenia who received treatment as determined by the physician | 264 |
| Total | 264 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 18 |
| Overall Study | Other | 1 |
| Overall Study | Participant continued treatment at home | 1 |
| Overall Study | Referred to another hospital | 5 |
| Overall Study | Withdrawal by Subject | 2 |
| Overall Study | Worsening condition, intensive care unit | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 42.41 years STANDARD_DEVIATION 16.46 |
| Sex: Female, Male Female | 96 Participants |
| Sex: Female, Male Male | 168 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 264 |
| serious Total, serious adverse events | 4 / 264 |
Outcome results
Primary
Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical
Time frame: Baseline
Population: All participants enrolled in the study. Participants may be counted more than once because they may have received more than one antibacterial agent.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | Cefoperazone/Sulbactam (S) | 33.3 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | Piperacillin-Tazobactam (P) | 32.6 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | Imipenem+Cilastatin Sodium (I) | 26.1 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | Meropenem (M) | 8.0 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | I+Vancomycin | 3.0 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | I+Teicoplanin | 3.0 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | Ceftazidime | 2.7 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | S+Teicoplanin | 1.5 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | P+Teicoplanin | 1.5 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | M+Vancomycin | 1.1 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | P+Moxifloxacin | 0.8 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | M+Teicoplanin | 0.8 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | M+S+Teicoplanin | 0.8 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | P+I | 0.8 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | Teicoplanin+Ceftazidime | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | P+Vancomycin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | P+Clarithromycin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | M+S+Trimethoprim-Sulfamethoxazole | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | M+S+ Teicoplanin+Ofloxacin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | M+S+ Teicoplanin+Colistin Sulfate | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | M+S | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | I+Teicoplanin+Moxifloxacin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | I+S | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | I+P+Teicoplanin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | I+M+S | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | I+M | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | I+Linezolid | 0.4 percentage of participants |
Primary
Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted
Time frame: Baseline
Population: All participants enrolled in the study who received treatment for febrile neutropenia. Number of participants analyzed=number of participants who received an antibacterial drug for the treatment of febrile neutropenia. Participants may be counted more than once because they may have received more than one antibacterial agent.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | I+Ganciclovir | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | Imipenem+Cilastatin Sodium (I) | 34.7 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | Cefoperazone/Sulbactam (S) | 29.0 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | Piperacillin-Tazobactam (P) | 27.8 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | Meropenem (M) | 12.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | I+Teicoplanin (T) | 5.8 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | P+T | 3.9 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | S+T | 3.9 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | I+Vancomycin | 2.7 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | Ceftazidime | 2.3 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | P+Vancomycin | 1.9 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+T | 1.5 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+Vancomycin | 1.5 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | T | 1.2 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | I+Fluconazole (F) | 0.8 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | I+Linezolid (L) | 0.8 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+S+T | 0.8 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | P+Moxifloxacin | 0.8 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | F+I+Vancomycin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | I+Amikacin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | I+Metronidazole | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | I+Ceftazidime | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | I+Ceftriaxone | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | I+Ciprofloxacin+Tigecycline | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | I+T+Amikacin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | I+T+F | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | I+T+Moxifloxacin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | I+Voriconazole (V)+T+Ciprofloxacin+Caspofungin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | L+M+I+Zanamivir | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+I | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+I+Ceftriaxone | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+I+T | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+L | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+S+I | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+S+L+T | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+S+T+Metronidazole | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+S+T+Ofloxacin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+S+Trimethoprim-Sulfamethoxazole (Trimet-Sulfa) | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+T+F+Caspofungin acetate | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+T+Caspofungin acetate | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+T+Ofloxacin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+T+Trimet-Sulfa | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | M+V | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | P+I | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | P+I+F | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | P+I+Vancomycin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | P+Colistin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | P+Levofloxacin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | P+Metronidazole | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | S+I | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | S+I+L+Amphotericin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | S+I+L+Ciprofloxacin+Trimet-Sulfa+Amphotericin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | S+I+L+V+Clarithromycin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | S+I+V+T | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | S+L+T | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | S+M+L+V+T+Trimet-Sulfa+Amphotericin | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | S+Ciprofloxacin+Acyclovir | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | S+T+Acyclovir | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | S+Valaciclovir | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | T+Ceftazidime | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | T+Valaciclovir | 0.4 percentage of participants |
| All Participants | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | V+M+S+T+Valaciclovir | 0.4 percentage of participants |
Secondary
Mean Body Temperature
Time frame: Baseline, Day 4, Day 7 on Average (till the End of Treatment)
Population: All participants enrolled in the study. n=number of participants with available data at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Body Temperature | Baseline (n=264) | 38.5 Degree Celsius | Standard Deviation 0.4 |
| All Participants | Mean Body Temperature | Day 4 (n=261) | 37.4 Degree Celsius | Standard Deviation 0.9 |
| All Participants | Mean Body Temperature | Day 7 on Average (End of Treatment) (n=257) | 36.7 Degree Celsius | Standard Deviation 0.6 |
Secondary
Mean Neutrophil Count
Time frame: Baseline, Day 4, Day 7 on Average (till the End of Treatment)
Population: All participants enrolled in the study. Number of participants analyzed=number of participants with available data. n=number of participants with data available at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Neutrophil Count | Baseline (n=254) | 220.1 neutrophils per cubic millimeter | Standard Deviation 997.2 |
| All Participants | Mean Neutrophil Count | Day 4 (n=239) | 394.8 neutrophils per cubic millimeter | Standard Deviation 2204.7 |
| All Participants | Mean Neutrophil Count | Day 7 on Average (End of Treatment) (n=242) | 1222.1 neutrophils per cubic millimeter | Standard Deviation 3860.3 |
Secondary
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Time frame: Day 7 on Average (till the End of Treatment)
Population: All participants enrolled in the study. Number of participants analyzed = number of participants with new infection diagnosed at end of treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Sinusitis | 3.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Sepsis | 3.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Catheter infection | 23.7 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Bacteriemia | 13.6 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Pneumonia | 8.5 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Primary bloodstream infection | 6.8 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Soft tissue infection | 5.1 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Typhilitis | 5.1 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Urinary tract infection | 5.1 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Fungal pneumonia | 5.1 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Abscess | 5.1 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Fungal infection in lung | 5.1 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Mucositis | 3.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Influenza | 3.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Fever of unknown origin | 3.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Anal fissure+hemorrhoid | 3.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Bloodstream infection originating from catheter | 3.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Tunnel infection | 1.7 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Subdural-intradural hematoma abscess | 1.7 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Pneumocystis pneumonia | 1.7 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Orofaringeal candidiasis | 1.7 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Intra abdominal infection | 1.7 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Herpes labialis | 1.7 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Vancomycin-resistant enterococci in stool | 1.7 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Gastroenteritis | 1.7 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Fusariosis (skin+eye) | 1.7 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | BAL pseudomonas aspergillosa | 1.7 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | Diphtheroid bacillus in 2 blood cultures | 1.7 percentage of participants |
Secondary
Percentage of Participants in Whom New Infection Was Determined on Day 4
Time frame: Day 4
Population: All participants enrolled in the study. Number of participants analyzed=participants with new infection diagnosed on Day 4.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Herpes labialis | 2.8 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Primary bloodstream infection | 15.5 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Bloodstream infection originating from catheter | 14.1 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Urinary tract infection | 11.3 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Catheter infection | 11.3 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Mucositis | 9.9 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Fungal pneumonia | 8.5 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Fungal infection in the lung | 7.0 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Bacteriemia | 7.0 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Oral candidiasis | 4.2 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Pneumonia | 4.2 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Oral mucositis | 4.2 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Dental abscess | 2.8 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Diarrhea | 2.8 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Cellulitis | 2.8 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Influenza | 2.8 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Bronchoalveolar lavage (BAL) legionella | 1.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | BAL Chlamydia Pneumonia | 1.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Cytomegalovirus (CMV) infection | 1.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Deep vein thrombosis+thrombophlebitis | 1.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Diabetic foot infection | 1.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Fever of unknown origin | 1.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Cellulitis gluteal region | 1.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | H1N1 | 1.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Intra-abdominal infection | 1.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Candidemia | 1.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Catheter entry infection | 1.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Oral fungal infection | 1.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Esophagitis | 1.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Consolidation in left lung upper zone | 1.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Typhlitis | 1.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Tunnel infection | 1.4 percentage of participants |
| All Participants | Percentage of Participants in Whom New Infection Was Determined on Day 4 | Tracheal aspiration | 1.4 percentage of participants |
Secondary
Percentage of Participants Who Had a Treatment Modification
Time frame: Day 4, Day 7 on Average (till the End of Treatment)
Population: All participants enrolled in the study. Number of participants analyzed=number of participants who had a treatment modification at any time point. n=number of participants who had data available at that specific time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants Who Had a Treatment Modification | Day 4 (n=258) | 24.8 percentage of participants |
| All Participants | Percentage of Participants Who Had a Treatment Modification | Day 7 on Average (End of Treatment) (n=253) | 50.6 percentage of participants |
Secondary
Percentage Survivors
Time frame: Day 7 on Average (till the End of Treatment)
Population: All participants enrolled in the study. Number of participants analyzed=number of participants with data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage Survivors | 93.0 percentage of participants |