Trial Outcomes & Findings for Observational Non-Interventional Study Of Febrile Neutropenia Patients To Evaluate Antibacterial Therapeutical Options (NCT NCT00945555)
NCT ID: NCT00945555
Last Updated: 2017-04-05
Results Overview
Recruitment status
COMPLETED
Target enrollment
264 participants
Primary outcome timeframe
Baseline
Results posted on
2017-04-05
Participant Flow
Participant milestones
| Measure |
All Participants
Participants with febrile neutropenia who received treatment as determined by the physician
|
|---|---|
|
Overall Study
STARTED
|
264
|
|
Overall Study
COMPLETED
|
236
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
All Participants
Participants with febrile neutropenia who received treatment as determined by the physician
|
|---|---|
|
Overall Study
Referred to another hospital
|
5
|
|
Overall Study
Worsening condition, intensive care unit
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Participant continued treatment at home
|
1
|
|
Overall Study
Death
|
18
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Observational Non-Interventional Study Of Febrile Neutropenia Patients To Evaluate Antibacterial Therapeutical Options
Baseline characteristics by cohort
| Measure |
All Participants
n=264 Participants
Participants with febrile neutropenia who received treatment as determined by the physician
|
|---|---|
|
Age, Continuous
|
42.41 years
STANDARD_DEVIATION 16.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
168 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: All participants enrolled in the study. Participants may be counted more than once because they may have received more than one antibacterial agent.
Outcome measures
| Measure |
All Participants
n=264 Participants
Participants with febrile neutropenia who received treatment as determined by the physician
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: BaselinePopulation: 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.
Outcome measures
| Measure |
All Participants
n=259 Participants
Participants with febrile neutropenia who received treatment as determined by the physician
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted
Ceftazidime
|
2.3 percentage of 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
|
|
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
|
|
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
|
|
Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted
T
|
1.2 percentage of 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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
Outcome measures
| Measure |
All Participants
n=264 Participants
Participants with febrile neutropenia who received treatment as determined by the physician
|
|---|---|
|
Mean Body Temperature
Day 4 (n=261)
|
37.4 Degree Celsius
Standard Deviation 0.9
|
|
Mean Body Temperature
Baseline (n=264)
|
38.5 Degree Celsius
Standard Deviation 0.4
|
|
Mean Body Temperature
Day 7 on Average (End of Treatment) (n=257)
|
36.7 Degree Celsius
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Participants
n=254 Participants
Participants with febrile neutropenia who received treatment as determined by the physician
|
|---|---|
|
Mean Neutrophil Count
Baseline (n=254)
|
220.1 neutrophils per cubic millimeter
Standard Deviation 997.2
|
|
Mean Neutrophil Count
Day 4 (n=239)
|
394.8 neutrophils per cubic millimeter
Standard Deviation 2204.7
|
|
Mean Neutrophil Count
Day 7 on Average (End of Treatment) (n=242)
|
1222.1 neutrophils per cubic millimeter
Standard Deviation 3860.3
|
SECONDARY outcome
Timeframe: Day 4Population: All participants enrolled in the study. Number of participants analyzed=participants with new infection diagnosed on Day 4.
Outcome measures
| Measure |
All Participants
n=71 Participants
Participants with febrile neutropenia who received treatment as determined by the physician
|
|---|---|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Primary bloodstream infection
|
15.5 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Bloodstream infection originating from catheter
|
14.1 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Urinary tract infection
|
11.3 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Catheter infection
|
11.3 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Mucositis
|
9.9 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Fungal pneumonia
|
8.5 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Fungal infection in the lung
|
7.0 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Bacteriemia
|
7.0 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Oral candidiasis
|
4.2 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Pneumonia
|
4.2 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Oral mucositis
|
4.2 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Dental abscess
|
2.8 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Herpes labialis
|
2.8 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Diarrhea
|
2.8 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Cellulitis
|
2.8 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Influenza
|
2.8 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Bronchoalveolar lavage (BAL) legionella
|
1.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
BAL Chlamydia Pneumonia
|
1.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Cytomegalovirus (CMV) infection
|
1.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Deep vein thrombosis+thrombophlebitis
|
1.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Diabetic foot infection
|
1.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Fever of unknown origin
|
1.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Cellulitis gluteal region
|
1.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
H1N1
|
1.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Intra-abdominal infection
|
1.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Candidemia
|
1.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Catheter entry infection
|
1.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Oral fungal infection
|
1.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Esophagitis
|
1.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Consolidation in left lung upper zone
|
1.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Typhlitis
|
1.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Tunnel infection
|
1.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined on Day 4
Tracheal aspiration
|
1.4 percentage of participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Participants
n=59 Participants
Participants with febrile neutropenia who received treatment as determined by the physician
|
|---|---|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Catheter infection
|
23.7 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Bacteriemia
|
13.6 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Pneumonia
|
8.5 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Primary bloodstream infection
|
6.8 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Soft tissue infection
|
5.1 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Typhilitis
|
5.1 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Urinary tract infection
|
5.1 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Fungal pneumonia
|
5.1 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Abscess
|
5.1 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Fungal infection in lung
|
5.1 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Sinusitis
|
3.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Sepsis
|
3.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Mucositis
|
3.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Influenza
|
3.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Fever of unknown origin
|
3.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Anal fissure+hemorrhoid
|
3.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Bloodstream infection originating from catheter
|
3.4 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Tunnel infection
|
1.7 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Subdural-intradural hematoma abscess
|
1.7 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Pneumocystis pneumonia
|
1.7 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Orofaringeal candidiasis
|
1.7 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Intra abdominal infection
|
1.7 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Herpes labialis
|
1.7 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Vancomycin-resistant enterococci in stool
|
1.7 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Gastroenteritis
|
1.7 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Fusariosis (skin+eye)
|
1.7 percentage of participants
|
|
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
BAL pseudomonas aspergillosa
|
1.7 percentage of 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 outcome
Timeframe: 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.
Outcome measures
| Measure |
All Participants
n=256 Participants
Participants with febrile neutropenia who received treatment as determined by the physician
|
|---|---|
|
Percentage Survivors
|
93.0 percentage of participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Participants
n=258 Participants
Participants with febrile neutropenia who received treatment as determined by the physician
|
|---|---|
|
Percentage of Participants Who Had a Treatment Modification
Day 4 (n=258)
|
24.8 percentage of participants
|
|
Percentage of Participants Who Had a Treatment Modification
Day 7 on Average (End of Treatment) (n=253)
|
50.6 percentage of participants
|
Adverse Events
All Participants
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Participants
n=264 participants at risk
Participants with febrile neutropenia who received treatment as determined by the physician
|
|---|---|
|
General disorders
Elevation of creatinine level
|
0.38%
1/264
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Elevation of transaminase
|
0.38%
1/264
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chilling, shivering, fever reaction
|
0.38%
1/264
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Systemic allergic reaction-hypotension
|
0.38%
1/264
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Diarrhea
|
0.38%
1/264
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Hepatotoxicity
|
0.38%
1/264
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
All Participants
n=264 participants at risk
Participants with febrile neutropenia who received treatment as determined by the physician
|
|---|---|
|
General disorders
Diarrhea
|
0.76%
2/264 • Number of events 2
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Hepatotoxicity
|
0.38%
1/264 • Number of events 1
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Mucositis
|
0.38%
1/264 • Number of events 1
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Nausea
|
0.38%
1/264 • Number of events 1
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Nausea, vomiting
|
2.3%
6/264 • Number of events 7
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Nephrotoxicity
|
0.38%
1/264 • Number of events 1
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Rash
|
3.0%
8/264 • Number of events 9
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Vomiting-headache
|
0.38%
1/264 • Number of events 1
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER