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Trial record 8 of 15837 for:    Anti-Bacterial

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

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ClinicalTrials.gov Identifier: NCT00945555
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : November 3, 2011
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Febrile Neutropenia
Intervention Drug: Antibacterial agent for the treatment of febrile neutropenia
Enrollment 264
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description Participants with febrile neutropenia who received treatment as determined by the physician
Period Title: Overall Study
Started 264
Completed 236
Not Completed 28
Reason Not Completed
Referred to another hospital             5
Worsening condition, intensive care unit             1
Withdrawal by Subject             2
Participant continued treatment at home             1
Death             18
Other             1
Arm/Group Title All Participants
Hide Arm/Group Description Participants with febrile neutropenia who received treatment as determined by the physician
Overall Number of Baseline Participants 264
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 264 participants
42.41  (16.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 264 participants
Female
96
  36.4%
Male
168
  63.6%
1.Primary Outcome
Title Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study. Participants may be counted more than once because they may have received more than one antibacterial agent.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants with febrile neutropenia who received treatment as determined by the physician
Overall Number of Participants Analyzed 264
Measure Type: Number
Unit of Measure: percentage of participants
Cefoperazone/Sulbactam (S) 33.3
Piperacillin-Tazobactam (P) 32.6
Imipenem+Cilastatin Sodium (I) 26.1
Meropenem (M) 8.0
I+Vancomycin 3.0
I+Teicoplanin 3.0
Ceftazidime 2.7
S+Teicoplanin 1.5
P+Teicoplanin 1.5
M+Vancomycin 1.1
P+Moxifloxacin 0.8
M+Teicoplanin 0.8
M+S+Teicoplanin 0.8
P+I 0.8
Teicoplanin+Ceftazidime 0.4
P+Vancomycin 0.4
P+Clarithromycin 0.4
M+S+Trimethoprim-Sulfamethoxazole 0.4
M+S+ Teicoplanin+Ofloxacin 0.4
M+S+ Teicoplanin+Colistin Sulfate 0.4
M+S 0.4
I+Teicoplanin+Moxifloxacin 0.4
I+S 0.4
I+P+Teicoplanin 0.4
I+M+S 0.4
I+M 0.4
I+Linezolid 0.4
2.Primary Outcome
Title Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Participants
Hide Arm/Group Description:
Participants with febrile neutropenia who received treatment as determined by the physician
Overall Number of Participants Analyzed 259
Measure Type: Number
Unit of Measure: percentage of participants
Imipenem+Cilastatin Sodium (I) 34.7
Cefoperazone/Sulbactam (S) 29.0
Piperacillin-Tazobactam (P) 27.8
Meropenem (M) 12.4
I+Teicoplanin (T) 5.8
P+T 3.9
S+T 3.9
I+Vancomycin 2.7
Ceftazidime 2.3
P+Vancomycin 1.9
M+T 1.5
M+Vancomycin 1.5
T 1.2
I+Fluconazole (F) 0.8
I+Linezolid (L) 0.8
M+S+T 0.8
P+Moxifloxacin 0.8
F+I+Vancomycin 0.4
I+Amikacin 0.4
I+Ganciclovir 0.4
I+Metronidazole 0.4
I+Ceftazidime 0.4
I+Ceftriaxone 0.4
I+Ciprofloxacin+Tigecycline 0.4
I+T+Amikacin 0.4
I+T+F 0.4
I+T+Moxifloxacin 0.4
I+Voriconazole (V)+T+Ciprofloxacin+Caspofungin 0.4
L+M+I+Zanamivir 0.4
M+I 0.4
M+I+Ceftriaxone 0.4
M+I+T 0.4
M+L 0.4
M+S+I 0.4
M+S+L+T 0.4
M+S+T+Metronidazole 0.4
M+S+T+Ofloxacin 0.4
M+S+Trimethoprim-Sulfamethoxazole (Trimet-Sulfa) 0.4
M+T+F+Caspofungin acetate 0.4
M+T+Caspofungin acetate 0.4
M+T+Ofloxacin 0.4
M+T+Trimet-Sulfa 0.4
M+V 0.4
P+I 0.4
P+I+F 0.4
P+I+Vancomycin 0.4
P+Colistin 0.4
P+Levofloxacin 0.4
P+Metronidazole 0.4
S+I 0.4
S+I+L+Amphotericin 0.4
S+I+L+Ciprofloxacin+Trimet-Sulfa+Amphotericin 0.4
S+I+L+V+Clarithromycin 0.4
S+I+V+T 0.4
S+L+T 0.4
S+M+L+V+T+Trimet-Sulfa+Amphotericin 0.4
S+Ciprofloxacin+Acyclovir 0.4
S+T+Acyclovir 0.4
S+Valaciclovir 0.4
T+Ceftazidime 0.4
T+Valaciclovir 0.4
V+M+S+T+Valaciclovir 0.4
3.Secondary Outcome
Title Mean Body Temperature
Hide Description [Not Specified]
Time Frame Baseline, Day 4, Day 7 on Average (till the End of Treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study. n=number of participants with available data at that time point.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants with febrile neutropenia who received treatment as determined by the physician
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: Degree Celsius
Baseline (n=264) 38.5  (0.4)
Day 4 (n=261) 37.4  (0.9)
Day 7 on Average (End of Treatment) (n=257) 36.7  (0.6)
4.Secondary Outcome
Title Mean Neutrophil Count
Hide Description [Not Specified]
Time Frame Baseline, Day 4, Day 7 on Average (till the End of Treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Participants
Hide Arm/Group Description:
Participants with febrile neutropenia who received treatment as determined by the physician
Overall Number of Participants Analyzed 254
Mean (Standard Deviation)
Unit of Measure: neutrophils per cubic millimeter
Baseline (n=254) 220.1  (997.2)
Day 4 (n=239) 394.8  (2204.7)
Day 7 on Average (End of Treatment) (n=242) 1222.1  (3860.3)
5.Secondary Outcome
Title Percentage of Participants in Whom New Infection Was Determined on Day 4
Hide Description [Not Specified]
Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study. Number of participants analyzed=participants with new infection diagnosed on Day 4.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants with febrile neutropenia who received treatment as determined by the physician
Overall Number of Participants Analyzed 71
Measure Type: Number
Unit of Measure: percentage of participants
Primary bloodstream infection 15.5
Bloodstream infection originating from catheter 14.1
Urinary tract infection 11.3
Catheter infection 11.3
Mucositis 9.9
Fungal pneumonia 8.5
Fungal infection in the lung 7.0
Bacteriemia 7.0
Oral candidiasis 4.2
Pneumonia 4.2
Oral mucositis 4.2
Dental abscess 2.8
Herpes labialis 2.8
Diarrhea 2.8
Cellulitis 2.8
Influenza 2.8
Bronchoalveolar lavage (BAL) legionella 1.4
BAL Chlamydia Pneumonia 1.4
Cytomegalovirus (CMV) infection 1.4
Deep vein thrombosis+thrombophlebitis 1.4
Diabetic foot infection 1.4
Fever of unknown origin 1.4
Cellulitis gluteal region 1.4
H1N1 1.4
Intra-abdominal infection 1.4
Candidemia 1.4
Catheter entry infection 1.4
Oral fungal infection 1.4
Esophagitis 1.4
Consolidation in left lung upper zone 1.4
Typhlitis 1.4
Tunnel infection 1.4
Tracheal aspiration 1.4
6.Secondary Outcome
Title Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Hide Description [Not Specified]
Time Frame Day 7 on Average (till the End of Treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study. Number of participants analyzed = number of participants with new infection diagnosed at end of treatment.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants with febrile neutropenia who received treatment as determined by the physician
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: percentage of participants
Catheter infection 23.7
Bacteriemia 13.6
Pneumonia 8.5
Primary bloodstream infection 6.8
Soft tissue infection 5.1
Typhilitis 5.1
Urinary tract infection 5.1
Fungal pneumonia 5.1
Abscess 5.1
Fungal infection in lung 5.1
Sinusitis 3.4
Sepsis 3.4
Mucositis 3.4
Influenza 3.4
Fever of unknown origin 3.4
Anal fissure+hemorrhoid 3.4
Bloodstream infection originating from catheter 3.4
Tunnel infection 1.7
Subdural-intradural hematoma abscess 1.7
Pneumocystis pneumonia 1.7
Orofaringeal candidiasis 1.7
Intra abdominal infection 1.7
Herpes labialis 1.7
Vancomycin-resistant enterococci in stool 1.7
Gastroenteritis 1.7
Fusariosis (skin+eye) 1.7
BAL pseudomonas aspergillosa 1.7
Diphtheroid bacillus in 2 blood cultures 1.7
7.Secondary Outcome
Title Percentage Survivors
Hide Description [Not Specified]
Time Frame Day 7 on Average (till the End of Treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study. Number of participants analyzed=number of participants with data available.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants with febrile neutropenia who received treatment as determined by the physician
Overall Number of Participants Analyzed 256
Measure Type: Number
Unit of Measure: percentage of participants
93.0
8.Secondary Outcome
Title Percentage of Participants Who Had a Treatment Modification
Hide Description [Not Specified]
Time Frame Day 4, Day 7 on Average (till the End of Treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Participants
Hide Arm/Group Description:
Participants with febrile neutropenia who received treatment as determined by the physician
Overall Number of Participants Analyzed 258
Measure Type: Number
Unit of Measure: percentage of participants
Day 4 (n=258) 24.8
Day 7 on Average (End of Treatment) (n=253) 50.6
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title All Participants
Hide Arm/Group Description Participants with febrile neutropenia who received treatment as determined by the physician
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%) # Events
Total   4/264 (1.52%)    
General disorders   
Chilling, shivering, fever reaction * 1  1/264 (0.38%) 
Systemic allergic reaction-hypotension * 1  1/264 (0.38%) 
Diarrhea * 1  1/264 (0.38%) 
Hepatotoxicity * 1  1/264 (0.38%) 
Elevation of creatinine level * 1  1/264 (0.38%) 
Elevation of transaminase * 1  1/264 (0.38%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Verbatim term
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%) # Events
Total   19/264 (7.20%)    
General disorders   
Diarrhea * 1  2/264 (0.76%)  2
Hepatotoxicity * 1  1/264 (0.38%)  1
Mucositis * 1  1/264 (0.38%)  1
Nausea * 1  1/264 (0.38%)  1
Nausea, vomiting * 1  6/264 (2.27%)  7
Nephrotoxicity * 1  1/264 (0.38%)  1
Rash * 1  8/264 (3.03%)  9
Vomiting-headache * 1  1/264 (0.38%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Verbatim term
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00945555     History of Changes
Other Study ID Numbers: A1891006
First Submitted: July 23, 2009
First Posted: July 24, 2009
Results First Submitted: September 23, 2011
Results First Posted: November 3, 2011
Last Update Posted: April 5, 2017