Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to define and classify antibacterial agents used in Turkey for patients with febrile neutropenia.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Participants with febrile neutropenia who received antibacterial treatment per investigator's judgment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibacterial agent for the treatment of febrile neutropenia | Drug | The antibacterial agent used by the investigators for febrile neutropenia will be determined and classified in the preference order |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Body Temperature | Baseline, Day 4, Day 7 on Average (till the End of Treatment) | |
| Mean Neutrophil Count | Baseline, Day 4, Day 7 on Average (till the End of Treatment) | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Patients who are pregnant or considering pregnancy.
Not provided
Not provided
Not provided
Patients with febrile neutropenia who were planning to take antibacterial treatment.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Kayseri | Turkey | Turkey (Türkiye) | |||
| Pfizer Investigational Site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants with febrile neutropenia who received treatment as determined by the physician |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
| Percentage Survivors | 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) |
| Kocaeli |
| Turkey |
| Turkey (Türkiye) |
| Pfizer Investigational Site | Ankara | 06500 | Turkey (Türkiye) |
| Pfizer Investigational Site | Bursa | Turkey (Türkiye) |
| Pfizer Investigational Site | Istanbul | Turkey (Türkiye) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants with febrile neutropenia who received treatment as determined by the physician |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical | All participants enrolled in the study. Participants may be counted more than once because they may have received more than one antibacterial agent. | Posted | Number | percentage of participants | Baseline |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted | 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. | Posted | Number | percentage of participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Body Temperature | All participants enrolled in the study. n=number of participants with available data at that time point. | Posted | Mean | Standard Deviation | Degree Celsius | Baseline, Day 4, Day 7 on Average (till the End of Treatment) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Mean Neutrophil Count | 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. | Posted | Mean | Standard Deviation | neutrophils per cubic millimeter | Baseline, Day 4, Day 7 on Average (till the End of Treatment) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Whom New Infection Was Determined on Day 4 | All participants enrolled in the study. Number of participants analyzed=participants with new infection diagnosed on Day 4. | Posted | Number | percentage of participants | Day 4 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Whom New Infection Was Determined at End of Treatment | All participants enrolled in the study. Number of participants analyzed = number of participants with new infection diagnosed at end of treatment. | Posted | Number | percentage of participants | Day 7 on Average (till the End of Treatment) |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Survivors | All participants enrolled in the study. Number of participants analyzed=number of participants with data available. | Posted | Number | percentage of participants | Day 7 on Average (till the End of Treatment) |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Had a Treatment Modification | 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. | Posted | Number | percentage of participants | Day 4, Day 7 on Average (till the End of Treatment) |
|
|
Not provided
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Participants with febrile neutropenia who received treatment as determined by the physician | 4 | 264 | 19 | 264 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chilling, shivering, fever reaction | General disorders | Verbatim term | Non-systematic Assessment |
| |
| Systemic allergic reaction-hypotension | General disorders | Verbatim term | Non-systematic Assessment |
| |
| Diarrhea | General disorders | Verbatim term | Non-systematic Assessment |
| |
| Hepatotoxicity | General disorders | Verbatim term | Non-systematic Assessment |
| |
| Elevation of creatinine level | General disorders | Verbatim term | Non-systematic Assessment |
| |
| Elevation of transaminase | General disorders | Verbatim term | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | General disorders | Verbatim term | Non-systematic Assessment |
| |
| Hepatotoxicity | General disorders | Verbatim term | Non-systematic Assessment |
| |
| Mucositis | General disorders | Verbatim term | Non-systematic Assessment |
| |
| Nausea | General disorders | Verbatim term | Non-systematic Assessment |
| |
| Nausea, vomiting | General disorders | Verbatim term | Non-systematic Assessment |
| |
| Nephrotoxicity | General disorders | Verbatim term | Non-systematic Assessment |
| |
| Rash | General disorders | Verbatim term | Non-systematic Assessment |
| |
| Vomiting-headache | General disorders | Verbatim term | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Meropenem (M) |
|
| I+Vancomycin |
|
| I+Teicoplanin |
|
| Ceftazidime |
|
| S+Teicoplanin |
|
| P+Teicoplanin |
|
| M+Vancomycin |
|
| P+Moxifloxacin |
|
| M+Teicoplanin |
|
| M+S+Teicoplanin |
|
| P+I |
|
| Teicoplanin+Ceftazidime |
|
| P+Vancomycin |
|
| P+Clarithromycin |
|
| M+S+Trimethoprim-Sulfamethoxazole |
|
| M+S+ Teicoplanin+Ofloxacin |
|
| M+S+ Teicoplanin+Colistin Sulfate |
|
| M+S |
|
| I+Teicoplanin+Moxifloxacin |
|
| I+S |
|
| I+P+Teicoplanin |
|
| I+M+S |
|
| I+M |
|
| I+Linezolid |
|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Baseline (n=264) |
| |||||
| Day 4 (n=261) |
| |||||
| Day 7 on Average (End of Treatment) (n=257) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Baseline (n=254) |
| |||||
| Day 4 (n=239) |
| |||||
| Day 7 on Average (End of Treatment) (n=242) |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Primary bloodstream infection |
| |||||
| Bloodstream infection originating from catheter |
| |||||
| Urinary tract infection |
| |||||
| Catheter infection |
| |||||
| Mucositis |
| |||||
| Fungal pneumonia |
| |||||
| Fungal infection in the lung |
| |||||
| Bacteriemia |
| |||||
| Oral candidiasis |
| |||||
| Pneumonia |
| |||||
| Oral mucositis |
| |||||
| Dental abscess |
| |||||
| Herpes labialis |
| |||||
| Diarrhea |
| |||||
| Cellulitis |
| |||||
| Influenza |
| |||||
| Bronchoalveolar lavage (BAL) legionella |
| |||||
| BAL Chlamydia Pneumonia |
| |||||
| Cytomegalovirus (CMV) infection |
| |||||
| Deep vein thrombosis+thrombophlebitis |
| |||||
| Diabetic foot infection |
| |||||
| Fever of unknown origin |
| |||||
| Cellulitis gluteal region |
| |||||
| H1N1 |
| |||||
| Intra-abdominal infection |
| |||||
| Candidemia |
| |||||
| Catheter entry infection |
| |||||
| Oral fungal infection |
| |||||
| Esophagitis |
| |||||
| Consolidation in left lung upper zone |
| |||||
| Typhlitis |
| |||||
| Tunnel infection |
| |||||
| Tracheal aspiration |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Catheter infection |
| |||||
| Bacteriemia |
| |||||
| Pneumonia |
| |||||
| Primary bloodstream infection |
| |||||
| Soft tissue infection |
| |||||
| Typhilitis |
| |||||
| Urinary tract infection |
| |||||
| Fungal pneumonia |
| |||||
| Abscess |
| |||||
| Fungal infection in lung |
| |||||
| Sinusitis |
| |||||
| Sepsis |
| |||||
| Mucositis |
| |||||
| Influenza |
| |||||
| Fever of unknown origin |
| |||||
| Anal fissure+hemorrhoid |
| |||||
| Bloodstream infection originating from catheter |
| |||||
| Tunnel infection |
| |||||
| Subdural-intradural hematoma abscess |
| |||||
| Pneumocystis pneumonia |
| |||||
| Orofaringeal candidiasis |
| |||||
| Intra abdominal infection |
| |||||
| Herpes labialis |
| |||||
| Vancomycin-resistant enterococci in stool |
| |||||
| Gastroenteritis |
| |||||
| Fusariosis (skin+eye) |
| |||||
| BAL pseudomonas aspergillosa |
| |||||
| Diphtheroid bacillus in 2 blood cultures |
|
| Denominators |
|---|
| Categories |
|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Day 4 (n=258) |
| |||||
| Day 7 on Average (End of Treatment) (n=253) |
|