Febrile NeutropeniaNCT00945555
Observational Non-Interventional Study Of Febrile Neutropenia Patients To Evaluate Antibacterial Therapeutical Options
An observational study of Febrile Neutropenia, run by Pfizer at 5 sites in Turkey (Türkiye).
Trial summary
The purpose of this study was to define and classify antibacterial agents used in Turkey for patients with febrile neutropenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Febrile Neutropenia
- What is being tested?
- Antibacterial agent for the treatment of febrile neutropenia
- How many people
- 264 participants
- Where
- 5 sitesTurkey (Türkiye)
- Study dates
- Jun 2009to Oct 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with febrile neutropenia who were planning to take antibacterial treatment.
Who may be able to join
- 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.
Who cannot join
- Patients who are pregnant or considering pregnancy.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Turkey (Türkiye)5 sites
Pfizer Investigational Site
Ankara, 06500
Pfizer Investigational Site
Bursa
Pfizer Investigational Site
Istanbul
Pfizer Investigational Site
Kayseri, Turkey
Pfizer Investigational Site
Kocaeli, Turkey
About this study
Official title: Multi-Center, Non-Interventional, Observational Study To Evaluate The Antibacterial Therapeutical Options In Febrile Neutropenia Patients
The purpose of this study was to define and classify antibacterial agents used in Turkey for patients with febrile neutropenia.
- Conditions
- Febrile Neutropenia
- Being tested
- Antibacterial agent for the treatment of febrile neutropenia
- Keywords
- Antibacterials, Classification of antibacterial agent, Febrile neutropenia, Turkey
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibacterial agent for the treatment of febrile neutropeniaDrug
The antibacterial agent used by the investigators for febrile neutropenia will be determined and classified in the preference order
| Study group | Role | What they receive |
|---|---|---|
| All participants | Participants with febrile neutropenia who received antibacterial treatment per investigator's judgment Receives: Drug: Antibacterial agent for the treatment of febrile neutropenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical
Measured: Baseline
Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted
Measured: Baseline
Secondary outcomes (6)
Mean Body Temperature
Measured: Baseline, Day 4, Day 7 on Average (till the End of Treatment)
Mean Neutrophil Count
Measured: Baseline, Day 4, Day 7 on Average (till the End of Treatment)
Percentage of Participants in Whom New Infection Was Determined on Day 4
Measured: Day 4
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Measured: Day 7 on Average (till the End of Treatment)
Percentage Survivors
Measured: Day 7 on Average (till the End of Treatment)
Percentage of Participants Who Had a Treatment Modification
Measured: Day 4, Day 7 on Average (till the End of Treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945555
- Sponsor's protocol ID
- A1891006
- Status last verified
- Mar 2017
- First submitted
- 23 Jul 2009
- Last updated
- 5 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Non-Interventional, Observational Study To Evaluate The Antibacterial Therapeutical Options In Febrile Neutropenia Patients
- ClinicalTrials.gov ID
- NCT00945555
- Acronym / sponsor ID
- A1891006
- Conditions
- Febrile Neutropenia
- Keywords
- Antibacterials, Classification of antibacterial agent, Febrile neutropenia, Turkey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Posted 3 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to define and classify antibacterial agents used in Turkey for patients with febrile neutropenia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Drug: Antibacterial agent for the treatment of febrile neutropeniaParticipants with febrile neutropenia who received antibacterial treatment per investigator's judgment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with febrile neutropenia who were planning to take antibacterial treatment.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who are pregnant or considering pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibacterial agent for the treatment of febrile neutropeniaThe antibacterial agent used by the investigators for febrile neutropenia will be determined and classified in the preference order | Drug | All participants |
Primary outcome
Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical
Time frame: Baseline
Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted
Time frame: Baseline
6 secondary outcomes
Mean Body Temperature
Time frame: Baseline, Day 4, Day 7 on Average (till the End of Treatment)
Mean Neutrophil Count
Time frame: Baseline, Day 4, Day 7 on Average (till the End of Treatment)
Percentage of Participants in Whom New Infection Was Determined on Day 4
Time frame: Day 4
Percentage of Participants in Whom New Infection Was Determined at End of Treatment
Time frame: Day 7 on Average (till the End of Treatment)
Percentage Survivors
Time frame: Day 7 on Average (till the End of Treatment)
Percentage of Participants Who Had a Treatment Modification
Time frame: Day 4, Day 7 on Average (till the End of Treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Neutropenia, run by Pfizer at 5 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.