Febrile NeutropeniaNCT01450241
Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia
A study testing Early antibiotic discontinuation and Usual practice in people with Febrile Neutropenia, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether short-course antibiotic therapy is safe and effective for the treatment of cancer 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?
- Early antibiotic discontinuation and Usual practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Adults >18 years providing signed informed consent
- Patients with solid tumors, lymphoma, multiple myeloma or chronic lymphocytic leukemia, regardless of disease status or previous chemotherapy
- Documented febrile neutropenia
- No clinically or microbiologically documented infection after 72 hours
Who cannot join
- Previous enrollment in this study
- Concurrent participation in another interventional trial
- Severe sepsis or septic shock
- Acute leukemia, autologous or allogeneic hematopoietic stem-cell transplantation
- Diarrhea suspected by treating physician to be Irinotecan induced
- Any antibiotic treatment for >48h in the last week before enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia: Randomized-controlled Trial
The purpose of this study is to determine whether short-course antibiotic therapy is safe and effective for the treatment of cancer patients with febrile neutropenia.
Read the detailed description
Febrile neutropenia remains a major cause of morbidity in solid cancer patients. There is an unresolved question regarding the appropriate duration of antibiotic treatment for patients with febrile neutropenia of unknown origin. Current guidelines recommend at least seven days of antibiotic treatment. Several studies have demonstrated the safety of early antibiotic discontinuation in patients with febrile neutropenia. We plan an open label randomized controlled trial to compare early antibiotic discontinuation to the accepted prolonged antibiotic treatment protocol
- Conditions
- Febrile Neutropenia
- Being tested
- Early antibiotic discontinuation, Usual practice
- Keywords
- Febrile neutropenia, Unexplained fever, Duration, Short-term antibiotic treatment
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early antibiotic discontinuationOther
Antibiotic treatment for unexplained febrile neutropenia stopped after 72 hours, regardless of fever
Usual practiceOther
Continued antibiotic treatment as accepted by guidelines for febrile neutropenia
| Study group | Role | What they receive |
|---|---|---|
| Early antibiotic discontinuation | Experimental | Antibiotic treatment stopped after 72h, regardless of fever.The antibiotics used will be piperacillin tazobactam for high-risk patients and amoxycillin-clavulanate + ciprlofloxacin for low-risk patients (defined by MASCC scoring system). Alternatives in case of penicillin allergy will be ceftazidine and levofloxacin, respectively. Receives: Other: Early antibiotic discontinuation |
| Usual practice | Other | Antibiotic treatment continued according to accepted guidelines and current clinical practice. The antibiotics used will be piperacillin tazobactam for high-risk patients and amoxycillin-clavulanate + ciprlofloxacin for low-risk patients (defined by MASCC scoring system). Alternatives in case of penicillin allergy will be ceftazidine and levofloxacin, respectively. Receives: Other: Usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever
Composite outcome of all-cause mortality, severe infection (defined as clinically or microbiologically documented infection with systemic inflammatory response syndrome (SIRS)), severe diarrhea (>=3 daily for >=2 days) or fever (>38)
Measured: After day 7 from randomization until day 30
Total febrile or antibiotic days
Total febrile or antibiotic days from the day of randomization until day 30, defined as a day with one or more temperature measurement >38.0°C or a day on which antibiotic treatment was prescribed for any reason other than prophylaxis
Measured: From the day of randomization until day 30
Secondary outcomes (10)
Clinically and/or microbiologically documented infections
Clinically and/or microbiologically documented infections within 30 days of randomization. We will use the 2008 CDC/NHSN surveillance definitions of health-care associated infections for bacterial infections (including Clostridium difficile) and the 2008 revised definitions for invasive fungal infections.
Measured: 30 days
Total in-hospital days
Total in-hospital days from the day of randomization up to day 30
Measured: 30 days
Re-admission
Rates of re-admission for any reason other than planned chemotherapy.
Measured: 30 days
Antibiotic treatment
Patients receiving antibiotic treatment after day 7 from randomization until day 30
Measured: After day 7 from randomization until day 30
Antifungal treatment
Institution of antifungal treatment
Measured: 30 days
Duration of intravenous antibiotic treatment
Duration of intravenous antibiotic treatment
Measured: 30 days
Duration of neutropenia
Duration of neutropenia
Measured: 30 days
Development of resistance
Development of resistance, defined as clinical isolates resistant to antibiotics previously used in the febrile episode. Surveillance sampling will not be conducted.
Measured: 30 days
All-cause mortality
All-cause mortality
Measured: 30 days
Infection-related mortality
Cause of death adjudicated by the trial's safety committee
Measured: 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2014 (estimated)
- Study completionJan 2015 (estimated)
Why it stopped: slow recruitment, no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, leibovici leonard, Rabin Medical Center
- Investigators
- Mical Paul, MD, Principal investigator, Rabin Medical CenterLeonard Leibovici, Prof, Principal investigator, Rabin Medical CenterDafna Yahav, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450241
- Sponsor's protocol ID
- RabinMC6249
- Status last verified
- Jun 2013
- First submitted
- 17 Sep 2011
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia: Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT01450241
- Acronym / sponsor ID
- RabinMC6249
- Conditions
- Febrile Neutropenia
- Keywords
- Febrile neutropenia, Unexplained fever, Duration, Short-term antibiotic treatment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: slow recruitment, no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 12 Oct 2011 (estimated)
- Results
- Not posted in the source record
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 is to determine whether short-course antibiotic therapy is safe and effective for the treatment of cancer patients with febrile neutropenia.
Detailed description
Febrile neutropenia remains a major cause of morbidity in solid cancer patients. There is an unresolved question regarding the appropriate duration of antibiotic treatment for patients with febrile neutropenia of unknown origin. Current guidelines recommend at least seven days of antibiotic treatment. Several studies have demonstrated the safety of early antibiotic discontinuation in patients with febrile neutropenia. We plan an open label randomized controlled trial to compare early antibiotic discontinuation to the accepted prolonged antibiotic treatment protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early antibiotic discontinuation | Experimental | Other: Early antibiotic discontinuationAntibiotic treatment stopped after 72h, regardless of fever.The antibiotics used will be piperacillin tazobactam for high-risk patients and amoxycillin-clavulanate + ciprlofloxacin for low-risk patients (defined by MASCC scoring system). Alternatives in case of penicillin allergy will be ceftazidine and levofloxacin, respectively. |
| Usual practice | Other | Other: Usual practiceAntibiotic treatment continued according to accepted guidelines and current clinical practice. The antibiotics used will be piperacillin tazobactam for high-risk patients and amoxycillin-clavulanate + ciprlofloxacin for low-risk patients (defined by MASCC scoring system). Alternatives in case of penicillin allergy will be ceftazidine and levofloxacin, respectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults >18 years providing signed informed consent
- Patients with solid tumors, lymphoma, multiple myeloma or chronic lymphocytic leukemia, regardless of disease status or previous chemotherapy
- Documented febrile neutropenia
- No clinically or microbiologically documented infection after 72 hours
Key exclusion criteria (6 listed)
- Previous enrollment in this study
- Concurrent participation in another interventional trial
- Severe sepsis or septic shock
- Acute leukemia, autologous or allogeneic hematopoietic stem-cell transplantation
- Diarrhea suspected by treating physician to be Irinotecan induced
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 |
|---|---|---|
| Early antibiotic discontinuationAntibiotic treatment for unexplained febrile neutropenia stopped after 72 hours, regardless of fever | Other | Early antibiotic discontinuation |
| Usual practiceContinued antibiotic treatment as accepted by guidelines for febrile neutropenia | Other | Usual practice |
Primary outcome
Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever
Time frame: After day 7 from randomization until day 30
Composite outcome of all-cause mortality, severe infection (defined as clinically or microbiologically documented infection with systemic inflammatory response syndrome (SIRS)), severe diarrhea (>=3 daily for >=2 days) or fever (>38)
Total febrile or antibiotic days
Time frame: From the day of randomization until day 30
Total febrile or antibiotic days from the day of randomization until day 30, defined as a day with one or more temperature measurement >38.0°C or a day on which antibiotic treatment was prescribed for any reason other than prophylaxis
10 secondary outcomes
Clinically and/or microbiologically documented infections
Time frame: 30 days
Total in-hospital days
Time frame: 30 days
Re-admission
Time frame: 30 days
Antibiotic treatment
Time frame: After day 7 from randomization until day 30
Antifungal treatment
Time frame: 30 days
Duration of intravenous antibiotic treatment
Time frame: 30 days
Duration of neutropenia
Time frame: 30 days
Development of resistance
Time frame: 30 days
All-cause mortality
Time frame: 30 days
Infection-related mortality
Time frame: 30 days after randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
Related trials for Febrile Neutropenia
RecruitingPhase 4
Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance
Febrile Neutropenia
Not yet recruiting
Diagnostic Accuracy, Clinical Utility and Implementation of Point-of-Care Absolute Neutrophil Count in Suspected Neutropenic Fever (DUCATIS) - Diagnostic Accuracy (S1)
Suspected Neutropenic Fever, Confirmed Neutropenic Fever
RecruitingObservational study
Mecapegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Advanced Breast Cancer
Breast Cancer, Chemotherapy-induced Neutropenia
Not yet recruiting
Impact of a Telemonitoring Device on the Occurever at Home in Children at Risk of Chemotherapy-Induced Neutropenia
Oncopediatrics, Febrile Neutropenia
Recruiting
Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients
Pediatric Oncology Patients With Risk for Infections
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.
Mical Paul, MD principal investigator
Rabin Medical Center
Leonard Leibovici, Prof principal investigator
Rabin Medical Center
Dafna Yahav, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early antibiotic discontinuation and Usual practice in people with Febrile Neutropenia, run by Rabin Medical Center at 1 site in Israel.
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 6 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: withdrawn, as of the sponsor's last update on 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever (time frame: After day 7 from randomization until day 30). 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 7 Jun 2013.