Bloodstream InfectionNCT04910698
Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia
An observational study of Bloodstream Infection and Acute Myeloid Leukemia, run by Poitiers University Hospital at 1 site in France.
Trial summary
There is no specific recommendation about antimicrobial treatment length for documented infections in chemotherapy induced febrile neutropenia. The aim of this study was to compare long versus short antibiotic course for bloodstream infection treatment in acute myeloid leukemia patients during febrile neutropenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bloodstream Infection, Acute Myeloid Leukemia, Febrile Neutropenia
- What is being tested?
- Antibiotic
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Jun 2020
- Phase
- Observational
- 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
Study population: All bloodstream infection episodes occuring in patients suffering from febrile neutropenia during acute myeloid leukemia between January 2017 and December 2019 in University Hospital of Poitiers were included.
Who may be able to join
- Acute myeloid leukemia
- chemo-induced febrile neutropenia
- Bloodstream infection
Who cannot join
- lack of data
- endovascular infections
- surgical treatment required
- central nervous system infections
- antibiotic treatment < 4 days
- death before the end of antibiotic treatment
Show all 9Show fewer
- unappropriated antibiotic treatment at 48h
- relapses of bloodstream infection episodes already included
- hematopoietic stem cell transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia: a Retrospective Comparative Study
There is no specific recommendation about antimicrobial treatment length for documented infections in chemotherapy induced febrile neutropenia. The aim of this study was to compare long versus short antibiotic course for bloodstream infection treatment in acute myeloid leukemia patients during febrile neutropenia. This monocentric retrospective comparative study included all consecutive bloodstream infection episodes among acute myeloid leukemia patients with febrile neutropenia for 3 years (2017-2019). Episodes were classified regarding the length of antibiotic treatment, considered as short course if the treatment lasted ≤7 days, except for nonfermenting bacteria and Staphylococcus aureus or lugdunensis for which the threshold was ≤10 days and ≤14 days, respectively. The primary outcome was the number of bloodstream infection relapses in both groups within 30 days of antibiotic discontinuation.
- Being tested
- Antibiotic
- Keywords
- antibiotic short course, appropriate use of antibiotics
- Medical subject headings
- Sepsis, Leukemia, Myeloid, Acute, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
Antibiotic duration of treatment defined if the patient belonged to long course or short course group.
| Study group | Role | What they receive |
|---|---|---|
| Short course treatment | Patients who received antibiotic for 7 or less days, except for nonfermenting bacteria and Staphylococcus aureus or lugdunensis for which the threshold was 10 days and 14 days, respectively. Receives: Drug: Antibiotic | |
| Long course treatment | Patients who received antibiotic for more than 7 days, except for nonfermenting bacteria and Staphylococcus aureus or lugdunensis for which the threshold was 10 days and 14 days, respectively. Receives: Drug: Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bloodstream infection relapses
The primary outcome was to compare the number of bloodstream infection relapses in both groups within 30 days of antibiotic discontinuation.
Measured: within 30 days of antibiotic discontinuation
Secondary outcomes (3)
Mortality
Comparison of mortality rate within 30 days of antibiotic discontinuation
Measured: within 30 days of antibiotic discontinuation
Epidemiology of bacteria
Distribution of bacteria responsible for bloodstream infection
Measured: at baseline
Risk factors for relapses
Analyse of risk factors for bloodstream infection relapses
Measured: within 30 days of antibiotic discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start1 Jan 2020
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bloodstream InfectionStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- France Cazenave-Roblot, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910698
- Sponsor's protocol ID
- Antibioshort neutropenia
- Status last verified
- May 2021
- First submitted
- 27 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia: a Retrospective Comparative Study
- ClinicalTrials.gov ID
- NCT04910698
- Acronym / sponsor ID
- Antibioshort neutropenia
- Keywords
- antibiotic short course, appropriate use of antibiotics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 2 Jun 2021 (actual)
- 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.
There is no specific recommendation about antimicrobial treatment length for documented infections in chemotherapy induced febrile neutropenia. The aim of this study was to compare long versus short antibiotic course for bloodstream infection treatment in acute myeloid leukemia patients during febrile neutropenia. This monocentric retrospective comparative study included all consecutive bloodstream infection episodes among acute myeloid leukemia patients with febrile neutropenia for 3 years (2017-2019). Episodes were classified regarding the length of antibiotic treatment, considered as short course if the treatment lasted ≤7 days, except for nonfermenting bacteria and Staphylococcus aureus or lugdunensis for which the threshold was ≤10 days and ≤14 days, respectively. The primary outcome was the number of bloodstream infection relapses in both groups within 30 days of antibiotic discontinuation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short course treatment | – | Drug: AntibioticPatients who received antibiotic for 7 or less days, except for nonfermenting bacteria and Staphylococcus aureus or lugdunensis for which the threshold was 10 days and 14 days, respectively. |
| Long course treatment | – | Drug: AntibioticPatients who received antibiotic for more than 7 days, except for nonfermenting bacteria and Staphylococcus aureus or lugdunensis for which the threshold was 10 days and 14 days, respectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All bloodstream infection episodes occuring in patients suffering from febrile neutropenia during acute myeloid leukemia between January 2017 and December 2019 in University Hospital of Poitiers were included.
Key inclusion criteria (3 listed)
- Acute myeloid leukemia
- chemo-induced febrile neutropenia
- Bloodstream infection
Key exclusion criteria (9 listed)
- lack of data
- endovascular infections
- surgical treatment required
- central nervous system infections
- antibiotic treatment < 4 days
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 |
|---|---|---|
| AntibioticAntibiotic duration of treatment defined if the patient belonged to long course or short course group. | Drug | Long course treatment, Short course treatment |
Primary outcome
Bloodstream infection relapses
Time frame: within 30 days of antibiotic discontinuation
The primary outcome was to compare the number of bloodstream infection relapses in both groups within 30 days of antibiotic discontinuation.
3 secondary outcomes
Mortality
Time frame: within 30 days of antibiotic discontinuation
Epidemiology of bacteria
Time frame: at baseline
Risk factors for relapses
Time frame: within 30 days of antibiotic discontinuation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
France Cazenave-Roblot study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bloodstream Infection and Acute Myeloid Leukemia, run by Poitiers University Hospital at 1 site in France.
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 3 inclusion and 9 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 2 Jun 2021. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bloodstream infection relapses (time frame: within 30 days of antibiotic discontinuation). 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 2 Jun 2021.