Neutropenia, FebrileREANEUFNCT03217721
Antibiotics Management of Septic Neutropenic Patients in the Intensive Care Unit
An observational study of Neutropenia, Febrile, run by University Hospital, Brest at 1 site in France.
Trial summary
Neutropenia, defined by an absolute count of polymorphonuclear neutrophils less than <1500/mm3, exposes patients to infectious complications that can lead to sepsis or septic shock. The mortality risk is higher risk. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neutropenia, Febrile
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2017to 19 Sep 2017
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Pilot, exploratory, monocentric, retrospective, observational study
Who may be able to join
- Sepsis or septic shock at admission or during the stay
Who cannot join
- Minor
- Pregnancy
- Opposition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antibiotics Management of Septic Neutropenic Patients in the Intensive Care Unit : New Recommendations do They Change Our Clinical Practice ?
Neutropenia, defined by an absolute count of polymorphonuclear neutrophils less than <1500/mm3, exposes patients to infectious complications that can lead to sepsis or septic shock. The mortality risk is higher risk. The recommendations published in 2016 were formulated to homogenize the clinical practices to improve the survival.
Read the detailed description
We evaluate the adequacy antibiotics prescriptions in febrile neutropenia with suspected infection and evaluate factors influencing adequacy therapy and mortality consequence.
- Conditions
- Neutropenia, Febrile
- Medical subject headings
- Febrile Neutropenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of adequate antibiotic prescription
Proportion of adequate antibiotic prescription
Measured: Through study completion, an average of 1 month
Secondary outcomes (1)
Mortality of all causes
Mortality of all causes
Measured: ICU, hospital and 28-day mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start19 Jun 2017
- Primary completion19 Sep 2017
- Study completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neutropenia, FebrileStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217721
- Sponsor's protocol ID
- 29BRC17.0092 - REANEUF
- Acronym
- REANEUF
- Status last verified
- Jul 2017
- First submitted
- 5 Jul 2017
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schnell D, Azoulay E, Benoit D, Clouzeau B, Demaret P, Ducassou S, Frange P, Lafaurie M, Legrand M, Meert AP, Mokart D, Naudin J, Pene F, Rabbat A, Raffoux E, Ribaud P, Richard JC, Vincent F, Zahar JR, Darmon M. Management of neutropenic patients in the intensive care unit (NEWBORNS EXCLUDED) recommendations from an expert panel from the French Intensive Care Society (SRLF) with the French Group for Pediatric Intensive Care Emergencies (GFRUP), the French Society of Anesthesia and Intensive Care (SFAR), the French Society of Hematology (SFH), the French Society for Hospital Hygiene (SF2H), and the French Infectious Diseases Society (SPILF). Ann Intensive Care. 2016 Dec;6(1):90. doi: 10.1186/s13613-016-0189-6. Epub 2016 Sep 15.
PubMed 27638133
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotics Management of Septic Neutropenic Patients in the Intensive Care Unit : New Recommendations do They Change Our Clinical Practice ?
- ClinicalTrials.gov ID
- NCT03217721
- Acronym / sponsor ID
- REANEUF / 29BRC17.0092 - REANEUF
- Conditions
- Neutropenia, Febrile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 19 Sep 2017 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 14 Jul 2017 (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.
Neutropenia, defined by an absolute count of polymorphonuclear neutrophils less than <1500/mm3, exposes patients to infectious complications that can lead to sepsis or septic shock. The mortality risk is higher risk. The recommendations published in 2016 were formulated to homogenize the clinical practices to improve the survival.
Detailed description
We evaluate the adequacy antibiotics prescriptions in febrile neutropenia with suspected infection and evaluate factors influencing adequacy therapy and mortality consequence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Pilot, exploratory, monocentric, retrospective, observational study
Key inclusion criteria (1 listed)
- Sepsis or septic shock at admission or during the stay
Key exclusion criteria (3 listed)
- Minor
- Pregnancy
- Opposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of adequate antibiotic prescription
Time frame: Through study completion, an average of 1 month
Proportion of adequate antibiotic prescription
1 secondary outcome
Mortality of all causes
Time frame: ICU, hospital and 28-day mortality
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 12 Aug 2024.
- Background: PubMed 27638133Schnell D, Azoulay E, Benoit D, Clouzeau B, Demaret P, Ducassou S, Frange P, Lafaurie M, Legrand M, Meert AP, Mokart D, Naudin J, Pene F, Rabbat A, Raffoux E, Ribaud P, Richard JC, Vincent F, Zahar JR, Darmon M. Management of neutropenic patients in the intensive care unit (NEWBORNS EXCLUDED) recommendations from an expert panel from the French Intensive Care Society (SRLF) with the French Group for Pediatric Intensive Care Emergencies (GFRUP), the French Society of Anesthesia and Intensive Care (SFAR), the French Society of Hematology (SFH), the French Society for Hospital Hygiene (SF2H), and the French Infectious Diseases Society (SPILF). Ann Intensive Care. 2016 Dec;6(1):90. doi: 10.1186/s13613-016-0189-6. Epub 2016 Sep 15.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neutropenia, Febrile, run by University Hospital, Brest 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 1 inclusion and 3 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 12 Aug 2024. 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?
Proportion of adequate antibiotic prescription (time frame: Through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03217721, which also lists 1 linked publication.
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 12 Aug 2024.