- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03217721
Antibiotics Management of Septic Neutropenic Patients in the Intensive Care Unit (REANEUF)
September 29, 2017 updated by: University Hospital, Brest
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.
Study Overview
Status
Completed
Conditions
Detailed Description
We evaluate the adequacy antibiotics prescriptions in febrile neutropenia with suspected infection and evaluate factors influencing adequacy therapy and mortality consequence.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Brest, France, 29609
- CHRU de Brest
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pilot, exploratory, monocentric, retrospective, observational study
Description
Inclusion Criteria:
- Sepsis or septic shock at admission or during the stay
Exclusion Criteria:
- Minor
- Pregnancy
- Opposition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of adequate antibiotic prescription
Time Frame: Through study completion, an average of 1 month
|
Proportion of adequate antibiotic prescription
|
Through study completion, an average of 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality of all causes
Time Frame: ICU, hospital and 28-day mortality
|
Mortality of all causes
|
ICU, hospital and 28-day mortality
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 19, 2017
Primary Completion (Actual)
September 19, 2017
Study Completion (Actual)
September 19, 2017
Study Registration Dates
First Submitted
July 5, 2017
First Submitted That Met QC Criteria
July 12, 2017
First Posted (Actual)
July 14, 2017
Study Record Updates
Last Update Posted (Actual)
October 2, 2017
Last Update Submitted That Met QC Criteria
September 29, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29BRC17.0092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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