REANEUF: Antibiotics Management of Septic Neutropenic Patients in the Intensive Care Unit

• Sponsor: University Hospital, Brest (Other)
• Overall Status: Completed
• CT.gov ID: NCT03217721
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 3
• Patients Per Site Per Month: 33.1

Study Details

Study Description

Brief 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. The recommendations published in 2016 were formulated to homogenize the clinical practices to improve the survival.

Condition or Disease	Intervention/Treatment	Phase
Neutropenia, Febrile

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

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Antibiotics Management of Septic Neutropenic Patients in the Intensive Care Unit : New Recommendations do They Change Our Clinical Practice ?
• Actual Study Start Date: Jun 19, 2017
• Actual Primary Completion Date: Sep 19, 2017
• Actual Study Completion Date: Sep 19, 2017

Outcome Measures

Primary Outcome Measures

1. Proportion of adequate antibiotic prescription [Through study completion, an average of 1 month]

   Proportion of adequate antibiotic prescription

Secondary Outcome Measures

1. Mortality of all causes [ICU, hospital and 28-day mortality]

   Mortality of all causes

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Sepsis or septic shock at admission or during the stay

Exclusion Criteria:

• Minor

• Pregnancy

• Opposition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU de Brest	Brest		France	29609

Sponsors and Collaborators

• University Hospital, Brest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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. Review.

• Responsible Party: University Hospital, Brest
• ClinicalTrials.gov Identifier: NCT03217721
• Other Study ID Numbers: 29BRC17.0092
• First Posted: Jul 14, 2017
• Last Update Posted: Oct 2, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neutropenia; Febrile Neutropenia

Study Results

No Results Posted as of Oct 2, 2017