NCT03217721

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2017

Completed
Last Updated

August 12, 2024

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

July 5, 2017

Last Update Submit

August 9, 2024

Conditions

Neutropenia, Febrile

Outcome Measures

Primary Outcomes (1)

  • Proportion of adequate antibiotic prescription

    Proportion of adequate antibiotic prescription

    Through study completion, an average of 1 month

Secondary Outcomes (1)

  • Mortality of all causes

    ICU, hospital and 28-day mortality

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pilot, exploratory, monocentric, retrospective, observational study

You may qualify if:

  • Sepsis or septic shock at admission or during the stay

You may not qualify if:

  • Minor
  • Pregnancy
  • Opposition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Related Publications (1)

  • 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.

    PMID: 27638133BACKGROUND

MeSH Terms

Conditions

Febrile Neutropenia

Condition Hierarchy (Ancestors)

NeutropeniaAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 14, 2017

Study Start

June 19, 2017

Primary Completion

September 19, 2017

Study Completion

September 19, 2017

Last Updated

August 12, 2024

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)