NCT00913042

Brief Summary

Febrile neutropenia are microbiologically documented in only 30% of the cases, and almost exclusively by blood cultures. The reasons for this low documentation are likely multiple: (1) some of these fevers are of non-infectious origin. (2) The bacterial inoculum present in the blood may be low and consequently undetectable by conventional blood cultures. The primary objective of the study is to assess new blood culture procedures and technics, in order to improve the diagnostic yield of blood cultures during febrile neutropenic episodes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
Last Updated

July 26, 2012

Status Verified

April 1, 2009

Enrollment Period

1.2 years

First QC Date

June 2, 2009

Last Update Submit

July 25, 2012

Conditions

FebrileNeutropeniaPost-chemotherapy

Keywords

Febrile neutropeniaBlood cultureBacteremiaBacterial DNA testing

Outcome Measures

Primary Outcomes (1)

  • proportion of microbiologically documented infections

    Day 14 from inclusion

Secondary Outcomes (1)

  • clinical status at the end of hospitalisation

    Day 30 from inclusion

Study Arms (1)

1

febrile neutropenia patient

Other: sample blood

Interventions

sample bloodOTHER

* Early culture * Bacterial DNA tests in blood

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Febrile neutropenia post-chemotherapy

You may qualify if:

  • age \> 18 y
  • first episode of febrile neutropenia during a given neutropenic phase
  • PMN \< 500/mm3, chemotherapy-induced
  • fever \> 38°C twice, or \< 38°3C once
  • signed informed consent

You may not qualify if:

  • \- patient already receiving empirical or therapeutic antibacterial after their first episode of febrile neutropenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematology Department, Paris 12 University Hospital Henri Mondor

Créteil, 94010, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

bacterial inoculum in the blood

MeSH Terms

Conditions

FeverNeutropeniaFebrile NeutropeniaBacteremia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersBacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic Processes

Study Officials

  • Cécile Pautas, PH

    Henri Mondor University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 3, 2009

Study Start

February 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

July 26, 2012

Record last verified: 2009-04

Locations

FR(1)