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CompletedNCT00913042HEMATOCPLUSUpdated Jul 26, 2012

Assessment of New Blood Culture Methods on the Microbiological Documentation of Febrile Neutropenia

An observational study in Febrile, Neutropenia and Post-chemotherapy, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-26.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Evaluation criteria are 1) proportion of microbiologically documented infections 2) time elapsed from bed side sampling to microbiological diagnostic, in case of positive sample.

The assessed procedures included a large volume of blood, an early incubation made possible by the availability of a culture device in the hematology department, an early warning in case of positive blood culture, bacterial DNA detection in blood, and an early identification of the positive strains and their resistance profile.

We hypothesize that the combination of these different procedures will improve the proportion of microbiologically blood culture from 30 to 45%. One hundred and 20 episodes of febrile neutropenia are necessary to achieve this goal.

02

Conditions studied

  • Febrile
  • Neutropenia
  • Post-chemotherapy

Keywords

  • Febrile neutropenia
  • Blood culture
  • Bacteremia
  • Bacterial DNA testing
03

In context

Neutropenia

396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.

This study's enrollment of 120 is below the median of 175 across 96 observational studies indexed under Neutropenia.

Browse Neutropenia studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,506 studies on the registry; 1,007 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Febrile neutropenia post-chemotherapy

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • patient already receiving empirical or therapeutic antibacterial after their first episode of febrile neutropenia
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
120 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1

    febrile neutropenia patient

    Other: sample blood

Interventions

  • Othersample blood

    * Early culture * Bacterial DNA tests in blood

06

What researchers measure

Primary outcomes

  1. proportion of microbiologically documented infections

    Time frame: Day 14 from inclusion

Secondary outcomes

  1. clinical status at the end of hospitalisation

    Time frame: Day 30 from inclusion

07

Study locations

1 site
  • Hematology Department, Paris 12 University Hospital Henri Mondor
    Creteil, 94010, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00913042
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jun 3, 2009
Start date
Feb 2008
Primary completion
Apr 2009
Completion
Apr 2009
Last update
Jul 26, 2012

Study contacts

Cécile Pautas, PH
principal investigator · Henri Mondor University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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