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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00913042
Acronym
HEMATOCPLUS
Enrollment
120
Registered
2009-06-03
Start date
2008-02-29
Completion date
2009-04-30
Last updated
2012-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile, Neutropenia, Post-chemotherapy

Keywords

Febrile neutropenia, Blood culture, Bacteremia, Bacterial DNA testing

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.

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.

Interventions

* Early culture * Bacterial DNA tests in blood

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frame
proportion of microbiologically documented infectionsDay 14 from inclusion

Secondary

MeasureTime frame
clinical status at the end of hospitalisationDay 30 from inclusion

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026