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

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Post-chemotherapy
Febrile
Neutropenia

Treatments

Other: sample blood

Study type

Observational

Funder types

Other

Identifiers

NCT00913042
CRC 06021

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

1
Description:
febrile neutropenia patient
Treatment:
Other: sample blood

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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