Assessment of New Blood Culture Methods on the Microbiological Documentation of Febrile Neutropenia (HEMATOCPLUS)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Assessment of New Blood Culture Methods on the Microbiological Documentation of Febrile Neutropenia|
- proportion of microbiologically documented infections [ Time Frame: Day 14 from inclusion ] [ Designated as safety issue: No ]
- clinical status at the end of hospitalisation [ Time Frame: Day 30 from inclusion ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
bacterial inoculum in the blood
|Study Start Date:||February 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
febrile neutropenia patient
Other: sample blood
Other Name: sample blood
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913042
|Hematology Department, Paris 12 University Hospital Henri Mondor|
|Creteil, France, 94010|
|Principal Investigator:||Cécile Pautas, PH||Henri Mondor Hospital|