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

Study Overview
=================
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.

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

Conditions
-----------------
Febrile, Neutropenia, Post-chemotherapy

Intervention / Treatment
-----------------
* Other: sample blood


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>febrile neutropenia patient | Other: sample blood<br>* Early culture Bacterial DNA tests in blood<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of microbiologically documented infections |  | Day 14 from inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical status at the end of hospitalisation |  | Day 30 from inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Febrile neutropenia, Blood culture, Bacteremia, Bacterial DNA testing