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

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.

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Key information

Conditions

Febrile Agranulocytosis Bacteremia Bacterial Infections Bacterial Infections and Mycoses Body Temperature Changes Cytopenia Febrile Neutropenia Fever Hematologic Diseases Hemic and Lymphatic Diseases Infections Inflammation Leukocyte Disorders Leukopenia Neutropenia Pathologic Processes Pathological Conditions, Signs and Symptoms Post-chemotherapy Sepsis Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hematology Department, Paris 12 University Hospital Henri Mondor

Créteil, 94010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sample blood

Other

Early culture
Bacterial DNA tests in blood

Primary outcomes

proportion of microbiologically documented infections

Time frame: Day 14 from inclusion

Secondary outcomes

clinical status at the end of hospitalisation

Time frame: Day 30 from inclusion

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: HEMATOCPLUS

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Jun 3, 2009
Registry last updated: Jul 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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