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

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ClinicalTrials.gov Identifier: NCT00913042
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : July 26, 2012
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.


Condition or disease Intervention/treatment
Febrile Neutropenia Post-chemotherapy Other: sample blood

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.

Study Design
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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of New Blood Culture Methods on the Microbiological Documentation of Febrile Neutropenia
Study Start Date : February 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Groups and Cohorts
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Group/Cohort Intervention/treatment
1
febrile neutropenia patient
 Other: sample blood
  • Early culture
  • Bacterial DNA tests in blood


Outcome Measures
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Primary Outcome Measures :
  1. proportion of microbiologically documented infections [ Time Frame: Day 14 from inclusion ]

Secondary Outcome Measures :
  1. clinical status at the end of hospitalisation [ Time Frame: Day 30 from inclusion ]

Biospecimen Retention:   Samples With DNA
bacterial inoculum in the blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Febrile neutropenia post-chemotherapy
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913042


Locations
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France
Hematology Department, Paris 12 University Hospital Henri Mondor
Creteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Cécile Pautas, PH Henri Mondor Hospital
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00913042    
Other Study ID Numbers: CRC 06021
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: July 26, 2012
Last Verified: April 2009
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Febrile neutropenia
Blood culture
Bacteremia
Bacterial DNA testing
Additional relevant MeSH terms:
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Neutropenia
Febrile Neutropenia
Fever
Agranulocytosis
 Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes