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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00913042
First received: June 2, 2009
Last updated: July 25, 2012
Last verified: April 2009
  Purpose

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 Intervention
Febrile
Neutropenia
Post-chemotherapy
Other: sample blood

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of New Blood Culture Methods on the Microbiological Documentation of Febrile Neutropenia

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • proportion of microbiologically documented infections [ Time Frame: Day 14 from inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 120
Study Start Date: February 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
febrile neutropenia patient
Other: sample blood
  • Early culture
  • Bacterial DNA tests in blood
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913042

Locations
France
Hematology Department, Paris 12 University Hospital Henri Mondor
Creteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Cécile Pautas, PH Henri Mondor Hospital
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00913042     History of Changes
Other Study ID Numbers: CRC 06021
Study First Received: June 2, 2009
Last Updated: July 25, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Febrile neutropenia
Blood culture
Bacteremia
Bacterial DNA testing

Additional relevant MeSH terms:
Neutropenia
Fever
Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014