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 Overview

• Status: Completed
• Conditions: Neutropenia; Febrile; Post-chemotherapy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Creteil, France, 94010
    • Hematology Department, Paris 12 University Hospital Henri Mondor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Febrile neutropenia post-chemotherapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; febrile neutropenia patient	Other: sample blood; Early culture; Bacterial DNA tests in blood

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Cécile Pautas, PH, Henri Mondor University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: June 2, 2009
• First Submitted That Met QC Criteria: June 2, 2009
• First Posted (Estimate): June 3, 2009

Study Record Updates

• Last Update Posted (Estimate): July 26, 2012
• Last Update Submitted That Met QC Criteria: July 25, 2012
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: Bacteremia; Febrile neutropenia; Blood culture; Bacterial DNA testing
• Additional Relevant MeSH Terms: Wounds and Injuries; Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Body Temperature Changes; Heat Stress Disorders; Neutropenia; Hyperthermia; Fever; Febrile Neutropenia
• Other Study ID Numbers: CRC 06021