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

Neutropenia Clinical Trial

— HEMATOCPLUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913042
• Other study ID #: CRC 06021
• Status: Completed
• Phase: N/A
• First received: June 2, 2009
• Last updated: July 25, 2012
• Start date: February 2008
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Febrile
• Febrile Neutropenia
• Fever
• Neutropenia
• Post-chemotherapy

Intervention

Other:
• sample blood
Early culture Bacterial DNA tests in blood

Locations

Country	Name	City	State
France	Hematology Department, Paris 12 University Hospital Henri Mondor	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of microbiologically documented infections		Day 14 from inclusion	No
Secondary	clinical status at the end of hospitalisation		Day 30 from inclusion	No