MedDataX Logo

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

NCT ID: NCT00913042

Last Updated: 2012-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Febrile Neutropenia Post-chemotherapy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Febrile neutropenia Blood culture Bacteremia Bacterial DNA testing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

febrile neutropenia patient

sample blood

Intervention Type OTHER

* Early culture
* Bacterial DNA tests in blood

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sample blood

* Early culture
* Bacterial DNA tests in blood

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cécile Pautas, PH

Role: PRINCIPAL_INVESTIGATOR

Henri Mondor University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hematology Department, Paris 12 University Hospital Henri Mondor

Créteil, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRC 06021

Identifier Type: -

Identifier Source: org_study_id