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Predictive Value of ProCalcitonin for the Detection of Bacteraemia in Patients Presenting to the Emergency Department for Low Risk Chemo-induced Febrile Neutropenia (CALIF)

Primary Purpose

Febrile Neutropenia, Drug-Induced

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Value of ProCalcitonin
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Febrile Neutropenia, Drug-Induced

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • more than 18 years old
  • Patients with solid malignant tumor treated by chemotherapy (neoadjuvant, concomittant, adjuvant or metastatic)
  • Febrile neutropenia chemo-induced (fever > 38°C, neutrophils < 500 /microliter or nadir < 500 /microliter)
  • Patients non hospitalized at the event (when he presented febrile neutropenia)
  • Informed consent signed

Exclusion Criteria:

  • Thyroid medullar carcinoma
  • Patient not able to understand protocol (mental retardation, psychiatric disorders, .... )

Sites / Locations

  • Cliniques universitaires Saint-LucRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

the predictive value of ProCalcitonin

Arm Description

Patients with solid tumors admitted at the emergency care presenting a febrile neutropenia due to chemotherapy

Outcomes

Primary Outcome Measures

Minimum level of ProCalcitonin
Bacteria detection will be determined by the optimal value of ProCalcitonin in patients with solid tumors treated by chemotherapy and at low MASCC risk

Secondary Outcome Measures

Compare the MASCC score and the Anh & al score
Based on the chareteristics of the two scores

Full Information

First Posted
June 8, 2017
Last Updated
March 18, 2021
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT03182465
Brief Title
Predictive Value of ProCalcitonin for the Detection of Bacteraemia in Patients Presenting to the Emergency Department for Low Risk Chemo-induced Febrile Neutropenia
Acronym
CALIF
Official Title
Predictive Value of ProCalcitonin for the Detection of Bacteraemia in Patients Presenting to the Emergency Department for Low Risk Chemo-induced Febrile Neutropenia According to the MASCC Score: a Prospective, Monocentric Observational Study (CALIF)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2017 (Actual)
Primary Completion Date
December 25, 2022 (Anticipated)
Study Completion Date
December 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
CALIF study is a monocentric observational study which aim is to analyse the value of adding procalcitonin (PCT, a pre-hormon increased in bacterial infection and septicaemia) in the management of chemo-induced febrile neutropenia occurring in patient with solid tumour. Febrile neutropenia will be managed according to international guidelines. PCT will be dosed at initial presentation. Primary objective is to determine the optimal value of PCT for the detection of septicaemia in low risk (according to MASCC score). The investigators plan also to compare two risk stratification scores: the validated MASCC score and a recently developed score which includes PCT and other more objective items.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Febrile Neutropenia, Drug-Induced

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the predictive value of ProCalcitonin
Arm Type
Other
Arm Description
Patients with solid tumors admitted at the emergency care presenting a febrile neutropenia due to chemotherapy
Intervention Type
Diagnostic Test
Intervention Name(s)
Value of ProCalcitonin
Intervention Description
The predictive value of ProCalcitonin in patients with solid tumors presenting a febrile neutropenia due to chemotherapy at emergency unit will be a factor to detect the level of bacteria.
Primary Outcome Measure Information:
Title
Minimum level of ProCalcitonin
Description
Bacteria detection will be determined by the optimal value of ProCalcitonin in patients with solid tumors treated by chemotherapy and at low MASCC risk
Time Frame
at day 0
Secondary Outcome Measure Information:
Title
Compare the MASCC score and the Anh & al score
Description
Based on the chareteristics of the two scores
Time Frame
up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: more than 18 years old Patients with solid malignant tumor treated by chemotherapy (neoadjuvant, concomittant, adjuvant or metastatic) Febrile neutropenia chemo-induced (fever > 38°C, neutrophils < 500 /microliter or nadir < 500 /microliter) Patients non hospitalized at the event (when he presented febrile neutropenia) Informed consent signed Exclusion Criteria: Thyroid medullar carcinoma Patient not able to understand protocol (mental retardation, psychiatric disorders, .... )
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Pascal Machiels, MD, PhD
Phone
00322764
Ext
5457
Email
jean-pascal.machiels@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Gaetan Catala, MD
Phone
00322764
Ext
4231
Email
gaetan.catala@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jean-Pascal Machiels, MD, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pascal Machiels, MD, PhD
Phone
00322764
Ext
5457
Email
jean-pascal.machiels@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Gaetan Catala, MD
Phone
00322764
Ext
4231
Email
gaetan.catala@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Andrea Penazola, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
There is no plan to share IPD at this moment

Learn more about this trial

Predictive Value of ProCalcitonin for the Detection of Bacteraemia in Patients Presenting to the Emergency Department for Low Risk Chemo-induced Febrile Neutropenia

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