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

December 8, 2023 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques universitaires Saint-Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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, .... )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: the predictive value of ProCalcitonin
Patients with solid tumors admitted at the emergency care presenting a febrile neutropenia due to chemotherapy
Diagnostic test: Value of ProCalcitonin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimum level of ProCalcitonin
Time Frame: at day 0
Bacteria detection will be determined by the optimal value of ProCalcitonin in patients with solid tumors treated by chemotherapy and at low MASCC risk
at day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the MASCC score and the Anh & al score
Time Frame: up to 1 week
Based on the chareteristics of the two scores
up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Jean-Pascal Machiels, MD, PhD, Cliniques universitaires Saint-Luc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2017

Primary Completion (Actual)

December 25, 2022

Study Completion (Actual)

December 25, 2022

Study Registration Dates

First Submitted

June 8, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (Actual)

June 9, 2017

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/24FEV/112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

There is no plan to share IPD at this moment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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