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

Not Applicable

Terminated

• Conditions: Febrile Neutropenia, Drug-Induced
• Interventions: Diagnostic Test: Value of ProCalcitonin

• Registration Number: NCT03182465
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-09
• Study Start: 2017-10-04
• Primary Completion: 2022-12-25
• Study Completion: 2022-12-25
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
the predictive value of ProCalcitonin	Value of ProCalcitonin	Patients with solid tumors admitted at the emergency care presenting a febrile neutropenia due to chemotherapy

Primary Outcome Measures

Name	Time	Method
Minimum level of ProCalcitonin	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

Secondary Outcome Measures

Name	Time	Method
Compare the MASCC score and the Anh & al score	up to 1 week	Based on the chareteristics of the two scores

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium