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

NCT03182465 | Terminated

• 1 other identifier: 2017/24FEV/112
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Febrile Neutropenia, Drug-Induced

Outcome Measures

Primary Outcomes (1)

• 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

  at day 0

Secondary Outcomes (1)

• Compare the MASCC score and the Anh & al score

  up to 1 week

Study Arms (1)

the predictive value of ProCalcitonin

OTHER

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

Diagnostic Test: Value of ProCalcitonin

Interventions

Value of ProCalcitonin DIAGNOSTIC_TEST

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.

the predictive value of ProCalcitonin

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Chemotherapy-Induced Febrile Neutropenia

Condition Hierarchy (Ancestors)

Febrile Neutropenia; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• jean-Pascal Machiels, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 9, 2017
• Study Start: October 4, 2017
• Primary Completion: December 25, 2022
• Study Completion: December 25, 2022
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

BE (1)