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

Febrile Neutropenia, Drug-Induced Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03182465
• Other study ID #: 2017/24FEV/112
• Status: Terminated
• Phase: N/A
• Start date: October 4, 2017
• Est. completion date: December 25, 2022

Study information

• Verified date: December 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: December 25, 2022
• Est. primary completion date: December 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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, .... )

Related Conditions & MeSH terms

• Bacteremia
• Chemotherapy-Induced Febrile Neutropenia
• Emergencies
• Febrile Neutropenia
• Febrile Neutropenia, Drug-Induced
• Fever
• Hyperthermia
• Neutropenia

Intervention

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.

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare the MASCC score and the Anh & al score	Based on the chareteristics of the two scores	up to 1 week