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

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)

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03182465

Acronym

CALIF

Enrollment

Registered

2017-06-09

Start date

2017-10-04

Completion date

2022-12-25

Last updated

2023-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Neutropenia, Drug-Induced

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.

Interventions

DIAGNOSTIC_TESTValue 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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, .... )

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026