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

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ClinicalTrials.gov Identifier: NCT03182465
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Febrile Neutropenia, Drug-Induced Diagnostic Test: Value of ProCalcitonin Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
Actual Study Start Date : October 4, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Compare the MASCC score and the Anh & al score [ Time Frame: up to 1 week ]
    Based on the chareteristics of the two scores



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, .... )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182465


Contacts
Contact: Jean-Pascal Machiels, MD, PhD 00322764 ext 5457 jean-pascal.machiels@uclouvain.be
Contact: Gaetan Catala, MD 00322764 ext 4231 gaetan.catala@uclouvain.be

Locations
Belgium
Cliniques universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Jean-Pascal Machiels, MD, PhD    00322764 ext 5457    jean-pascal.machiels@uclouvain.be   
Contact: Gaetan Catala, MD    00322764 ext 4231    gaetan.catala@uclouvain.be   
Sub-Investigator: Andrea Penazola, MD, PhD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: jean-Pascal Machiels, MD, PhD Cliniques universitaires Saint-Luc

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03182465     History of Changes
Other Study ID Numbers: 2017/24FEV/112
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: There is no plan to share IPD at this moment

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fever
Febrile Neutropenia
Chemotherapy-Induced Febrile Neutropenia
Emergencies
Neutropenia
Bacteremia
Disease Attributes
Pathologic Processes
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Body Temperature Changes
Signs and Symptoms
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs