Study of the Level of a Protein Which Could Predict the Development of a Fungal Infection in Patients With Acute Leukemia

Acute Leukemia Clinical Trial

— MBL INFFONG  

Official title:

Study of the Level of Mannose Binding Lectin (MBL) as a Predictor of the Onset of a Invasive Fungal Infection (IFI) During Chemo-induced Aplasia in Patients With Acute Leukemia (AL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823132
• Other study ID #: Goyer APJ 2013
• Status: Completed
• Phase: N/A
• First received: June 29, 2016
• Last updated: July 5, 2016

Study information

• Verified date: June 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

The aim of this study is to investigate levels of a protein, mannose binding lectin, in patients with acute leukemia who develop or not an invasive fungal infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria :

• persons who have provided written consent

• Patients with national health insurance cover

• Patients with malignant hemopathy who have been treated with chemotherapy able to induce profound neutropenia (PN < 500 / mm3) lasting more than 10 days.

• Patients with malignant hemopathy who have received an autologous bone marrow graft

• Patients with severe idiopathic medullar aplasia (PN < 500 / mm3) who need to be hospitalized for at least 10 consecutive days (with or without treatment with immunosuppressants)

Exclusion Criteria:

• Patients who have received an bone marrow PSC allograft (as such patients have a risk of aspergillosis, which appears in most cases after medullar recovery; they will not be included in the study).

• Patients who have received an autologous PSC graf (as the duration of neutropenia is in most cases less than 10 days).

• Patients whose neutropenia, retrospectively assessed, lasted less than 10 days.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Communicable Diseases
• Infection
• Invasive Fungal Infection
• Leukemia
• Mycoses

Intervention

Biological:
• blood sample

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum level of Mannose Binding Lectin (MBL) in patients with acute leukemia		1st day of the period of aplasia	No
Secondary	Serum levels of MBL during an episode of aplasia for both groups of patients studied		Every day except Saturday and Sunday for roughly 3 weeks	No