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OpenTrials
Completed

NCT Number: NCT02823132

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

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.

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Key information

Conditions

Acute Leukemia Bacterial Infections and Mycoses Infections Invasive Fungal Infection Invasive Fungal Infections Mycoses

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sample

Biological

Primary outcomes

  1. serum level of Mannose Binding Lectin (MBL) in patients with acute leukemia

    Time frame: 1st day of the period of aplasia

Secondary outcomes

  1. Serum levels of MBL during an episode of aplasia for both groups of patients studied

    Time frame: Every day except Saturday and Sunday for roughly 3 weeks

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study 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)

Acronym: MBL INFFONG

Important dates

Primary completion
2015
First posted
Jul 6, 2016
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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