Mucormycosis. Rhinocerebral mucormycosis
Conditions
Interventions
Intervention 1: Intervention group: In this group, patients will receive Amphotericin vial ,manufactured by BDR Pharmaceuticals in India, at a dose of 5 milligram per kilogram in a single dose daily i
Sponsors
Ahvaz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age greater than 18 years. Proven or probable invasive mucormycosis, as defined by modification of consensus European Organization for Research and Treatment of Cancer (EORTC)/Mycosis Study Group (MSG) criteria. In brief, proven mucormycosis is defined as: 1) histopathologic or cytopathologic examination showing broad-based, aseptate, ribbon-like hyphae consistent with Mucorales from needle aspiration or biopsy specimen, with evidence of associated tissue damage (either microscopically or unequivocally by imaging); OR 2) a positive culture result for a sample obtained by sterile procedure from normally sterile and clinically or radiologically abnormal site consistent with infection, excluding urine and mucous membranes. Probable mucormycosis is defined as: 1) an at-risk host; AND 2) positive culture, cytology, or polymerase chain reaction (PCR) test (run at a CLIA-certified clinical microbiology laboratory) from sputum, bronchoalveolar lavage (BAL), endoscopy/colonoscopy, or sinus aspirate/biopsy; AND 3) 1 major or 2 minor clinical criteria.
Exclusion criteria
Exclusion criteria: High likelihood of death within the 48 h after enrollment (investigator's discretion). High likelihood of death due to factors unrelated to mucormycosis (e.g. due to uncontrolled and/or relapsed malignancy, severe graft versus host disease, other underlying diseases, etc.) within 30 days following enrollment (investigator's discretion). Patient unable to receive enteral medication (oral or via feeding tube). Patient is already taking deferasirox therapy for any reason at the time of screening. Patient is allergic to or intolerant of deferasirox or Amphotricin. Patient has significant renal dysfunction at the time of screening, defined as serum creatinine of > 3 mg/dL or a calculated creatinine clearance of 10 times the upper limit of normal, AND a direct (not total) bilirubin > 5 times the upper limit of normal. Women of child-bearing potential (those with menses within the last year) with a positive serum pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality. Timepoint: At the end of study. Method of measurement: Mortality rate.;Adverse Events. Timepoint: At all stages of treatment and hospitalization and at the end of the study. Method of measurement: National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.;Drug tolerance. Timepoint: Daily. Method of measurement: History. | — |
Secondary
| Measure | Time frame |
|---|---|
| Admission period. Timepoint: At the end of the study. Method of measurement: Calculation of the number of days of hospitalization. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSoheila Nikakhlagh
Ahvaz University of Medical Sciences
Outcome results
None listed