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IRCT20210429051130N2 IRCT 2021-11-19 Ahvaz University of Medical Sciences Evaluation of the efficacy and safety of Defrasirox as adjunctive therapy for Mucormycosis Evaluation of the efficacy and safety of Defrasirox as adjunctive therapy for Mucormycosis: a double-blind randomized controlled clinical trial 2021-11-22 anticipated 40 Complete https://irct.ir/trial/59815 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of patients to treatment groups is done by randomized block method using 4 blocks, which are selected from patients diagnosed with Mucormycosis after reviewing the inclusion and exclusion criteria. Unit of randomization is individual. Randomization is done using a table of random numbers and to generate random sequences a computer will be used. For concealing treatment allocation, the list of treatments are placed in the enclosed and numbered (to maintain order of sequences) envelopes. Randomization or random assignment of patients to each treatment group will be done by randomized block method using 4 blocks by winpepi 11.4 software. Subjects were randomly divided into two groups based on the method of quadruple random blocks, Blinding description: Participants (patients) and the treatment team and the analyzer are blind during the study. At the patient level, blindness will be performed using a placebo so that one group will be given Deferasirox and the other group will be given a placebo. , and they will not know which one they are given. . The researcher is only on the basis of label A or B , without knowing the nature of A, B and according to the randomization list, they give patients drugs or placebo. 2-3 Mucormycosis. 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 intravenous plus Deferasirox tablet ,manufactured by Nano Hayat Darou in Iran, at a dose of 10 milligram per kilogram in a single dose daily and orally for 28 days. Intervention 2: Control 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 intravenous plus placebo tablet at a dose of 10 milligram per kilogram in a single dose daily and orally for 28 days. Yes - There is a plan to make this available What will be shared: Information about the primary and secondary outcome after unidentified individuals will be shared. When: The access period will start 6 months after the results are published. To whom: The data will be available to researchers working in academic and scientific institutions. Conditions: For research and treatment purposes Where to obtain: Ahvaz Jundishapur University of Medical Sciences How to obtain: Send your request to Ahvaz Jundishapur University of Medical Sciences. Comments:
public Soheila Nikakhlagh
24 Metri Ave, Imam Khomeini hospital, Ahwaz city
Ahvaz Iran (Islamic Republic of) 6193665115 +98 61 3292 1838 nikakhlagh-s@ajums.ac.ir Ahvaz University of Medical Sciences scientific Soheila Nikakhlagh
24 Metri Ave, Imam Khomeini hospital, Ahwaz city
Ahvaz Iran (Islamic Republic of) 6193665115 +98 61 3229 1838 nikakhlagh-s@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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. 18 years no limit Both 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 < 30 ml/min (by the Cockroft-Gault formula: (140 - age (yrs) * wt (kg)) * 0.85 (for females) / (72 * serum creatinine (mg/dL)). Patient has significant hepatic dysfunction at the time of screening, defined as BOTH an AST or ALT > 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. B46.1 Rhinocerebral mucormycosis Treatment - Drugs Placebo 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 intravenous plus Deferasirox tablet ,manufactured by Nano Hayat Darou in Iran, at a dose of 10 milligram per kilogram in a single dose daily and orally for 28 days. Control 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 intravenous plus placebo tablet at a dose of 10 milligram per kilogram in a single dose daily and orally for 28 days. 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. Admission period. Timepoint: At the end of the study. Method of measurement: Calculation of the number of days of hospitalization. Ahvaz University of Medical Sciences Approved 2021-11-02 Ethics committee of Ahvaz Jondishapur University of Medical Sciences Iran- Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)