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IRCT20140818018842N37 IRCT 2023-12-14 Research Institute for Oncology, Hematology and Cell Therapy Comparison of high dose versus low dose of fluconazole for primary prevention of candida infections in patients with hematological malignancies, A single blind prospective randomized clinical trial Comparison of high dose versus low dose of fluconazole for primary prevention of candida infections in patients with hematological malignancies, A single blind prospective randomized clinical trial 2023-12-16 anticipated 120 Complete https://irct.ir/trial/69491 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Health service research, Other design features: This study will be conducted as a prospective, single-blind clinical trial on patients with hematological malignancies and hospitalized in the hematology departments of Shariati Hospital affiliated to Tehran University of Medical Sciences, Randomization description: In this study,In order to reduce bias, randomization is done by online randomization method by a statistician. the randomization process was conducted using the Clinical Trial Randomization Tool provided by the National Cancer Institute (NCI) https://ctrandomization.cancer.gov/ to assign 120 participants to two groups: Group A and Group B. This randomization procedure was performed in a double-blind manner, ensuring that both investigators and participants remained unaware of the group assignments, and the randomization process was blinded. Then, in order to reduce to zero the possibility of interfering in the selection of the intervention group by the researcher, 120 envelopes (containing number 1 to 120 and intervention group A or B) were prepared at the time of the start of the study based on the order of entry of the eligible participants into the study, randomly from one of the envelopes was sent to The order will be opened and the placement of the patient in the intervention group will be determined, Blinding description: Patients will be placed in one of two study groups and will be blinded to which study group they will be placed in. The drug is delivered to the patient by the researcher. And the nurses will be blind to which study group they are included in. 2-3 Occurrence of candidal infections (candidal colonization, superficial fungal infection, systemic fungal infection) in hematological malignancies,. Intervention 1: Intervention Group A: Patients receiving a low dose of oral fluconazole 150 mg once a day. Intervention 2: Intervention group B: Patients receiving a high dose of oral fluconazole 400 mg once a day. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public roghayeh savary kouehkonan
Kargar-e-shomali Ave, Shariati Hospital
tehran Iran (Islamic Republic of) 1411713131 +98 21 8490 2635 rsavary72@gmail.com Tehran University of Medical Sciences scientific Bita Shahrami
Kargar Shomali Ave, Shariati Hospital, Tehran, 14117-13135 I.R.Iran
Tehran Iran (Islamic Republic of) 1411713131 +98 21 8490 2635 bita.shahrami@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age above 18 years All patients with hematological malignancies can receive a prophylactic regimen against Candida, including: Patients with acute leukemia undergoing primary induction or salvage chemotherapy with the possibility of developing Mucositis Patients with acute leukemia or Myelodysplastic syndromes (MDS) who are expected to experience severe and fatal neutropenia (ANC<500 for more than 7 days) following chemotherapy Having the informed consent of the patient to participate in the study 18 years no limit Both Patients with history of idiosyncratic hypersensitivity reaction to azoles Patients with disturbed liver tests with transaminases more than 10 times the normal limit Life expectancy less than 3 weeks History of treatment with systemic antifungal drugs in the last two weeks Patients who have been diagnosed with a fungal infection and are suffering from a fungal infection Pregnancy Patients with increased QTc interval or Torsades de pointes Patients receiving drugs with major clinical interaction (category X) with fluconazole Having a history of invasive fungal infection requiring systemic treatment in the last 6 months Failure to receive fluconazole for more than 3 days during the study Patients with renal failure as CrCl ≤50 mL/min breastfeeding Treatment - Drugs Treatment - Drugs Intervention Group A: Patients receiving a low dose of oral fluconazole 150 mg once a day. Intervention group B: Patients receiving a high dose of oral fluconazole 400 mg once a day. The number of days receiving medicine for prophylaxis - the number of days the patient has been infected on preventive treatment. Timepoint: daily monitoring. Method of measurement: Questionnaire (checking the number of days). The type of organism isolated from the culture (fungus). Timepoint: It varies according to the patient's condition. Method of measurement: 72 hours after an unexplained fever in a patient, despite the start of antibiotic therapy, a sample is sent for culture from blood, urine, and tissues suspected of fungal infection, and if the microorganism grows, the strain is isolated and identified. The number of days that the patient has complications after taking the drug. Timepoint: daily monitoring. Method of measurement: Questionnaire (checking the number of days the patient has complications with the drug). The type of complications with drug. Timepoint: daily monitoring. Method of measurement: Questionnaire (checking the type of complication caused by the drug). The outcome of infection: death or patient recovery. Timepoint: daily monitoring. Method of measurement: Questionnaire (daily examination of the patient's clinical and laboratory conditions and the survival report of the patient on the days they receive the drug). Research Institute for Oncology, Hematology and Cell Therapy Approved 2022-07-17 The Institute of Pharmaceutical Sciences -Tehran University of Medical Sciences Poursina St., Tehran University of Medical Sciences, Faculty Pharmacy, Institute of Pharmaceutical Sciences (TIPS) tehran Tehran Iran (Islamic Republic of)