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 the effectiveness of high and low dose fluconazole in the primary prevention of candidal infections in patients with hematological malignancies
Design
This study will be conducted as a single-blind prospective clinical trial on 120 patients with hematologic malignancies. Half of the patients will receive a low-dose of oral fluconazole and the remaining half will receive a high-dose of oral fluconazole. daily monitoring routine will be carried out .
Settings and conduct
The study will be carried out on 120 patients with hematologic malignancies and hospitalized in the hematology departments of Shariati Hospital The medicine prescription will be started along with the first course of chemotherapy and the duration of receiving treatment will be continued until the amount of the ANC is less than 10 109 per liter.
Data will be collected based on pre-designed questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria, patients over 18 years old , Patients with acute hematological malignancies are candidates for anti,Candida prophylactic regime , patient consent .
Exclusion criteria idiosyncratic allergic reaction to azoles , transaminases 10 times more than the normal limit , CrCl less than equal to 50 ml/min , treatment history with systemic anti fungal drugs in the last two weeks ,Pregnancy or breastfeeding - Increased QTc interval , Major clinical interaction (category X)
Intervention groups
A: Patients receive 150 mg of fluconazole once a day (oral tablet).
B: patients receive 400 mg of oral fluconazole once a day
Main outcome variables
The number of days of receiving the drug for prophylaxis, - The number of days after which the patient on preventive treatment suffered from a fungal infection, the type of microorganism isolated from the the cultivation environment, The outcome of infection in each group : Death or patient Recovery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140818018842N37
Registration date:2023-12-14, 1402/09/23
Registration timing:prospective
Last update:2023-12-14, 1402/09/23
Update count:0
Registration date
2023-12-14, 1402/09/23
Registrant information
Name
Leyla Sharifi Aliabadi
Name of organization / entity
Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 3691
Email address
ctu@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-16, 1402/09/25
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Other
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Institute of Pharmaceutical Sciences -Tehran University of Medical Sciences
Street address
Poursina St., Tehran University of Medical Sciences, Faculty Pharmacy, Institute of Pharmaceutical Sciences (TIPS)
City
tehran
Province
Tehran
Postal code
14176-13151
Approval date
2022-07-17, 1401/04/26
Ethics committee reference number
IR.TUMS.TIPS.REC.1401.040
Health conditions studied
1
Description of health condition studied
Occurrence of candidal infections (candidal colonization, superficial fungal infection, systemic fungal infection) in hematological malignancies,
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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)
Secondary outcomes
1
Description
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.
2
Description
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)
3
Description
the type of complications with drug
Timepoint
daily monitoring
Method of measurement
Questionnaire (checking the type of complication caused by the drug)
4
Description
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)
Intervention groups
1
Description
Intervention Group A: Patients receiving a low dose of oral fluconazole 150 mg once a day.
Category
Treatment - Drugs
2
Description
Intervention group B: Patients receiving a high dose of oral fluconazole 400 mg once a day.