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IRCT20120415009475N8 IRCT 2020-08-04 Shahid Beheshti University of Medical Sciences Ceftazidime and Ciprofloxacin in the prevention of infection in children under transplantation Comparison of Ceftazidime and Ciprofloxacin as antimicrobial prophylaxis in pediatric undergoing Hematopoietic stem cell transplant patients 2020-08-22 anticipated 80 Complete https://irct.ir/trial/48648 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The randomization has been performed using the permuted block randomization table. The block randomization method is designed to randomize subjects into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time. In our study, subjects will be randomized in 4 patient blocks. Randomization was centralized and computerized with a concealed randomization sequence carried out at https://www.sealedenvelope.com/, Blinding description: The drug and placebo will be in coded same packages; a designated person will provide the codes from permuted block randomization via phone. The same person will group the data at the end of the trial, and the expert will perform statistical analysis and after results, the pocket that is with the placebo provider would be opened, and the data will be decrypted. The data regarding harm and benefits of treatment will be provided to the patient and caregiver. 3 Neutropenic fever in pediatric Hematopoietic stem cell transplantation. Intervention 1: Intervention group: Ciprofloxacin ten milligrams three times a day as an injectable drug. Intervention 2: Intervention group: receive ceftazidime fifty milligrams three times a day as an injectable drug. Yes - There is a plan to make this available What will be shared: The main outcome will be available. When: Six months after publishing data. To whom: The data will be available per request for people working in academic institutions. Conditions: the data will available for use in systematic review and meta-analysis. Where to obtain: the data will be available by contacting email; mirrahimi@sbmu.ac.ir. How to obtain: The request with the systematic review protocol will be reviewed and answered in two weeks. Comments:
public Dr. Bahador Mirrahimi
Mofid children's Hospital, Miradmad Junction, Shariaty Ave.
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7020 mirrahimi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dr. Bahador Mirrahimi
Mofid children's Hospital, Miradmad Junction, Shariaty Ave.
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7020 mirrahimi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) pediatric patients undergo stem cell transplantation 1 month 18 years Both Penicillin allergy Quinolone allergy Congenital Arrhythmia T86.0 Complications of bone marrow transplant Prevention Prevention Intervention group: Ciprofloxacin ten milligrams three times a day as an injectable drug Intervention group: receive ceftazidime fifty milligrams three times a day as an injectable drug Days without neutopenic fever from start of transplantation. Timepoint: Days. Method of measurement: Temperature measurement and White blood cell count. Hospital stay. Timepoint: Days. Method of measurement: Counting. White blood cell recovery time. Timepoint: Days. Method of measurement: The days until patient having two consecutive White blood cell counts above 1000 cells in milli Litre. Shahid Beheshti University of Medical Sciences Approved 2020-03-02 Institutional Ethics committee for Pharmacy, Nursing and Midwifery schools 2nd floor, School of Nursing and Midwifery, Valiasr Ave and Niayesh Highway junction Tehran Tehran Iran (Islamic Republic of)