Determination of efficacy and safety of ciprofloxacin in the prevention of neutropenic fever in children
Design
Randomized, parallel-group trial with blinded intervention and outcome assessment. Randomization was centralized and computerized with a concealed randomization sequence carried out at https://www.sealedenvelope.com/.
Settings and conduct
In this study, 80 children undergoing hematopoietic stem cell transplantation hospitalized in Mofid children hospital will enroll in the study after getting informed consent from parents. The patients will be divided into two groups, and a drug package with a unique code will be delivered to them. The patient, the caregiver, and the investigator will be blind to the package content.
Participants/Inclusion and exclusion criteria
Inclusion criteria: pediatric patients aged from one month to eighteen years undergoing hematopoietic stem cell transplantation.
Exclusion criteria: sensitivity to Ciprofloxacin or ceftazidime, Cardiac disease.
Intervention groups
In one group, patients receive Ciprofloxacin ten milligrams three times a day and in the other group receive Ceftazidime fifty milligrams three times a day as an injectable drug.
Main outcome variables
Days without neutropenic fever
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120415009475N8
Registration date:2020-08-04, 1399/05/14
Registration timing:prospective
Last update:2020-08-04, 1399/05/14
Update count:0
Registration date
2020-08-04, 1399/05/14
Registrant information
Name
Bahador Mirrahimi
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0118
Email address
mirrahimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Ceftazidime and Ciprofloxacin as antimicrobial prophylaxis in pediatric undergoing Hematopoietic stem cell transplant patients
Public title
Ceftazidime and Ciprofloxacin in the prevention of infection in children under transplantation
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 (investigator's opinion)
Triple blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Ethics committee for Pharmacy, Nursing and Midwifery schools
Street address
2nd floor, School of Nursing and Midwifery, Valiasr Ave and Niayesh Highway junction
City
Tehran
Province
Tehran
Postal code
1546815514
Approval date
2020-03-02, 1398/12/12
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.333.
Health conditions studied
1
Description of health condition studied
Neutropenic fever in pediatric Hematopoietic stem cell transplantation
ICD-10 code
T86.0
ICD-10 code description
Complications of bone marrow transplant
Primary outcomes
1
Description
Days without neutopenic fever from start of transplantation
Timepoint
Days
Method of measurement
Temperature measurement and White blood cell count
Secondary outcomes
1
Description
Hospital stay
Timepoint
Days
Method of measurement
Counting
2
Description
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.
Intervention groups
1
Description
Intervention group: Ciprofloxacin ten milligrams three times a day as an injectable drug
Category
Prevention
2
Description
Intervention group: receive ceftazidime fifty milligrams three times a day as an injectable drug