Comparison of The Efficacy of Levofloxacin and Ciprofloxacin in Prevention of Bacterial Infection in Allogeneic Hematopoietic Stem Cell Transplant Recipients
Comparison of The Efficacy of Levofloxacin and Ciprofloxacin in Prevention of Bacterial Infection in Allogeneic Hematopoietic Stem Cell Transplant Recipients
Design
Two arm parallel group randomized trial with non blinded outcome assessment
Settings and conduct
in this randomized controlled trial, patients who admitted to bone marrow transplant ward from Taleqani hospital affiliated to Shahid Beheshti University of Medical Sciences who are candidate to receive allogenic hematopoetic stem cell transplant will enrolled. patients will be randomized in two groups of thirty (one group will receive Ciprofloxacin and another receive Levofloxacin). in each group patients will receive their antibiotic till engraftment or fever detection .
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Candidate for Allogeneic Stem Cell Transplantation;
age over 18
Non-iclusion criteria:
Chronic Kidney Disease;
Age over 65;
pregnancy;
Unwillingness to participate in the study;
Fever before engraftment ;
Fever before 21 days after transplantation;
Patients death
Intervention groups
Intervention group 1: Patients receiving Levofloxacin
Intervention group 2: Patients receiving Ciprofloxcacin
Main outcome variables
Confirmed infection
Fever detection;
Engraftment time;
Time of fever detection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100127003210N17
Registration date:2019-08-23, 1398/06/01
Registration timing:registered_while_recruiting
Last update:2019-08-23, 1398/06/01
Update count:0
Registration date
2019-08-23, 1398/06/01
Registrant information
Name
Maria Tavakoli Ardakani
Name of organization / entity
Faculty of pharmacy, Shaid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
mariatavakoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of The Efficacy of Levofloxacin and Ciprofloxacin in Prevention of Bacterial Infection in Allogeneic Hematopoietic Stem Cell Transplant Recipients
Public title
Levofloxacin in Hematopoetic stem cell transplant
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for Allogeneic Stem Cell Transplantation
Age over 18
Exclusion criteria:
Chronic renal failure
Age over 65
Pregnancy
Unwillingness to participate in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation sequence will computer generate and consist of series of group
number (either 1 = A or 2 = B) for each consecutive patient. Block randomization method will use
and each block will be consist of 10 patients. Each block includes 5 patients who will receive
Vitamin E and 5 patients from control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
6153- 14155
Approval date
2019-01-28, 1397/11/08
Ethics committee reference number
IR.SBMU.Pharmacy.REC.1397.217
Health conditions studied
1
Description of health condition studied
antibiotic prophylaxis in hematopoetic stem cell transplantation
ICD-10 code
T86.0
ICD-10 code description
Complications of bone marrow transplant
Primary outcomes
1
Description
fever detection
Timepoint
every 6 hours till engraftment
Method of measurement
Via mercury thermometer
2
Description
Infection
Timepoint
Daily till engraftment happen
Method of measurement
1. Clinical sign and symptoms. 2.Laboratory data
Secondary outcomes
1
Description
Duration of neutropenic status
Timepoint
Daily
Method of measurement
Blood Neutrophile count
2
Description
Hospital length of stay
Timepoint
Daily
Method of measurement
recording number of hospitalized days
3
Description
Need for other antibiotic consuption
Timepoint
Daily
Method of measurement
Patient's medication list
4
Description
Engraftment time
Timepoint
Daily
Method of measurement
Blood cells count
Intervention groups
1
Description
Intervention group: receiving Levofloxacin by dose of 500 mg per day in form of one tablet which is taken orally or intravenously if the patient is unable to take orally from day 1 post transplantation for 21 days or detecting fever or engraftment.
Category
Treatment - Drugs
2
Description
Intervention group: receiving Ciprofloxacin by dose of 500 mg every 12 hours in form of one tablet which is taken orally or intravenously if the patient is unable to take orally from day 1 post transplantation for 21 days or detecting fever or engraftment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani hospital
Full name of responsible person
Maria Tavakoli-Ardakani
Street address
Taleghani Educational Hospital, Tabnak St. Velenjak Region, Chamran High Way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
mariatavakoli@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Nima Naderi
Street address
Faculty of Pharmacy-Niyayesh intersection-Valiasr St
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
Mariatavakoli@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Omid Moradi
Position
Clinical Pharmacy Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
O_moradi@outlook.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Maria Tavakoli-Ardakani
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
mariatavakoli@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maria Tavakoli Ardakani
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Vali-e-asr Ave., Niayesh junction
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8887 3704
Fax
+98 21 8887 3704
Email
mariatavakoli@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Primary outcome data after making unrecognizable will be released
When the data will become available and for how long
6 months after publishing the results primary outcome data will be released
To whom data/document is available
Researchers after allowance of corresponding author could have the permission to have the
data
Under which criteria data/document could be used
Performing any analysis will be allowed only with the permission of corresponding author
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document
After requesting to reach data, corresponding author will check the allowance, then the
researcher will be informed about it