The aim of this study is to evaluate the effect of oral suspension azithromycin on chemotherapy induced mucositis.Inclusion criteria included patients undergoing bone marrow transplantation is satisfactory and exclusion criteria azithromycin drug allergy or lack of patient satisfaction.The study population of patients undergoing bone marrow transplantation Taleghani Hospital and the sample size of 60 is considered.Intervention effect of azithromycin drug prevention and treatment of mucositis patients in this study lists the Persian date Bahman 1394 to Persian date Bahman 1396.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201603093210N13
Registration date:2017-02-09, 1395/11/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-09, 1395/11/21
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
School of pharmacy, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-12-31, 1394/10/10
Expected recruitment end date
2017-12-31, 1396/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of azithromycin oral suspension on the prevention and treatment of mucositis in Hematopoietic Stem Cell Transplant recipients
Public title
Evaluation the effect of azithromycin oral suspension on the mucositis in patients undergoing Hematopoietic Stem Cell Transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients hospitalized in bone marrow transplantation and patients undergoing chemotherapy;Patients satisfaction to participate in the study
The exclusion criteria:
Unwillingness of patients to continue;Allergic reactions to medication or other subunits of mouthwash
Age
From 12 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 the Faculty of Pharmacy, University shahid Beheshti
Street address
niyayesh.vali-asr
City
tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.SBMU.PHNM.1394.307
Health conditions studied
1
Description of health condition studied
• C00-D49 Neoplasms
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
mucositis
Timepoint
first day of chemotherapy until engraftment day
Method of measurement
WHO scoring system
Secondary outcomes
1
Description
fever grade
Timepoint
From the first day of chemotherapy until engraftment time
Method of measurement
Submit a fever above 38.5 ° C for patients
2
Description
The need fortotal parenteral nutrition(TPN)
Timepoint
During the study period
Method of measurement
SignTthe daysof parenteral nutrition intake
Intervention groups
1
Description
Azithromycin oral suspension 300mg twice daily from first day of chemotherapy until engraftment day plus standard supportive care for mucositis in intervention group versus standard care of mucositis in control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
the bone marrow transplantasion departmant of taleghani hospital
Full name of responsible person
Street address
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Maria Tavakoli-Ardakani
Full name of responsible person
00989121863686
Street address
Vali-e Asr Ave, Niayesh Junction
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Maria Tavakoli-Ardakani
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Students Research committee, School of pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohadeseh Zeraatkar
Position
Pharm D student
Other areas of specialty/work
Street address
Vali-e Asr Ave., Niayesh junction
City
Tehran
Postal code
Phone
+98 912 687 5781
Fax
Email
m2zeraatkar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
clinical pharmacy department, scholl of pharmacy & pharmaceutical sciences research center, Shahid B
Full name of responsible person
Maria Tavakoli-Ardakani
Position
Associate professor
Other areas of specialty/work
Street address
Vali-e Asr Ave., Niayesh junction
City
Tehran
Postal code
Phone
+98 21 8887 3704
Fax
Email
mariatavakoli@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Mohadeseh Zeraatkar
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)