Comparison of the effect of two doses of filgrastim (5 and 15 μg/kg) on absolute neutrophil counts in children with cancers
Design
clinical trial with two parallel, randomized and non-blind groups
Settings and conduct
Neutropenia patients admitted to Gorgan Taleghani Hospital oncology center who had inclusion/ exclusion criteria will assign to two groups by random allocation list. then by a checklist increasing rate of ANC, number of admission days, antibiotics & type of malignancy will be compared in two groups.
Administration of antibiotics will be according to protocol, First, ceftriaxone and amikacin will be prescribed, If no response to treatment is given after 48 hours, vancomycin will be prescribed, if it does not respond again ceftriaxone will be changed to ceftazidime. for checking fever T chart is provided, also for blood components every 48 hours patients CBC are taken, if ANC > 1500 medication will be stopped.
Participants/Inclusion and exclusion criteria
inclusion criteria:
patients with cancer associated with neutropenia; Parents informed consent; patients with absolute neutrophil count<1500 with one of the following items:
1.Neutropenia lasts for more than 7-10 days
2.Low blood pressure
3.Profound neutropenia
4.Sepsis
5.Pneumonia
6.fungal infections
exclusion criteria:
Patients with less than 1500 neutrophils while they have active leukemia or leukemia is not in the remission phase
Intervention groups
Group A will receive dose 5 and Group B 15 of the drug. Considering that the dose of 5 to 10 is used routinely in the therapeutic centers. Therefore, patients receiving the dose of 5 group A define as control group and patients receiving the dose of 15 group B as the intervention group
Main outcome variables
The absolute neutrophil count; number of hospitalization days; number of days that patient received antibiotics; time taken to stop the fever
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038196N8
Registration date:2019-07-13, 1398/04/22
Registration timing:retrospective
Last update:2019-07-13, 1398/04/22
Update count:0
Registration date
2019-07-13, 1398/04/22
Registrant information
Name
Amir Hossein Salimi Kordasiabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3425 6335
Email address
hosseininejad.s.mohsen@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of two doses of filgrastim (5 and 15 Microgram/ kg) on the absolute neutrophil count in children with cancer
Public title
Comparison of the effect of two doses of filgrastim in the treatment of neutropenia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients with cancer associated with neutropenia
Parents' informed consent for their child's participation in the study
patients with absolute neutrophil count<1500 with one of the following items:
Neutropenia lasts for more than 7-10 days
Low blood pressure
Profound neutropenia
Sepsis
pneumonia
fungal infections
Exclusion criteria:
Patients with less than 1500 neutrophils while they have active leukemia or their leukemia is not in the remission phase.
Age
To 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated to one of the two groups A (5 Dose) or B (15 Dose). In such a way that drugs with doses of 5 and 15 will be prepared in similar packages, then, according to the sample size in each group, Using the Excel software in a column, a list of letters A and B will be created and in the next column a list of random numbers will be generated. And then the column of letters will be arranged based on the column of random numbers. then a sequence of random letters of A and B will be obtained. Assign the next column to the numbering, The number recorded against the letters A and B will be recorded on a package of the corresponding dose drug. and the Packages are provided to the therapist. Eligible patients will receive a package medication based on their order of referral, The name of the patient and the number on medication package will be included in a list and will be made available to the project executives.
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 Gorgan university of medical sciences
Street address
Golestan Medical University,5th kiloometer Gorgan-Sari Road-at the beginning of the Shastkola street,Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2017-06-23, 1396/04/02
Ethics committee reference number
ir.goums.rec.1396.289
Health conditions studied
1
Description of health condition studied
Neutropenia
ICD-10 code
D70
ICD-10 code description
Neutropenia
Primary outcomes
1
Description
ANC increase rate
Timepoint
Each 48 hours will be done, and when the ANC is over 1500, the medication will be discontinued
Method of measurement
Study of CBC Elements
2
Description
number of hospitalization days
Timepoint
Hospitalize duration
Method of measurement
from patient documents
3
Description
number of days that patient received antibiotics
Timepoint
Hospitalize duration
Method of measurement
from patient documents
4
Description
time taken to stop the fever
Timepoint
Hospitalize duration
Method of measurement
from patient documents
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Patients will receive daily 5μg/kg of G-CSF (Filgrastim brand) in addition to the antibiotic received in accordance to the protocol.
Category
Treatment - Drugs
2
Description
Second intervention group: Patients will receive daily 15μg/kg of G-CSF (Filgrastim brand) in addition to the antibiotic received in accordance to the protocol.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital in Gorgan
Full name of responsible person
Dr Sepide Bagheri
Street address
Taleghani Hospital,janbazan Blv,gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 2166 0017
Fax
+98 17 3242 4377
Email
salimia92@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr Sepide Bagheri
Street address
Golestan Medical University,5th kiloometer Gorgan-Sari Road-at the beginning of the Shastkola street,Gorgan
City
Gorgan
Province
Golestan
Postal code
2546324313
Phone
+98 17 3243 0319
Fax
+98 17 3243 0310
Email
salimia92@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Dr Sepide Bagheri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Taleghani Hospital,janbazan Blv,gorgan
City
gorgan
Province
Golestan
Postal code
3465463214
Phone
+98 17 1442 1657
Fax
+98 17 3243 0319
Email
salimia92@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr Sepide Bagheri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Golestan Medical University,5th kiloometer Gorgan-Sari Road-at the beginning of the Shastkola street,Gorgan
City
gorgan
Province
Golestan
Postal code
3452475431
Phone
+98 17 1442 1657
Fax
+98 17 3243 0319
Email
salimia92@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Amir Hossein Salimi kordasiabi
Position
General medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Edalat 97 ,Minagol 2,Gorgan
City
gorgan
Province
Golestan
Postal code
3654236531
Phone
+98 17 3214 4009
Email
salimia92@gmail.com
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data can be shared after unidentifiable individuals
When the data will become available and for how long
6 months after completion of the study
To whom data/document is available
Professors and medical students
Under which criteria data/document could be used
It does not matter
From where data/document is obtainable
Send email to salimia92@gmail.com
What processes are involved for a request to access data/document