Comparative clinical study of the effectiveness of TauroLock™ solution with piperacillin-tazobactam as secondary prophylaxis of Port-Catheter infection in children with cancer
Comparison the effectiveness of TauroLock™ solution with piperacillin-tazobactam as secondary prophylaxis of Port-a-Cath infection in children with cancer.
Design
This is a double-blind, randomized, controlled clinical trial in which a random block method is used and two groups are in parallel.
Settings and conduct
Amir Oncology Hospital.
In this study, the participants and the evaluator (the microbiologist who records the final result of the growth medium) will be unaware of the intervention groups.
Participants/Inclusion and exclusion criteria
Patients between 0-19 years old who suffer from cancer and have the port in Amir Oncology Hospital
Exclusion criteria: critically ill patients, patients who have an active fungal infection and give antifungal treatments.
Intervention groups
Intervention group: 3-5 milliliters of piperacillin-tazobactam from 10 micromoles/ml will be injected into port when the port is not in use. This dose will be repeated every 14 days. Control group: 3-5 milliliters of TauroLock HEP 100 antiseptic solution will be injected into port when the port is not in use. This dose will be repeated every 14 days.
Main outcome variables
The incidence of bloodstream infection due to port infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180309039013N1
Registration date:2018-06-08, 1397/03/18
Registration timing:registered_while_recruiting
Last update:2018-06-08, 1397/03/18
Update count:0
Registration date
2018-06-08, 1397/03/18
Registrant information
Name
Nazafarin Hatami mazinani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 0861
Email address
stud0310548225@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative clinical study of the effectiveness of TauroLock™ solution with piperacillin-tazobactam as secondary prophylaxis of Port-Catheter infection in children with cancer
Public title
Evaluation of the effect of TauroLock™ and piperacillin-tazobactam in secondary prophylaxis of Port-Catheter infection.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having Port-Catheter
Age between 0-19
Having cancer
Exclusion criteria:
Critically ill patients
Patients with severe coagulation problems
No permission from child's parents
Age
From 1 day old to 19 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method was used which the patient was the randomization unit. For this purpose, computer software was used to define the blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants and the evaluator (the microbiologist who records the final result of the growth medium) will be unaware of the intervention groups. For blinding the statistical specialist, the encoding of the groups and participants will be done by a third person and the code definition will not be available to the statistician. additionally, due to the nature of the study, physician and the nurses will be aware of the control and intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences,setad Ave.,Zand Blvd.,Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2016-11-14, 1395/08/24
Ethics committee reference number
IR.SUMS.MED.REC.1395.45
Health conditions studied
1
Description of health condition studied
Infection due to port catheter
ICD-10 code
T85.7
ICD-10 code description
Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts
Primary outcomes
1
Description
The rate of infection of systemic bloodstream incidence due to port infection
Timepoint
Before the beginning of the intervention, once a day during the intervention, and at the end of the intervention
Method of measurement
Positive blood culture according to standard microbiological process
Secondary outcomes
1
Description
Port survival rate (No need to exit port or reload)
Timepoint
Once a day during the intervention, and at the end of the intervention
Method of measurement
I will record the change of port by observation.
Intervention groups
1
Description
Intervention group: Individuals in this group will be injected from the antibiotic solution of Piperacillin Tazobactam in proportion to the port volume, 3-5 cc.
Category
Prevention
2
Description
Control group: Individuals in this group will be injected from the TauroLock™ solution in proportion to the port volume, 3-5 cc.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir oncology hospital
Full name of responsible person
Nazafarin Hatami Mazinani
Street address
Amir Oncology Hospital, Station 11 of Farhangshahr, Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۸۷۹۱۵۹۹۸
Phone
+98 71 3632 3731
Email
amirhosp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seied Basir Hashemi
Street address
Shiraz University of Medical Sciences, Setad Ave., Zand Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
713457978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Ali Amanati
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Amir Oncology Hospital,Station 11of Farhangshahr, Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۹۳۶۳۶۵۶۸
Phone
+98 71 3632 3731
Email
Ali_amanati_1356@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Amanati
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Amir Oncology Hospital,Station 11 of Farhangshahr, Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۹۳۶۳۶۵۶۸
Phone
+98 71 3632 3731
Email
Ali_amanati_1356@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nazafarin Hatami mazinani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Amir oncology hospital, Station 11of Farhangshahr, Shiraz
City
Shiraz
Province
Fars
Postal code
7194733681
Phone
+98 71 3627 0861
Fax
Email
Stud0310548225@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available