Comparing efficacy and safety of Colistin Loading dose regimen versus Conventional regimen in improving clinical and microbiological response for the treatment of multidrug resistant gram-negative infections in pediatrics
This study was designed to prove the hypothesis that loading dose of colistin is more effective than the conventional dose in improvement of life threatening Infections in pediatrics.
Design
The study is a multi center, single blind, parallel, phase III, randomized clinical trial. The sample size is 48.
Randomization was done through permuted block randomization method.
Settings and conduct
The study is scheduled to be conducted in the children medical center and Mofid hospital in Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria: age from 1 month to 18 years old; suffering from bacteremia or Ventilator associated pneumonia; a Gram-negative culture only susceptible to Colistin; Normal renal function before Colistin initiation; Colistin administered for at least 4 days.
Non inclusion criteria: Parents Dissatisfaction;
Receiving Nebulized form of Colistin for VAP;
Receiving antibiotics effective on gram negative micro organisms other than Colistin and Meropenem.
Intervention groups
In the intervention group, first a loading dose of Colistin is given to the child and then the child go on on maintenance dose. After 72 hours of starting Colistin, patient will be evaluated for clinical and microbial responses and nephrotoxicity and neurotoxicity. In the control group, from the beginning the patient will receive maintenance dose and the rest will be like the intervention group.
Main outcome variables
Clinical response; Microbial clearance; Resistance to Colistin; Nephrotoxicity; Neurotoxicity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170614034532N2
Registration date:2018-06-11, 1397/03/21
Registration timing:prospective
Last update:2018-06-11, 1397/03/21
Update count:0
Registration date
2018-06-11, 1397/03/21
Registrant information
Name
shiva fatehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6690 1887
Email address
sh_fatehi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing efficacy and safety of Colistin Loading dose regimen versus Conventional regimen in improving clinical and microbiological response for the treatment of multidrug resistant gram-negative infections in pediatrics
Public title
Colistin loading dose in pediatrics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Colistin receiving for at least four days
Normal baseline renal status before administration of Colistin
Children from 1 month to 18 years
Children with a positive blood culture or VAP
Gram negative culture which is only susceptible to Colistin
Exclusion criteria:
Parents Dissatisfaction
Receiving Nebulized form of Colistin for VAP
Receiving antibiotics effective on gram negative micro organisms other than Colistin and Meropenem
Age
From 1 month old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The Method for randomization in this RCT is permuted block randomization.
The unit of randomization is persons.
The tool for randomization is random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study after Obtaining consent letter from the child's parents,the child will be randomly placed in one of the interventional or control group.Since the researcher and the physician and nurse that are responsible for the patients know that the child is receiving Colistin loading dose or not ,so the study is single blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Faculty of Pharmacy, Tehran University of Medical Sciences, Enghelab Ave, Tehran,
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2017-06-25, 1396/04/04
Ethics committee reference number
1396.2744
Health conditions studied
1
Description of health condition studied
bloodstream infections
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Ventilator Associated Pneumonia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Clinical response
Timepoint
at the beginning of the study (before starting the intervention) and 72 hours after the start of treatment
Method of measurement
Laboratory data
2
Description
Microbiological response
Timepoint
at the beginning of the study (before starting the intervention) and 72 hours after the start of treatment
Method of measurement
Microbial culture
Secondary outcomes
1
Description
The prevalence and severity of Nephrotoxicity
Timepoint
72hrs after starting Colistin
Method of measurement
Laboratory data; Measurement of Urine Volume
2
Description
The prevalence of Neurotoxicity
Timepoint
72hrs after starting Colistin
Method of measurement
Clinical outcomes
3
Description
The prevalence of Colistin resistance
Timepoint
72hrs after starting Colistin
Method of measurement
Microbial culture
Intervention groups
1
Description
Intervention group: Patients receive a loading dose of 150,000 IU/Kg.The loading dose is followed by 50,000 IU every 8 hours. Clinical, microbiological and laboratory findings are collected for each patient on 1th and 4th day after treatment.The Nephrotoxicity is assessed based on PRIFLE recommendation on day 4 after treatment.
Category
Treatment - Drugs
2
Description
Control group:Patients receive Colistin at the dose of 50,000 IU every 8 hours. Clinical, microbiological and laboratory findings are collected for each patient on 1th and 4th day after treatment.The Nephrotoxicity is assessed based on PRIFLE recommendation on day 4 after treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children medical center
Full name of responsible person
Shiva Fatehi
Street address
Dr.Qarib Street,Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1418844351
Phone
+98 21 6690 1887
Email
shiva.fatehi@yahoo.com
2
Recruitment center
Name of recruitment center
Mofid hospital
Full name of responsible person
Bahador Mirrahimi
Street address
Shariati Street
City
Tehran
Province
Tehran
Postal code
1418844351
Phone
+98 21 6690 1887
Email
shiva.fatehi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
6th floor,central university building,Quds Street,Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1418844351
Phone
+98 21 8163 3698
Email
shiva.fatehi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
دانشگاه علوم پزشکی تهران
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
Tehran University of Medical Sciences
Full name of responsible person
Shiva Fatehi
Position
Resident of Clinical pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Clinical pharmacist
Street address
No 39, Tabatabaei Ave, North Kargar street, Enghelab square
City
Tehran
Province
Tehran
Postal code
1418844351
Phone
+98 21 6690 1887
Email
shiva.fatehi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shiva Fatehi
Position
Resident of Clinical Pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 39, Tabatabaei Ave, North Kargar street, Enghelab Square
City
Tehran
Province
Tehran
Postal code
1418844351
Phone
+98 21669018878
Email
shiva.fatehi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shiva Fatehi
Position
Medical Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
North Kargar street
City
Tehran
Province
Tehran
Postal code
1418844351
Phone
+98 21 6690 1887
Email
shiva.fatehi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD