Evaluation of phage therapy in prevention of bacterial pneumonia caused by ventilator in patients admitted to Pediatric Intensive Care Unit of Buali Hospital of Sari
Determining the effect of phage therapy in preventing ventilator-induced bacterial pneumonia in patients hospitalized in Pediatric Intensive Care Unit
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 0 on 60 patients.
Settings and conduct
This double-blind randomized clinical trial is conducted to prevent ventilator-induced bacterial pneumonia in patients admitted to the Pediatric Intensive Care Unit (PICU) of BuAli Hospital in Sari. Patients are randomly selected by age block and divided into two intervention and control groups in parallel. The patient and the researchers do not know the contents of the vials. Phage and placebo cocktails are prepared with the same shape and color in the laboratory of the research center by the relevant expert.
Participants/Inclusion and exclusion criteria
People under 18 years of age, whose reason for needing mechanical ventilation is not bacterial pneumonia and need ventilator for more than 2 days are included in the study, and people who use a ventilator for less than 48 hours and babies under 28 days old are excluded from the study.
Intervention groups
The intervention group receive phage cocktail with a titer of 10*12 PFU/mL every 24 hours for 20 minutes with a mesh nebulizer.
The placebo group receive 10 cc of phage-free phage-based suspension every 24 hours for 20 minutes with a mesh nebulizer.
Phage and placebo cocktail suspension is prepared in 10 cc vials and delivered to the nurse for use.
Main outcome variables
Primary outcome: positive tracheal culture or occurrence of Ventilator-induced pneumonia
Secondary outcome: death or discharge from PICU or discharge or one week after extubation
Changes in the course of the patient during the hospitalization days from the start of the intervention until the end of the study will be recorded daily.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230701058628N1
Registration date:2023-07-18, 1402/04/27
Registration timing:retrospective
Last update:2023-07-18, 1402/04/27
Update count:0
Registration date
2023-07-18, 1402/04/27
Registrant information
Name
Mohammad Reza Navaeifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 2334
Email address
m.navaeifar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-24, 1400/04/03
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
2021-06-26, 1400/04/05
Actual recruitment end date
2023-03-20, 1401/12/29
Trial completion date
empty
Scientific title
Evaluation of phage therapy in prevention of bacterial pneumonia caused by ventilator in patients admitted to Pediatric Intensive Care Unit of Buali Hospital of Sari
Public title
Investigating phage therapy in the prevention of ventilator-induced bacterial pneumonia in patients admitted to the pediatric intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age <18 years
The reason for the need for mechanical ventilation is not bacterial pneumonia
need for mechanical ventilation for more than 2 days
Exclusion criteria:
Need ventilator <48 hours
Neonates < 28 days
Age
From 29 days old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by simple randomization method with age block. Nebulizer solutions are prepared and coded in the laboratory by the relevant expert, and the treatment team will not know the suspension content, and only based on the initial determined group, the desired solution will be delivered to the treatment team daily. The laboratory personnel will not be informed about the patient and the treatment process.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted in a double-blind manner, and the patient and researchers (nurses, doctors) are considered blind. Phage cocktail and placebo are prepared in exactly the same packages for nebulization, and group A and B labels are marked on the products by the co-producer of the cocktail and placebo. The laboratory colleague is not involved in the statistical analysis and checking the results.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Pediatric Infectious Diseases Research Center, Buali Hospital, Pasdaran Boulevard, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Approval date
2021-06-23, 1400/04/02
Ethics committee reference number
IR.MAZUMS.REC.1400.305
Health conditions studied
1
Description of health condition studied
Ventilator-associated Bacterial Pneumonia
ICD-10 code
J15
ICD-10 code description
Bacterial pneumonia, not elsewhere classified
Primary outcomes
1
Description
Positive endotracheal culture
Timepoint
Once every three days from the time of drug nebulization
Method of measurement
Culture by mini-BAL (Mini bronchoalveolar lavage) method
2
Description
Occurance of Ventilator-associated pneumonia
Timepoint
Daily
Method of measurement
Fever above 38°C without any other cause or white blood cell below 4000 or leukocytosis ≥ 12000 white cells per cubic millimeter and at least two cases of new purulent sputum onset, change in sputum characteristics, increased respiratory secretions or increased need for suction, onset or worsening of cough, shortness of breath or tachypnea; rales or bronchial lung sounds; Worsening of blood gases (for example, increased need for oxygen or increased ventilator settings)
Secondary outcomes
1
Description
Death
Timepoint
Which day of hospitalization
Method of measurement
The time of death of the patient based on medical record
2
Description
Discharge from PICU or hospital
Timepoint
One week after extubation
Method of measurement
Discharge from PICU or hospital based on medical record
Intervention groups
1
Description
Intervention group: The intervention group receives the phage cocktail made by the laboratory of the Pediatric Infectious Diseases Research Center with a titer of 10x12 PFU/mL every 24 hours for 20 minutes with a mesh nebulizer. Phage cocktail suspension is prepared in 10 cc vials and delivered to the nurse for use. The doctor and the person collecting the information do not know about placebo and phage cocktail suspension.
Category
Treatment - Drugs
2
Description
Control group: The control group receives 10 cc suspension with phage composition base without phage every 24 hours for 20 minutes with mesh nebulizer device. Placebo suspension is prepared in 10 cc vials and delivered to the nurse for use. The doctor and the person collecting the information do not know about placebo and phage cocktail suspension.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Buali Hospital
Full name of responsible person
Dr. Mohammad Reza Navaeifar
Street address
Pediatric Infectious Diseases Research Center, Buali Hospital, Pasdaran Boulevard, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 911 325 2944
Email
m.navaeifar@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnejad
Street address
Vice chancellor for Research, Moallem square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4712855689
Phone
+98 11 3448 4800
Email
pebrahimnejad@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Navaeifar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric intensive care unit fellow
Street address
Pediatric Infectious Diseases |Research Center, Bouali Hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
m.navaeifar@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammadsadegh Rezai
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric Infectious Diseases Research Center, Bouali Hospital, Pasdaran Boulevard, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
drmsrezaii@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Navaeifar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric Infectious Diseases |Research Center, Bouali Hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
m.navaeifar@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)