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IRCT20230701058628N1 IRCT 2023-07-18 Mazandaran University of Medical Sciences Investigating phage therapy in the prevention of ventilator-induced bacterial pneumonia in patients admitted to the pediatric intensive care unit 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 2021-06-24 anticipated 30 Complete https://irct.ir/trial/71030 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Ventilator-associated Bacterial Pneumonia. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Contact Dr.Mohammad Reza Navaeifar. Email: dr.navaifar@gmail.com When: Informations will send within few days after the email. To whom: People working in academic institutions Conditions: Contact Dr.Mohammad Reza Navaeifar. Email: dr.navaifar@gmail.com Where to obtain: Email How to obtain: Informations will send within few days after the email. Comments:
public Dr. Mohammad Reza Navaeifar
Pediatric Infectious Diseases |Research Center, Bouali Hospital, Pasdaran Boulevard, Sari
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 m.navaeifar@mazums.ac.ir Mazandaran University of Medical Sciences scientific Dr. Mohammadsadegh Rezai
Pediatric Infectious Diseases Research Center, Bouali Hospital, Pasdaran Boulevard, Sari, Iran
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 drmsrezaii@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age <18 years The reason for the need for mechanical ventilation is not bacterial pneumonia need for mechanical ventilation for more than 2 days 29 days 18 years Both Need ventilator <48 hours Neonates < 28 days J15 Bacterial pneumonia, not elsewhere classified Treatment - Drugs Placebo 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. 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. 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. 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). Death. Timepoint: Which day of hospitalization. Method of measurement: The time of death of the patient based on medical record. Discharge from PICU or hospital. Timepoint: One week after extubation. Method of measurement: Discharge from PICU or hospital based on medical record. Mazandaran University of Medical Sciences Approved 2021-06-23 Ethics committee of Mazandaran University of Medical Sciences Pediatric Infectious Diseases Research Center, Buali Hospital, Pasdaran Boulevard, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)