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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230701058628N1

Enrollment

Registered

2023-07-18

Start date

2021-06-24

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator-associated Bacterial Pneumonia. Bacterial pneumonia, not elsewhere classified

Interventions

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

Eligibility

Sex/Gender

All

Age

29 Days to 18 Years

Inclusion 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

Exclusion criteria: Need ventilator <48 hours Neonates < 28 days

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Secondary

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Reza Navaeifar

Mazandaran University of Medical Sciences

m.navaeifar@mazums.ac.ir+98 11 3334 2334

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026