Efficacy of LiveSpo Navax in Supportive Treatment of Pneumonia in Children With RSV and Bacterial Co-infections

NAActive, not recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

July 5, 2023

Primary Completion Date

July 27, 2024

Study Completion Date

March 31, 2025

Conditions
Acute Respiratory Tract InfectionsPneumoniaRespiratory Syncytial Virus (RSV)
Interventions
DRUG

0.9% NaCl physiological saline

Nasal-spraying 0.9% NaCl physiological saline is prepared by extracting 5 mL from 0.9% NaCl intravenous infusion 500 mL PP bottle (B.Braun, Germany, product declaration No. VD-32732-19), and then pouring it into the same opaque plastic spraying 10 mL-bottle that is used for LiveSpo Navax.

COMBINATION_PRODUCT

LiveSpo Navax

In Vietnam, LiveSpo Navax is manufactured as a Class-A medical device product (Product declaration No.210001337/PCBA-HN) under manufacturing standards approved by Hanoi Health Department, Ministry of Health, Vietnam (Certificate No YT117-19) and ISO 13485:2016.

Trial Locations (1)

10000

The Center for Pulmonology and Respiratory Care, Vietnam National Children's Hospital, Hà Nội

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Anabio R&D

INDUSTRY

lead

National Children's Hospital, Vietnam

OTHER

NCT05929599 - Efficacy of LiveSpo Navax in Supportive Treatment of Pneumonia in Children With RSV and Bacterial Co-infections | Biotech Hunter | Biotech Hunter