175
Participants
Start Date
October 28, 2021
Primary Completion Date
April 5, 2024
Study Completion Date
August 1, 2024
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.
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
Augmentin 500Mg Tablet
Augmentin (GlaxoSmithKline Pte, product declaration No. VN-20169-16) is an oral antibiotic available in the form of 625 mg tablets, which are prescribed as routine treatment for children and adults, respectively.
Acetylcysteine
Acetylcysteine 200 mg (STADA Vietnam, product declaration No. VD-22667-15) is an oral expectorant, which is prescribed as routine treatment for children and adults, respectively.
Xylometazoline Nasal
Otrivin (Xylometazoline 0.05%) (Novartis VietNam, product declaration No. VN-15558-12) is a nasal-spraying decongestant, which is prescribed as routine treatment for children and adults, respectively.
Cefotaxime
Imetoxim 1g (Cefotaxime 1g) (Imexpharm Pharmaceutical, product declaration No. VD-26846-17) is an injection or infusion-administrative antibiotic, which is prescribed as routine treatment for children.
Ciprofloxacin
Ciprofloxacin 0.3% (Vidipha Central Pharmaceutical, product declaration No. VD-15205-11) is an antibiotic ear drop, which is prescribed as routine treatment for children.
Thai Binh University of Medicine and Pharmacy, Thai Binh Medical University Hospital and Thai Binh Children's Hospital, Thái Bình
Lead Sponsor
Thai Binh University of Medicine and Pharmacy
OTHER
Anabio R&D
INDUSTRY