LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media

NACompletedINTERVENTIONAL
Enrollment

175

Participants

Timeline

Start Date

October 28, 2021

Primary Completion Date

April 5, 2024

Study Completion Date

August 1, 2024

Conditions
Upper Respiratory Tract Infections
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

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (1)

Unknown

Thai Binh University of Medicine and Pharmacy, Thai Binh Medical University Hospital and Thai Binh Children's Hospital, Thái Bình

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Thai Binh University of Medicine and Pharmacy

OTHER

lead

Anabio R&D

INDUSTRY

NCT05804123 - LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media | Biotech Hunter | Biotech Hunter