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

Summary

Respiratory syncytial virus (RSV) infection and bacterial co-infection are the most common causes of pneumonia. Currently, there is no vaccine available for RSV prevention, and the use of the antiviral medication ribavirin is not widely recommended for children. Therefore, the primary treatment approach follows the general protocol for pneumonia, and oxygen therapy is recommended for all cases of pneumonia with respiratory failure. However, in children, the treatment of RSV and bacterial pneumonia remains supportive to prevent bacterial co-infection and respiratory failure. Probiotics have emerged as promising and safe options for supporting the treatment of acute respiratory tract infections (ARTIs) and reducing dependence on antibiotics in recent years. In this study, investigators propose that the direct administration of probiotics through a nasal spray can offer rapid and effective symptomatic treatment for children with pneumonia who require oxygen therapy due to RSV and bacterial co-infections.

The aim of the study is to evaluate the effectiveness of nasal-spraying probiotics containing spores of two bacterial strains, Bacillus subtilis and Bacillus clausii (LiveSpo Navax), in preventing and supporting the treatment of severe pneumonia in children (who require oxygen therapy) caused by RSV infection and bacterial co-infection.

Study population: The sample size was 100, and the study was conducted at the Vietnam National Children's Hospital.

Description of Study Intervention: All 100 eligible patients were randomly divided into two groups (n = 50/each): Patients in the Control group received routine treatment and were administered 0.9% NaCl physiological saline 3 times/day, while the patients in the Navax group received LiveSpo Navax 3 times/day in addition to the same standard of care treatment. The standard treatment regimen typically lasts for 5-7 days, but its duration can be extended based on the severity of the patient's respiratory failure.

Study duration: 12 months.

Conditions

• Acute Respiratory Tract Infections
• Pneumonia
• Respiratory 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.

Sponsors & Collaborators

• Anabio R&D

  collaborator INDUSTRY

• National Children's Hospital, Vietnam

  lead OTHER

Principal Investigators

• Hoa T Le, MSc. MD · The Center for Pulmonology and Respiratory Care, Vietnam National Children's Hospital

• Hanh TH Le, PhD. MD · The Center for Pulmonology and Respiratory Care, Vietnam National Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

24 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-05

Primary Completion

2024-07-27

Completion

2025-03-31

Countries

• Vietnam

Study Locations