Efficacy of LiveSpo Navax in Supportive Treatment of Pneumonia in Children With RSV and Bacterial Co-infections
Efficacy of Nasal-sprayed Probiotics Containing Bacillus Subtilis and Bacillus Clausii (LiveSpo Navax) in the Supportive Treatment of Pneumonia in Children Infected With Viral Respiratory Syncytial Virus (RSV) and Bacterial Co-infections
Other study identifiers
Sponsor study identifier
Secondary identifiers
OTHER · Vietnam National Children's Hospital
interventional
120
1 country
1
Study Start
July 5, 2023
Actual (reported)Primary Completion
July 27, 2024
Actual (reported)Study Completion
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Brief 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- active not recruiting
- Actual enrollment (reported)
- 120 participants
- Study completion date
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Listed locations
- 1 countries · 1 sites
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
June 12, 2023
Actual (reported)First Posted
July 3, 2023
Actual (reported)Study Start
July 5, 2023
Actual (reported)Primary Completion
July 27, 2024
Actual (reported)Study Completion
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Last Updated
- January 22, 2025
- Status Verified
- January 2025
- Last Update Submitted
- January 19, 2025