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

NCT05929599 | Active Not Recruiting DMC

• 2 other identifiers: HH1241No.1241/BVNTW-HDDD
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Tract Infections; Pneumonia; Respiratory Syncytial Virus (RSV)

Keywords

Respiratory Syncytial Virus (RSV); Acute Respiratory Tract Infections (ARTIs); Children; Oxy therapy; Nasal-spraying probiotics; Co-infection bacteria; Viral load; Cytokines; Bacillus spores

Outcome Measures

Primary Outcomes (3)

• Percentage of patients with free respiratory symptoms

  Percentage (%) of RSV-infected patients with free respiratory symptoms including runny nose, chest depression, difficulty breathing, dry rales, and moist rales...

  Day 0 to day 10

• Number of days requiring oxygen therapy

  Number of days the patient requires oxygen therapy intervention.

  Day 0 to day 10

• Number of days using antibiotics

  Number of days the patient using antibiotics

  Day 0 to day 10

Secondary Outcomes (8)

• Patient's breath

  Day 0 to day 3

• Patient's pulse

  Day 0 to day 3

• Patient's pulse oxygen (SpO2)

  Day 0 to day 3

• Change RSV concentration

  Day 0 and day 3

• Change co-infection bacterial concentrations

  Day 0 and day 3

Study Arms (2)

Control

PLACEBO COMPARATOR

Control group receives the routine treatment and uses 0.9% NaCl physiological saline: Routine treatment is as follows: * Treatment medications: antipyretic paracetamol, antibiotics following the treatment protocol for community-acquired pneumonia in children by the Ministry of Health, and antibiotics with susceptibility results, such as Amoxicillin, Augmentin, or Benzylpenicillin. In cases of severe pneumonia, the following antibiotics may be used: Benzylpenicillin + Gentamicin; Cephalosporins (Cefotaxime, Ceftriaxone) + Amikacin; Oxacillin, Bristopen, Vancomycin if Staphylococcal pneumonia is suspected. * Oxygen therapy: Indicated for all cases of severe pneumonia when SpO2 \<92%. Use an oxygen mask or nasal cannula.

Drug: 0.9% NaCl physiological saline

Navax

EXPERIMENTAL

Navax group receives the routine treatment and uses NaCl 0.9% plus B. subtilis and B. clausii at 5 billion CFU/5 mL (LiveSpo®️ Navax): Routine treatment is as follows: * Treatment medications: antipyretic paracetamol, antibiotics following the treatment protocol for community-acquired pneumonia in children by the Ministry of Health, and antibiotics with susceptibility results, such as Amoxicillin, Augmentin, or Benzylpenicillin. In cases of severe pneumonia, the following antibiotics may be used: Benzylpenicillin + Gentamicin; Cephalosporins (Cefotaxime, Ceftriaxone) + Amikacin; Oxacillin, Bristopen, Vancomycin if Staphylococcal pneumonia is suspected. * Oxygen therapy: Indicated for all cases of severe pneumonia when SpO2 \<92%. Use an oxygen mask or nasal cannula.

Combination Product: LiveSpo Navax

Interventions

0.9% NaCl physiological saline DRUG

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.

Also known as: Registration number: VD-32723-19

Control

LiveSpo Navax COMBINATION_PRODUCT

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.

Also known as: Registration number: No.210001337/PCBA-HN

Navax

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children (male/female) aged from 1 to 24 months.
• Hospitalization due to pneumonia.
• RSV is positive by rapid test.
• Bacterial co-infection (Yes or No).
• Oxygen therapy (Yes or No).
• Parents of the pediatric patient agree to participate in the study, explain and sign the research consent form.

You may not qualify if:

• Children with underlying medical conditions (congenital heart disease, airway malformation).
• Hospital-acquired pneumonia.
• Newborn babies.
• Have a history of drug allergy.
• Discharged before day 3.
• Lost to follow-up.
• Withdrawn from the trial.
• Continuing in the trial but missing data.
• Meeting the criteria for psychiatric disorders other than depression and/or anxiety.

Sponsors & Collaborators

• National Children's Hospital, Vietnam: lead
• Anabio R&D: collaborator

Study Sites (1)

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

Hà Nội, 10000, Vietnam

Location

Related Publications (19)

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  PMID: 40770421 DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hoa T Le, MSc. MD

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

  PRINCIPAL INVESTIGATOR

• Hanh TH Le, PhD. MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: LiveSpo Navax and placebo 0.9% NaCl physiological saline are indistinguishable regarding taste and smell. The color and turbidity of LiveSpo Navax suspension are unrecognizable to investigators, nurses, patient's parents, and patients except for the PI, principal nurses, and analyzer, due to opaque plastic containers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Center for Pulmonology and Respiratory Care, Vietnam National Children's Hospital

Model Details: Blind, randomized, and controlled clinical trial

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 3, 2023
• Study Start: July 5, 2023
• Primary Completion: July 27, 2024
• Study Completion: March 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a study protocol, informed consent form (ICF), clinical study peport (CSR). For more information or to submit a request, please contact anabio.rd2021@gmail.com

Locations

VN (1)