Efficacy of LiveSpo Navax in Supportive Treatment of Pneumonia in Children With RSV and Bacterial Co-infections
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ClinicalTrials.gov Identifier: NCT05929599 |
Recruitment Status :
Recruiting
First Posted : July 3, 2023
Last Update Posted : July 6, 2023
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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.
Condition or disease | Intervention/treatment | Phase |
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Acute Respiratory Tract Infections Pneumonia Respiratory Syncytial Virus (RSV) | Drug: 0.9% NaCl physiological saline Combination Product: LiveSpo Navax | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Blind, randomized, and controlled clinical trial |
Masking: | Triple (Participant, Care Provider, Investigator) |
Masking Description: | 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. |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | July 5, 2023 |
Estimated Primary Completion Date : | April 2024 |
Estimated Study Completion Date : | July 2024 |
Arm | Intervention/treatment |
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Placebo Comparator: Control
Control group receives the routine treatment and uses 0.9% NaCl physiological saline: Routine treatment is as follows:
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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.
Other Name: Registration number: VD-32723-19 |
Experimental: Navax
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:
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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.
Other Name: Registration number: No.210001337/PCBA-HN |
- Percentage of patients with free respiratory symptoms [ Time Frame: Day 0 to day 7 ]Percentage (%) of RSV-infected patients with free respiratory symptoms including runny nose, chest depression, difficulty breathing, dry rales, and moist rales...
- Number of days requiring oxygen therapy [ Time Frame: Day 0 to day 7 ]Number of days the patient requires oxygen therapy intervention.
- Patient's breath [ Time Frame: Day 0 to day 7 ]Monitoring the patient's breath (beat/min) on a daily basis during treatment
- Patient's pulse [ Time Frame: Day 0 to day 7 ]Monitoring the patient's pulse (beat/min) on a daily basis during treatment
- Patient's pulse oxygen (SpO2) [ Time Frame: Day 0 to day 7 ]Monitoring the patient's pulse oxygen - SpO2 (%) on a daily basis during treatment
- Change RSV concentration [ Time Frame: Day 0 and day 3 ]Change concentration of respiratory syncytial virus in nasopharyngeal samples, as indicated by real-time PCR threshold cycle (Ct) value at day 3 (after treatment) compared with day 0 (before treatment)
- Change co-infection bacterial concentrations [ Time Frame: Day 0 and day 3 ]Change concentration of Co-infection bacterial in nasopharyngeal samples, as indicated by real-time PCR threshold cycle (Ct) value at day 3 (after treatment) compared with day 0 (before treatment)
- Change cytokines levels [ Time Frame: Day 0 and day 3 ]Change cytokines levels (pg/mL) (e.g., tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), interleukin-8 (IL-8)...) in nasopharyngeal samples at day 3 (after treatment) compared with day 0 (before treatment)
- Change Immunoglobulin A (IgA) level [ Time Frame: Day 0 and day 3 ]Change IgA level (mg/mL) in nasopharyngeal samples at day 3 (after treatment) compared with day 0 (before treatment)
- Change the nasal microbiota (If any) [ Time Frame: Day 0 and day 3 ]Alter the nasal microbiota, as indicated by changes in the diversity of nasal microbial species based on the data analysis of next-generation sequencing (NGS) on day 3 (after treatment) compared to day 0 (before treatment).
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Ages Eligible for Study: | 1 Month to 24 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05929599
Contact: Hoa T Le, MSc.MD | (84) 9836222648 | hoayhn3004@gmail.com | |
Contact: Hanh TH Le, PhD. MD | (84) 985061996 | lehonghannhbvnhi@yahoo.com |
Vietnam | |
The Center for Pulmonology and Respiratory Care, Vietnam National Children's Hospital | Recruiting |
Ha Noi, Vietnam, 10000 | |
Contact: Hoa T Le, MSc.MD (84) 983622648 hoayhn3004@gmail.com | |
Contact: Hanh TH Le, PhD. MD (84) 985061996 lehonghannhbvnhi@yahoo.com | |
Principal Investigator: Thuy TB Phung, PhD. | |
Principal Investigator: Anh TV Nguyen, PhD. | |
Sub-Investigator: Huyen T Bui, MSc |
Principal Investigator: | Hoa T Le, MSc. MD | The Center for Pulmonology and Respiratory Care, Vietnam National Children's Hospital | |
Study Director: | Hanh TH Le, PhD. MD | The Center for Pulmonology and Respiratory Care, Vietnam National Children's Hospital |
Responsible Party: | Le Thi Hoa, Principal Investigator, Center for Pulmonology and Respiratory Care, Vietnam National Children's Hospital, National Children's Hospital, Vietnam |
ClinicalTrials.gov Identifier: | NCT05929599 |
Other Study ID Numbers: |
HH1241 No.1241/BVNTW-HDDD ( Other Identifier: Vietnam National Children's Hospital ) |
First Posted: | July 3, 2023 Key Record Dates |
Last Update Posted: | July 6, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Data or samples share that will be coded, with no PHI include. Approval of the request and execution of all applicable agreements (i.e., a material transfer agreement) are prerequisites to the sharing of data with the requesting party. |
Supporting Materials: |
Study Protocol Informed Consent Form (ICF) Clinical Study Report (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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Respiratory Syncytial Virus (RSV) Acute Respiratory Tract Infections (ARTIs) Children Oxy therapy Nasal-spraying probiotics |
Co-infection bacteria Viral load Cytokines Bacillus spores |
Infections Communicable Diseases Pneumonia Respiratory Tract Infections Coinfection |
Disease Attributes Pathologic Processes Lung Diseases Respiratory Tract Diseases |