Pneumonia Clinical Trial
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
Verified date | July 2023 |
Source | National Children's Hospital, Vietnam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | July 2024 |
Est. primary completion date | May 27, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 24 Months |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Vietnam | The Center for Pulmonology and Respiratory Care, Vietnam National Children's Hospital | Ha Noi |
Lead Sponsor | Collaborator |
---|---|
National Children's Hospital, Vietnam | Anabio R&D |
Vietnam,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 7 | |
Primary | Number of days requiring oxygen therapy | Number of days the patient requires oxygen therapy intervention. | Day 0 to day 7 | |
Secondary | Patient's breath | Monitoring the patient's breath (beat/min) on a daily basis during treatment | Day 0 to day 7 | |
Secondary | Patient's pulse | Monitoring the patient's pulse (beat/min) on a daily basis during treatment | Day 0 to day 7 | |
Secondary | Patient's pulse oxygen (SpO2) | Monitoring the patient's pulse oxygen - SpO2 (%) on a daily basis during treatment | Day 0 to day 7 | |
Secondary | Change RSV concentration | 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) | Day 0 and day 3 | |
Secondary | Change co-infection bacterial concentrations | 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) | Day 0 and day 3 | |
Secondary | Change cytokines levels | Change cytokines levels (pg/mL) (e.g., tumor necrosis factor-a (TNF-a), interleukin-6 (IL-6), interleukin-8 (IL-8)...) in nasopharyngeal samples at day 3 (after treatment) compared with day 0 (before treatment) | Day 0 and day 3 | |
Secondary | Change Immunoglobulin A (IgA) level | Change IgA level (mg/mL) in nasopharyngeal samples at day 3 (after treatment) compared with day 0 (before treatment) | Day 0 and day 3 | |
Secondary | Change the nasal microbiota (If any) | 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). | Day 0 and day 3 |
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