Effects of Nasal-spraying LiveSpo Navax in Treatment of Influenza Virus in Children
NCT ID: NCT05378022
Last Updated: 2022-05-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
70 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-12-21
Study Completion Date
2022-04-22
Brief Summary
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Acute Respiratory Tract Infections (ARTIs) in children are common diseases, with influenza virus types A and B is one of the main causes of serious symptoms in young children. Although an influenza vaccine is available, influenza vaccination requires annual injections, which made it difficult for young children to get effectively immunized. Moreover, antiviral nucleotide drugs including Tamiflu (oseltamivir) are unsafe for young children and are recommended only for high-risk patients. Probiotics have emerged as promising safe candidates for supportive treatment of ARTIs and reduction of antibiotic dependence in recent years. Here, investigators propose that direct spraying of probiotics into the nose can be a fast and effective symptomatic treatment for ARTIs due to influenza virus.
The aim of the study about to evaluate the effectiveness of nasal-spraying probiotics containing spores of two bacterial strains, Bacillus subtilis and Bacillus clausii in preventing and supporting the treatment of children having acute respiratory symptoms due to influenza infection.
Study Population: sample size is 70. Description of Sites: the study is carried out at Vietnam National Children's Hospital.
Description of Study Intervention: totally 70 eligible patients are divided randomly into 2 groups (n = 35/group each): Patients in Control group received the routine treatment and three times per day 0.9% NaCl physiological saline while the patients in the Navax group received three times per day LiveSpo Navax in addition to the same standard of care treatment. The standard treatment regimen is 2-5 days but can be extended further depending on the severity of the patient's respiratory failure.
Study duration: 15 months
The aim of the study about to evaluate the effectiveness of nasal-spraying probiotics containing spores of two bacterial strains, Bacillus subtilis and Bacillus clausii in preventing and supporting the treatment of children having acute respiratory symptoms due to influenza infection.
Study Population: sample size is 70. Description of Sites: the study is carried out at Vietnam National Children's Hospital.
Description of Study Intervention: totally 70 eligible patients are divided randomly into 2 groups (n = 35/group each): Patients in Control group received the routine treatment and three times per day 0.9% NaCl physiological saline while the patients in the Navax group received three times per day LiveSpo Navax in addition to the same standard of care treatment. The standard treatment regimen is 2-5 days but can be extended further depending on the severity of the patient's respiratory failure.
Study duration: 15 months
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Detailed Description
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Influenza virus types A and B is the common virus that causes Acute Respiratory Tract Infections (ARTIs) with a high risk of bronchiolitis for young children and infants. Influenza-infection symptoms range from mild fever, cough, runny nose, and wheezing to severe symptoms such as fast pulse, fast breathing, and respiratory failure. In a systematic review and meta-analysis of the global burden of seasonal influenza respiratory infections in young children, they estimated that 28.000 - 111.500 children under the age of 5 die as a result of influenza infections in 2008, of which 99% of these deaths occurred in developing countries. Influenza vaccination requires annual injections, which made it difficult for young children to get effectively immunized. Moreover, antiviral nucleotide drugs including Tamiflu (oseltamivir) are unsafe for young children and are recommended only for high-risk patients. Probiotics have emerged as promising safe candidates for supportive treatment of ARTIs and reduction of antibiotic dependence in recent years. However, the use of oral administrative probiotics as functional foods is effective only for mild symptoms and not applicable for Acute RTIs (ARTIs). Here, investigators propose that direct spraying of probiotics into the nose can be a fast and effective symptomatic treatment for ARTIs.
The objective was to investigate the symptomatic treatment effects of probiotic product LiveSpo Navax, as a liquid-suspension form containing Bacillus spores of safe B. subtilis ANA4 and B. clausii ANA39 strains, in children having acute respiratory diseases caused by influenza virus, investigators evaluation of improved efficacy and reduced treatment time of LiveSpo Navax in influenza-infected children; and measurement of changes in influenza viral load, co-infectious bacterial concentrations, and major cytokine indicators in the nasopharyngeal samples before and after 2 days using LiveSpo Navax.
Methods: A randomized, blind, and controlled clinical trial is conducted. The patient's parents are required to provide the following information about their children: full name, sex, age, obstetric history, vaccination history, and antibiotic use history… After informed consent, 70 patients with ARTIs due to influenza virus will be randomized into 2 groups (n = 35/group): the control group (named "Control" group) uses 0.9% NaCl physiological saline and an experimental group (named the "Navax" group) use the probiotics LiveSpo Navax. The patient is given a coded spray in the form of a blind sample to ensure the objectivity of the study. The clinical follow-up will be 5 days, nasopharyngeal samples will be collected at day 0 and day 2 to evaluate potential reductions in viral load and co-infection bacteria, as well as modulation of overreacted cytokine release and the presence of probiotic spores in the patient's nasal mucosa.
Real-time PCR for detection of microorganism in nasopharyngeal samples: semi-quantitative assays for measuring changes in influenza viral load and co-infection bacterial concentrations is conducted by the real-time RT-PCR/PCR routine protocol which has been standardized under ISO 15189:2012 criteria and used in Vietnam National Children's Hospital. Detection of B. subtilis ANA4 and B. clausii ANA39 are also conducted by real-time PCR SYBR Green that has been standardized under ISO 17025: 2017 standard and routinely in the Key Laboratory of Enzyme and Protein Technology, VNU University of Science.
ELISA assays for cytokine levels: pro-inflammatory cytokines levels (pg/mL) including interleukin (IL-6, IL-8) and TNF-alpha are quantified using an enzyme-linked immunosorbent assay kit (ELISA) according to the manufacturer's instructions.
During treatment, patients are monitored daily for typical clinical symptoms of Flu-induced respiratory tract infections, including runny nose, fever, dry rales, moist rales, body temperature (oC), oxymetry (SpO2) (%), pulse (beats/min), and breath (beats/min) until discharged. The patients' health conditions are observed by doctors and nurses, and their pieces of information are filled into medical records. During this study, parents' patients are asked to abstain from consumption for their children of other probiotics, either via nasal spray or oral administration, and refrain from cleaning nose for their children with other 0.9% NaCl physiological saline sprayers.
Data collection and statistical analysis: individual medical records are collected, and the patient's information is then gathered and systematized in a data set. The efficacy of LiveSpo Navax is evaluated and compared to 0.9% NaCl physiological saline based on the following clinical and sub-clinical criteria obtained in Navax and Control groups: (i) the symptomatic-relieving day; (ii) the reduction levels (2\^△Ct) of influenza viral load and co-infection bacteria concentrations. △Ct for target genes is calculated as Ct (threshold cycle) at day 2 - Ct at day 0 while Ct of internal control is adjusted to be equal among all samples; (iii) the reduction levels of IL-6, IL-8, and TNF-alpha cytokines. The tabular analysis is performed on dichotomous variables using the χ2 test or Fisher's exact test when the expected value of any cell is below five. Continuous variables are compared using either the Wilcoxon test, t-test, or the Mann-Whitney test when data are not normally distributed. The correlations among the variables are assessed by Spearman's correlation analysis. Statistical and graphical analyses are performed on GraphPad Prism v8.4.3 software (GraphPad Software, CA, USA). The significance level of all analyzes is set at p \< 0.05. P-values.
Expected outcomes: (i) LiveSpo Navax alleviates influenza-infection symptoms about 30% more effectively, as indicated by 90% of patients using LiveSpo Navax (Navax group) are symptom-free at day 2-5 of intervention depending on symptoms, compared to 60% of patients in Control group; (ii) Patients in Navax group has more significant reductions in influenza viral load (\>10 fold) than patients in Control group at day 2 of intervention.
The objective was to investigate the symptomatic treatment effects of probiotic product LiveSpo Navax, as a liquid-suspension form containing Bacillus spores of safe B. subtilis ANA4 and B. clausii ANA39 strains, in children having acute respiratory diseases caused by influenza virus, investigators evaluation of improved efficacy and reduced treatment time of LiveSpo Navax in influenza-infected children; and measurement of changes in influenza viral load, co-infectious bacterial concentrations, and major cytokine indicators in the nasopharyngeal samples before and after 2 days using LiveSpo Navax.
Methods: A randomized, blind, and controlled clinical trial is conducted. The patient's parents are required to provide the following information about their children: full name, sex, age, obstetric history, vaccination history, and antibiotic use history… After informed consent, 70 patients with ARTIs due to influenza virus will be randomized into 2 groups (n = 35/group): the control group (named "Control" group) uses 0.9% NaCl physiological saline and an experimental group (named the "Navax" group) use the probiotics LiveSpo Navax. The patient is given a coded spray in the form of a blind sample to ensure the objectivity of the study. The clinical follow-up will be 5 days, nasopharyngeal samples will be collected at day 0 and day 2 to evaluate potential reductions in viral load and co-infection bacteria, as well as modulation of overreacted cytokine release and the presence of probiotic spores in the patient's nasal mucosa.
Real-time PCR for detection of microorganism in nasopharyngeal samples: semi-quantitative assays for measuring changes in influenza viral load and co-infection bacterial concentrations is conducted by the real-time RT-PCR/PCR routine protocol which has been standardized under ISO 15189:2012 criteria and used in Vietnam National Children's Hospital. Detection of B. subtilis ANA4 and B. clausii ANA39 are also conducted by real-time PCR SYBR Green that has been standardized under ISO 17025: 2017 standard and routinely in the Key Laboratory of Enzyme and Protein Technology, VNU University of Science.
ELISA assays for cytokine levels: pro-inflammatory cytokines levels (pg/mL) including interleukin (IL-6, IL-8) and TNF-alpha are quantified using an enzyme-linked immunosorbent assay kit (ELISA) according to the manufacturer's instructions.
During treatment, patients are monitored daily for typical clinical symptoms of Flu-induced respiratory tract infections, including runny nose, fever, dry rales, moist rales, body temperature (oC), oxymetry (SpO2) (%), pulse (beats/min), and breath (beats/min) until discharged. The patients' health conditions are observed by doctors and nurses, and their pieces of information are filled into medical records. During this study, parents' patients are asked to abstain from consumption for their children of other probiotics, either via nasal spray or oral administration, and refrain from cleaning nose for their children with other 0.9% NaCl physiological saline sprayers.
Data collection and statistical analysis: individual medical records are collected, and the patient's information is then gathered and systematized in a data set. The efficacy of LiveSpo Navax is evaluated and compared to 0.9% NaCl physiological saline based on the following clinical and sub-clinical criteria obtained in Navax and Control groups: (i) the symptomatic-relieving day; (ii) the reduction levels (2\^△Ct) of influenza viral load and co-infection bacteria concentrations. △Ct for target genes is calculated as Ct (threshold cycle) at day 2 - Ct at day 0 while Ct of internal control is adjusted to be equal among all samples; (iii) the reduction levels of IL-6, IL-8, and TNF-alpha cytokines. The tabular analysis is performed on dichotomous variables using the χ2 test or Fisher's exact test when the expected value of any cell is below five. Continuous variables are compared using either the Wilcoxon test, t-test, or the Mann-Whitney test when data are not normally distributed. The correlations among the variables are assessed by Spearman's correlation analysis. Statistical and graphical analyses are performed on GraphPad Prism v8.4.3 software (GraphPad Software, CA, USA). The significance level of all analyzes is set at p \< 0.05. P-values.
Expected outcomes: (i) LiveSpo Navax alleviates influenza-infection symptoms about 30% more effectively, as indicated by 90% of patients using LiveSpo Navax (Navax group) are symptom-free at day 2-5 of intervention depending on symptoms, compared to 60% of patients in Control group; (ii) Patients in Navax group has more significant reductions in influenza viral load (\>10 fold) than patients in Control group at day 2 of intervention.
Conditions
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Acute Respiratory Tract Infections
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Blind, randomized, and controlled clinical trial
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
LiveSpo Navax and placebo 0.9% NaCl physiological saline are indistinguishable regarding taste and smell. The color and turbidity of LiveSpo Navax suspension is unrecognizable to investigators except the PI and analyzer, nurses, patient's parents, and patients due to opaque plastic container.
Study Groups
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Control
Control group receives the routine treatment and uses 0.9% NaCl physiological saline:
Routine treatment is as follows:
* Oral administrative drugs: antipyretic paracetamol (Efferegant®); expectorant Carbocysteine (Carbothiol®); antiviral Oseltamivir phosphate (Tamiflu®); antibiotics e.g. cefotaxim (Goldcefo®), Amoxicillin / clavulanic acid (Augmentin®) based on the results of antibiotic susceptibility test.
* Aerosol therapy: bronchodilator e.g. salbutamol (Ventolin ®️inhaler) or budesonide (Pulmicort ®️Respules).
Group Type
PLACEBO_COMPARATOR
0.9% NaCl physiological saline
Intervention Type
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.
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:
Oral administrative drugs: antipyretic paracetamol (Efferegant®); expectorant Carbocysteine (Carbothiol®); antiviral Oseltamivir phosphate (Tamiflu®); antibiotics e.g. cefotaxime (Goldcefo®), Amoxicillin / clavulanic acid (Augmentin®) based on the results of antibiotic susceptibility test.
\- Aerosol therapy: bronchodilator e.g. salbutamol (Ventolin ®️inhaler) or budesonide (Pulmicort ®️Respules).
Group Type
EXPERIMENTAL
LiveSpo Navax
Intervention Type
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.
Interventions
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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.
Intervention Type
COMBINATION_PRODUCT
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.
Intervention Type
DRUG
Other Intervention Names
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Registration number: No.210001337/PCBA-HN
Registration number: VD-32723-19
Eligibility Criteria
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Inclusion Criteria
* Children (male/female) aged from 4 months to 7 years
* Admitted to hospital due to upper respiratory infection
* Influenza A and B positive by rapid test
* Parents of the pediatric patient agree to participate in the study, explain and sign the research consent form.
* Admitted to hospital due to upper respiratory infection
* Influenza A and B positive by rapid test
* Parents of the pediatric patient agree to participate in the study, explain and sign the research consent form.
Exclusion Criteria
* Newborn babies
* Having a history of drug allergies
* Need oxygen therapy
* Discharged before day 2
* 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.
* Having a history of drug allergies
* Need oxygen therapy
* Discharged before day 2
* 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.
Minimum Eligible Age
4 Months
Maximum Eligible Age
7 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Children's Hospital, Vietnam
OTHER
Sponsor Role
lead
Responsible Party
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Tran Thanh Tu
Vice Director of International Center, Vietnam National Children's Hospital
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Tu T Tran, PhD. MD.
Role: PRINCIPAL_INVESTIGATOR
International Center, Vietnam National Children's Hospital
Locations
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International Center, Vietnam National Children's Hospital
Hanoi, , Vietnam
Site Status
Countries
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Vietnam
References
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Doyle JD, Campbell AP. Pediatric influenza and illness severity: what is known and what questions remain? Curr Opin Pediatr. 2019 Feb;31(1):119-126. doi: 10.1097/MOP.0000000000000721.
Reference Type
BACKGROUND
Sellers SA, Hagan RS, Hayden FG, Fischer WA 2nd. The hidden burden of influenza: A review of the extra-pulmonary complications of influenza infection. Influenza Other Respir Viruses. 2017 Sep;11(5):372-393. doi: 10.1111/irv.12470.
Reference Type
BACKGROUND
Dawood FS, Chaves SS, Perez A, Reingold A, Meek J, Farley MM, Ryan P, Lynfield R, Morin C, Baumbach J, Bennett NM, Zansky S, Thomas A, Lindegren ML, Schaffner W, Finelli L; Emerging Infections Program Network. Complications and associated bacterial coinfections among children hospitalized with seasonal or pandemic influenza, United States, 2003-2010. J Infect Dis. 2014 Mar 1;209(5):686-94. doi: 10.1093/infdis/jit473. Epub 2013 Aug 28.
Reference Type
BACKGROUND
Eccles R. Understanding the symptoms of the common cold and influenza. Lancet Infect Dis. 2005 Nov;5(11):718-25. doi: 10.1016/S1473-3099(05)70270-X.
Reference Type
BACKGROUND
COMMITTEE ON INFECTIOUS DISEASES. Recommendations for Prevention and Control of Influenza in Children, 2021-2022. Pediatrics. 2021 Oct;148(4):e2021053745. doi: 10.1542/peds.2021-053745. Epub 2021 Sep 7.
Reference Type
BACKGROUND
Bustinduy AL, Sutherland LJ, Chang-Cojulun A, Malhotra I, DuVall AS, Fairley JK, Mungai PL, Muchiri EM, Mutuku FM, Kitron U, King CH. Age-Stratified Profiles of Serum IL-6, IL-10, and TNF-alpha Cytokines Among Kenyan Children with Schistosoma haematobium, Plasmodium falciparum, and Other Chronic Parasitic Co-Infections. Am J Trop Med Hyg. 2015 May;92(5):945-51. doi: 10.4269/ajtmh.14-0444. Epub 2015 Mar 9.
Reference Type
BACKGROUND
Diaz PV, Valdivia G, Gaggero AA, Bono MR, Zepeda G, Rivas M, Uasapud P, Pinto RA, Boza ML, Guerrero J. Pro-Inflammatory Cytokines in Nasopharyngeal Aspirate From Hospitalized Children With Respiratory Syncytial Virus Infection With or Without Rhinovirus Bronchiolitis, and Use of the Cytokines as Predictors of Illness Severity. Medicine (Baltimore). 2015 Sep;94(39):e1512. doi: 10.1097/MD.0000000000001512.
Reference Type
BACKGROUND
Duvigneau S, Sharma-Chawla N, Boianelli A, Stegemann-Koniszewski S, Nguyen VK, Bruder D, Hernandez-Vargas EA. Hierarchical effects of pro-inflammatory cytokines on the post-influenza susceptibility to pneumococcal coinfection. Sci Rep. 2016 Nov 22;6:37045. doi: 10.1038/srep37045.
Reference Type
BACKGROUND
Vazquez Y, Gonzalez L, Noguera L, Gonzalez PA, Riedel CA, Bertrand P, Bueno SM. Cytokines in the Respiratory Airway as Biomarkers of Severity and Prognosis for Respiratory Syncytial Virus Infection: An Update. Front Immunol. 2019 Jun 4;10:1154. doi: 10.3389/fimmu.2019.01154. eCollection 2019.
Reference Type
BACKGROUND
Pandolfi E, Panera N, Alisi A, Carloni E, Russo L, Campagna I, Rizzo C, Concato C, Linardos G, Piccioni L, Jackson S, Villani A, Midulla F, Tozzi AE. Cytokine expression patterns in hospitalized children with Bordetella pertussis, Rhinovirus or co-infection. Sci Rep. 2021 May 26;11(1):10948. doi: 10.1038/s41598-021-89538-0.
Reference Type
BACKGROUND
Hu W, DeMarcus LS, Sjoberg PA, Robbins AS. Inactivated influenza vaccine effectiveness among department of defense beneficiaries aged 6 months-17 years, 2016-2017 through 2019-2020 influenza seasons. PLoS One. 2021 Aug 27;16(8):e0256165. doi: 10.1371/journal.pone.0256165. eCollection 2021.
Reference Type
BACKGROUND
Smith JR, Ariano RE, Toovey S. The use of antiviral agents for the management of severe influenza. Crit Care Med. 2010 Apr;38(4 Suppl):e43-51. doi: 10.1097/CCM.0b013e3181c85229.
Reference Type
BACKGROUND
Sugaya N, Tamura D, Yamazaki M, Ichikawa M, Kawakami C, Kawaoka Y, Mitamura K. Comparison of the clinical effectiveness of oseltamivir and zanamivir against influenza virus infection in children. Clin Infect Dis. 2008 Aug 1;47(3):339-45. doi: 10.1086/589748.
Reference Type
BACKGROUND
American Academy of Pediatrics Committee on Infectious Diseases. Antiviral therapy and prophylaxis for influenza in children. Pediatrics. 2007 Apr;119(4):852-60. doi: 10.1542/peds.2007-0224.
Reference Type
BACKGROUND
Nicholson KG, Aoki FY, Osterhaus AD, Trottier S, Carewicz O, Mercier CH, Rode A, Kinnersley N, Ward P. Efficacy and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial. Neuraminidase Inhibitor Flu Treatment Investigator Group. Lancet. 2000 May 27;355(9218):1845-50. doi: 10.1016/s0140-6736(00)02288-1.
Reference Type
BACKGROUND
Oo C, Barrett J, Hill G, Mann J, Dorr A, Dutkowski R, Ward P. Pharmacokinetics and dosage recommendations for an oseltamivir oral suspension for the treatment of influenza in children. Paediatr Drugs. 2001;3(3):229-36. doi: 10.2165/00128072-200103030-00005.
Reference Type
BACKGROUND
Wooltorton E. Oseltamivir (Tamiflu) unsafe in infants under 1 year old. CMAJ. 2004 Feb 3;170(3):336. No abstract available.
Reference Type
BACKGROUND
Martin-Loeches I, van Someren Greve F, Schultz MJ. Bacterial pneumonia as an influenza complication. Curr Opin Infect Dis. 2017 Apr;30(2):201-207. doi: 10.1097/QCO.0000000000000347.
Reference Type
BACKGROUND
Slack MPE. The evidence for non-typeable Haemophilus influenzae as a causative agent of childhood pneumonia. Pneumonia (Nathan). 2017 Jun 25;9:9. doi: 10.1186/s41479-017-0033-2. eCollection 2017.
Reference Type
BACKGROUND
Dietl B, Henares D, Boix-Palop L, Munoz-Almagro C, Garau J, Calbo E. Related Factors to Streptococcus pneumoniae Invasive Infection and Clinical Manifestations: The Potential Role of Nasopharyngeal Microbiome. Front Med (Lausanne). 2021 Apr 20;8:650271. doi: 10.3389/fmed.2021.650271. eCollection 2021.
Reference Type
BACKGROUND
Harun AM, Noor NFM, Zaid A, Yusoff ME, Shaari R, Affandi NDN, Fadil F, Rahman MAA, Alam MK. The Antimicrobial Properties of Nanotitania Extract and Its Role in Inhibiting the Growth of Klebsiella pneumonia and Haemophilus influenza. Antibiotics (Basel). 2021 Aug 10;10(8):961. doi: 10.3390/antibiotics10080961.
Reference Type
BACKGROUND
Shahbazi R, Yasavoli-Sharahi H, Alsadi N, Ismail N, Matar C. Probiotics in Treatment of Viral Respiratory Infections and Neuroinflammatory Disorders. Molecules. 2020 Oct 22;25(21):4891. doi: 10.3390/molecules25214891.
Reference Type
BACKGROUND
Lehtoranta L, Pitkaranta A, Korpela R. Probiotics in respiratory virus infections. Eur J Clin Microbiol Infect Dis. 2014 Aug;33(8):1289-302. doi: 10.1007/s10096-014-2086-y. Epub 2014 Mar 18.
Reference Type
BACKGROUND
Rautava S, Salminen S, Isolauri E. Specific probiotics in reducing the risk of acute infections in infancy--a randomised, double-blind, placebo-controlled study. Br J Nutr. 2009 Jun;101(11):1722-6. doi: 10.1017/S0007114508116282. Epub 2008 Nov 6.
Reference Type
BACKGROUND
Anaya-Loyola MA, Enciso-Moreno JA, Lopez-Ramos JE, Garcia-Marin G, Orozco Alvarez MY, Vega-Garcia AM, Mosqueda J, Garcia-Gutierrez DG, Keller D, Perez-Ramirez IF. Bacillus coagulans GBI-30, 6068 decreases upper respiratory and gastrointestinal tract symptoms in healthy Mexican scholar-aged children by modulating immune-related proteins. Food Res Int. 2019 Nov;125:108567. doi: 10.1016/j.foodres.2019.108567. Epub 2019 Jul 21.
Reference Type
BACKGROUND
Kumpu M, Kekkonen RA, Kautiainen H, Jarvenpaa S, Kristo A, Huovinen P, Pitkaranta A, Korpela R, Hatakka K. Milk containing probiotic Lactobacillus rhamnosus GG and respiratory illness in children: a randomized, double-blind, placebo-controlled trial. Eur J Clin Nutr. 2012 Sep;66(9):1020-3. doi: 10.1038/ejcn.2012.62. Epub 2012 Jun 13.
Reference Type
BACKGROUND
Liu S, Hu P, Du X, Zhou T, Pei X. Lactobacillus rhamnosus GG supplementation for preventing respiratory infections in children: a meta-analysis of randomized, placebo-controlled trials. Indian Pediatr. 2013 Apr;50(4):377-81. doi: 10.1007/s13312-013-0123-z.
Reference Type
BACKGROUND
Wang X, Li Y, O'Brien KL, Madhi SA, Widdowson MA, Byass P, Omer SB, Abbas Q, Ali A, Amu A, Azziz-Baumgartner E, Bassat Q, Abdullah Brooks W, Chaves SS, Chung A, Cohen C, Echavarria M, Fasce RA, Gentile A, Gordon A, Groome M, Heikkinen T, Hirve S, Jara JH, Katz MA, Khuri-Bulos N, Krishnan A, de Leon O, Lucero MG, McCracken JP, Mira-Iglesias A, Moisi JC, Munywoki PK, Ourohire M, Polack FP, Rahi M, Rasmussen ZA, Rath BA, Saha SK, Simoes EA, Sotomayor V, Thamthitiwat S, Treurnicht FK, Wamukoya M, Yoshida LM, Zar HJ, Campbell H, Nair H; Respiratory Virus Global Epidemiology Network. Global burden of respiratory infections associated with seasonal influenza in children under 5 years in 2018: a systematic review and modelling study. Lancet Glob Health. 2020 Apr;8(4):e497-e510. doi: 10.1016/S2214-109X(19)30545-5. Epub 2020 Feb 20.
Reference Type
RESULT
Tran TT, Phung TTB, Tran DM, Bui HT, Nguyen PTT, Vu TT, Ngo NTP, Nguyen MT, Nguyen AH, Nguyen ATV. Efficient symptomatic treatment and viral load reduction for children with influenza virus infection by nasal-spraying Bacillus spore probiotics. Sci Rep. 2023 Sep 8;13(1):14789. doi: 10.1038/s41598-023-41763-5.
Reference Type
DERIVED
Other Identifiers
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No. 441/BVNTW-VNCSKTE
Identifier Type: OTHER
Identifier Source: secondary_id
2020S-06.2
Identifier Type: -
Identifier Source: org_study_id
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A Study of AK0529 in Infants Hospitalized With RSV
NCT02460016
TERMINATED
PHASE1
Efficacy and Safety of ZSP1273 in Children 2-11 Years Old With Influenza A
NCT07229807
ACTIVE_NOT_RECRUITING
PHASE3
Safety Study of GS-5806 to Treat Respiratory Syncytial Virus (RSV)
NCT01797419
WITHDRAWN
PHASE1
Oseltamivir for Influenza Lower Respiratory Tract Infection in Children Under One
NCT01546935
WITHDRAWN
PHASE2/PHASE3
Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections
NCT06363370
RECRUITING
PHASE3
Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19
NCT05124210
TERMINATED
PHASE2
A Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Suraxavir Marboxil for Suspension
NCT07113392
NOT_YET_RECRUITING
PHASE3
Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
NCT06784973
TERMINATED
PHASE2
Treatment of Influenza and ARVI in Children by Kagocel ®
NCT04651491
COMPLETED
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection
NCT02593851
TERMINATED
PHASE1
Antiviral Therapy for Influenza A H1N1
NCT00985582
COMPLETED
Pharmacokinetics，Safety and Efficacy of ZSP1273 in Children 2-17 Years Old With Influenza A
NCT06656026
COMPLETED
PHASE2
Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Peramivir in Children With Influenza
NCT01063933
WITHDRAWN
PHASE1/PHASE2
Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza
NCT02369159
COMPLETED
PHASE3
Different Regimens in Influenza Postexposure Chemoprophylaxis in Children
NCT04297462
UNKNOWN
NA
A Study Assessing Safety, Tolerability, and Efficacy of INNA-051 in Preventing Respiratory Illness Due to Viral Infections in Healthy Adults 18 to 45 Years of Age
NCT07222670
RECRUITING
PHASE2
Study to Assess the Tolerability, Safety and Efficacy of GP681 Powder for Oral Suspension
NCT06643156
COMPLETED
PHASE1
Peginterferon α-2b Injection for Aerosol Therapy in Pediatric Respiratory Syncytial Virus Pneumonia
NCT06881056
RECRUITING
NA
Oseltamivir Treatment for Children Less Than 24 Months of Age With Influenza
NCT00391768
COMPLETED
PHASE1/PHASE2
Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
NCT00593502
COMPLETED
PHASE4
Efficacy of Aerosol Combination Therapy of 13 Cis Retinoic Acid and Captopril for Treating Covid-19 Patients Via Indirect Inhibition of Transmembrane Protease, Serine 2 (TMPRSS2)
NCT04578236
UNKNOWN
PHASE2
Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza
NCT02014649
TERMINATED
PHASE1/PHASE2