Respiratory InfectionMINIPARNCT06556420
Analysis of Nasopharyngeal Microbiota in Patients With Respiratory Infections
An observational study of Respiratory Infection, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Respiratory tract infections represent the most frequent infectious pathology in community environments and when of bacterial origin, imply a morbid state generally supported by a pathogenic bacterial species predominant on the commensal flora of the airways. Read more about this study
- Who is it for?
- Ages 0 to 20 years
- Conditions the study is for
- Respiratory Infection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 15 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who access the Pediatric Emergency Department with respiratory symptoms attributable to acute respiratory infection attributable to a bacterial and/or viral nature (diagnosed through nasopharyngeal swab as per normal clinical practice), who have given their informed consent to participate in this study. Subjects accessing the Pediatric Emergency Department who will perform a nasopharyngeal swab, as per normal clinical practice, with a negative result will also be included in the study as controls, considering the same exclusion criteria reported below. Informed consent will therefore be acquired upon entry to the Pediatric Emergency Department and in relation to the outcome of the nasopharyngeal swab the subjects will then be stratified into groups.
Who may be able to join
- age 0-20 years
- signs and/or symptoms of acute respiratory tract infection such as cold, pharyngitis, laryngitis, tracheitis, otitis, epiglottitis, laryngotracheitis, bronchitis and pneumonia.
Who cannot join
- antibiotic therapies in the last 30 days
- treatments with prebiotics or probiotics in the last 60 days (in particular containing Streptococcus salivarius)
- hormone therapies in the last 60 days
- local therapies in the last 60 days
- treatments with oral cavity disinfectants in the last 30 days
- presence of other pre-existing or ongoing respiratory pathologies
- current severe sepsis (sepsis criteria + organ dysfunction, peripheral hypoperfusion, hypotension)
About this study
Official title: Analisi Del Microbiota Nasofaringeo in Pazienti Con Infezioni Respiratorie
Respiratory tract infections represent the most frequent infectious pathology in community environments and when of bacterial origin, imply a morbid state generally supported by a pathogenic bacterial species predominant on the commensal flora of the airways. Among the most frequent bacterial infections of the upper respiratory tract in pediatric age we find acute bacterial pharyngitis or pharyngotonsillitis caused by Streptococcus pyogenes (β-hemolytic group A), for which antimicrobial therapy is clearly indicated, and which manifests itself with an onset sudden fever. It should also be remembered that some forms of pharyngitis are caused by Chlamydia pneumoniae, Mycoplasma pneumoniae, Bordetella pertussis and Legionella, commonly responsible for lower respiratory tract infections but recently also associated with upper respiratory tract infections. In childhood, a viral or bacterial infection of the upper respiratory tract (in particular pharyngitis, laryngitis) can easily lead to an infection of the lower respiratory tract (pneumonia). In fact, the inflammatory process triggered by a previous infection, generally viral, determines an impairment of mucociliary clearance which facilitates the proliferation not only of pathogenic bacteria but also of the commensal bacterial flora, normally non-pathogenic. An altered local microbial flora can, therefore, contribute to the pathogenesis of new infections or itself be responsible for invasive infections. The microbiota of the upper airways may therefore be a further factor influencing the susceptibility, frequency and severity of acute respiratory diseases. The oropharyngeal microbiota is in fact made up of numerous bacterial species which, by colonizing this anatomical tract, interact with the mucosa of the pharynx and therefore with the immune system, contributing to the homeostasis of the upper respiratory tract and consequently also preserving the integrity of the lower respiratory tract. As observed for other anatomical sites, the composition of the oropharyngeal microbiota is conditioned by external events, among which we find the use of antibiotics or oral disinfectant drugs which can favor the development of pathogenic microorganisms. Characterizing the oropharyngeal microbiota in a state of acute and/or chronic respiratory infection could increase knowledge on the microbiological signature associated with such infections and ineffective antibiotic treatments. Greater knowledge of it, also with future corrective purposes, as has now been demonstrated for other body areas, could be of great help in reducing the risk of acute recurrent disease and/or chronic consequences.
Read the detailed description
In recent years, the microbiota of the upper airways has emerged as a further factor influencing the susceptibility, frequency and severity of acute respiratory diseases. Greater knowledge of it, also with corrective purposes, as has now been demonstrated for other body areas, could be of great help in reducing the risk of acute recurrent disease and/or chronic consequences. The oropharyngeal microbiota is in fact made up of numerous bacterial species which, by colonizing this anatomical tract, interact with the mucosa of the pharynx and therefore with the immune system, contributing to the homeostasis of the upper respiratory tract and consequently also preserving the integrity of the lower respiratory tract. As observed for other anatomical sites, the composition of the oropharyngeal microbiota is conditioned by external events, among which we find the use of antibiotics or oral disinfectant drugs which can favor the development of pathogenic microorganisms. For this reason, characterizing the oropharyngeal microbiota in a state of acute and/or chronic respiratory infection could increase knowledge on the microbiological signature associated with such infections and ineffective antibiotic treatments to the point of becoming a factor used to prevent respiratory tract infections.
- Conditions
- Respiratory Infection
- Keywords
- microbiota faringeo, infezioni respiratorie
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| controls | Not described | |
| patients with S. pyogenes infection | Not described | |
| patients with other respiratory infections | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pharingeal microbiota
Characterization of the pharyngeal microbiome (alpha and beta diversity, relative and differential abundances) in patients with symptoms attributable to respiratory infections
Measured: 24 months
Secondary outcomes (1)
Differences in microbiota in patients with diverse respiratory infections
To compare the pharyngeal microbiome (alpha and beta diversity, relative and differential abundances) of patients with bacterial respiratory infections with that of patients suffering from respiratory infections of viral origin at the time of diagnosis (baseline).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start15 Sep 2024 (estimated)
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, De Maio Flavio, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556420
- Sponsor's protocol ID
- 6603
- Acronym
- MINIPAR
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analisi Del Microbiota Nasofaringeo in Pazienti Con Infezioni Respiratorie
- ClinicalTrials.gov ID
- NCT06556420
- Acronym / sponsor ID
- MINIPAR / 6603
- Conditions
- Respiratory Infection
- Keywords
- microbiota faringeo, infezioni respiratorie
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Respiratory tract infections represent the most frequent infectious pathology in community environments and when of bacterial origin, imply a morbid state generally supported by a pathogenic bacterial species predominant on the commensal flora of the airways. Among the most frequent bacterial infections of the upper respiratory tract in pediatric age we find acute bacterial pharyngitis or pharyngotonsillitis caused by Streptococcus pyogenes (β-hemolytic group A), for which antimicrobial therapy is clearly indicated, and which manifests itself with an onset sudden fever. It should also be remembered that some forms of pharyngitis are caused by Chlamydia pneumoniae, Mycoplasma pneumoniae, Bordetella pertussis and Legionella, commonly responsible for lower respiratory tract infections but recently also associated with upper respiratory tract infections. In childhood, a viral or bacterial infection of the upper respiratory tract (in particular pharyngitis, laryngitis) can easily lead to an infection of the lower respiratory tract (pneumonia). In fact, the inflammatory process triggered by a previous infection, generally viral, determines an impairment of mucociliary clearance which facilitates the proliferation not only of pathogenic bacteria but also of the commensal bacterial flora, normally non-pathogenic. An altered local microbial flora can, therefore, contribute to the pathogenesis of new infections or itself be responsible for invasive infections. The microbiota of the upper airways may therefore be a further factor influencing the susceptibility, frequency and severity of acute respiratory diseases. The oropharyngeal microbiota is in fact made up of numerous bacterial species which, by colonizing this anatomical tract, interact with the mucosa of the pharynx and therefore with the immune system, contributing to the homeostasis of the upper respiratory tract and consequently also preserving the integrity of the lower respiratory tract. As observed for other anatomical sites, the composition of the oropharyngeal microbiota is conditioned by external events, among which we find the use of antibiotics or oral disinfectant drugs which can favor the development of pathogenic microorganisms. Characterizing the oropharyngeal microbiota in a state of acute and/or chronic respiratory infection could increase knowledge on the microbiological signature associated with such infections and ineffective antibiotic treatments. Greater knowledge of it, also with future corrective purposes, as has now been demonstrated for other body areas, could be of great help in reducing the risk of acute recurrent disease and/or chronic consequences.
Detailed description
In recent years, the microbiota of the upper airways has emerged as a further factor influencing the susceptibility, frequency and severity of acute respiratory diseases. Greater knowledge of it, also with corrective purposes, as has now been demonstrated for other body areas, could be of great help in reducing the risk of acute recurrent disease and/or chronic consequences. The oropharyngeal microbiota is in fact made up of numerous bacterial species which, by colonizing this anatomical tract, interact with the mucosa of the pharynx and therefore with the immune system, contributing to the homeostasis of the upper respiratory tract and consequently also preserving the integrity of the lower respiratory tract. As observed for other anatomical sites, the composition of the oropharyngeal microbiota is conditioned by external events, among which we find the use of antibiotics or oral disinfectant drugs which can favor the development of pathogenic microorganisms. For this reason, characterizing the oropharyngeal microbiota in a state of acute and/or chronic respiratory infection could increase knowledge on the microbiological signature associated with such infections and ineffective antibiotic treatments to the point of becoming a factor used to prevent respiratory tract infections.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| controls | – | – |
| patients with S. pyogenes infection | – | – |
| patients with other respiratory infections | – | – |
Who may qualify
- Ages
- 0 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who access the Pediatric Emergency Department with respiratory symptoms attributable to acute respiratory infection attributable to a bacterial and/or viral nature (diagnosed through nasopharyngeal swab as per normal clinical practice), who have given their informed consent to participate in this study. Subjects accessing the Pediatric Emergency Department who will perform a nasopharyngeal swab, as per normal clinical practice, with a negative result will also be included in the study as controls, considering the same exclusion criteria reported below. Informed consent will therefore be acquired upon entry to the Pediatric Emergency Department and in relation to the outcome of the nasopharyngeal swab the subjects will then be stratified into groups.
Key inclusion criteria (2 listed)
- age 0-20 years
- signs and/or symptoms of acute respiratory tract infection such as cold, pharyngitis, laryngitis, tracheitis, otitis, epiglottitis, laryngotracheitis, bronchitis and pneumonia.
Key exclusion criteria (7 listed)
- antibiotic therapies in the last 30 days
- treatments with prebiotics or probiotics in the last 60 days (in particular containing Streptococcus salivarius)
- hormone therapies in the last 60 days
- local therapies in the last 60 days
- treatments with oral cavity disinfectants in the last 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of pharingeal microbiota
Time frame: 24 months
Characterization of the pharyngeal microbiome (alpha and beta diversity, relative and differential abundances) in patients with symptoms attributable to respiratory infections
1 secondary outcome
Differences in microbiota in patients with diverse respiratory infections
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Infection, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pharingeal microbiota (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.