Ventilator Associated PneumoniaPhase 2/3NCT05895773
Oro-nasal Decontamination to Prevent Ventilator-associated Pneumonia
A Phase 2/3 study testing Povidone-Iodine and Saline spray in people with Ventilator Associated Pneumonia, run by Menoufia University at 1 site in Egypt.
Trial summary
It has been shown that oral hygiene reduces the incidence of ventilator-associated pneumonia (VAP). The nasopharynx is considered to be an important source of contaminated micro aspiration to the lung however, the effect of nasopharyngeal decontamination on VAP has not been yet investigated. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Povidone-Iodine and Saline spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jun 2023to 24 Nov 2023
- Phase
- Phase 2/3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- on mechanical ventilation less than 24 h after admission and expected to continue mechanical ventilation for more than 72h.
Who cannot join
- Exclusion criteria include immunosuppression, aspiration pneumonia, all types of pneumonia, sepsis and septic shock, tracheostomy, and pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nasal and Oropharyngeal Use of Povidone Iodine and Glycyrrhizin on Ventilator-associated Respiratory Infections: A Randomized Trial
It has been shown that oral hygiene reduces the incidence of ventilator-associated pneumonia (VAP). The nasopharynx is considered to be an important source of contaminated micro aspiration to the lung however, the effect of nasopharyngeal decontamination on VAP has not been yet investigated. The investigators hypothesized that decontamination of oral and nasopharyngeal cavities with combined Povidone Iodine and glycyrrhizin would remarkably reduce the incidence of VAP.
Read the detailed description
Infections that occur more than 48 hours after intubation are known as ventilator-associated pneumonia (VAP) and ventilator-associated tracheobronchitis (VAT). The incidence of VAP in mechanically ventilated patients ranges from 8 to 48% with a mortality rate of 24%-76%.
These infections are a serious problem that Increases the need for prolonged hospitalization, antimicrobial therapy, and rising healthcare expenses. As a result, preventing VAP and VAT is critical to improving the quality of life by reducing complications in mechanically ventilated patients.
Intubation is a mechanical procedure that Breaks the natural barrier, allowing bacteria to colonize. Microorganisms enter the lungs through the lower respiratory tract from the oropharynx, the endotracheal tube cuff leaks, or the biofilm in the endotracheal tube. The microbial flora in the oral cavities of hospitalized patients, particularly those mechanically ventilated, gradually changes; gram-positive bacteria of low virulence predominate at admission (Streptococcus spp., Actinomyces spp.) are gradually replaced by more virulent gram-negative, potentially pathogenic microbial flora. This change happens on mucosal surfaces as well as in dental plaque, which in the physiological state are populated by 200-350 different bacterial species. The nasal-oropharyngeal axis involves nasal secretions swept to the oropharynx by mucociliary clearance followed by the aspiration of infected fluid into the lower airway. Nasal-oropharyngeal axis with subsequent seeding of the lungs leads to respiratory disease. The investigators hypothesized that micro aspirates from the nasopharynx and oropharynx are substantially contributing to the development of both VAT and VAP and the decontamination of the nasal and oral cavity would greatly help in the reduction of VAP and VAT. The purpose of this study is to compare the effect of nasal and Oro-pharyngeal use of a combination of Povidone Iodine (PVI) and Glycyrrhizin (GA) [treatment group] for oral and nasal decontamination on preventing VAP and VAT with the placebo group. Another objective is to compare the effect of treatment used for oral care on oral health and the prevention of microbial colonization in the mouth with the placebo group.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Povidone-Iodine, Saline spray
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-IodineDrug
Also called glycyrrhizic acid
Povidone Iodine 0.5% plus glycyrrhizin acid 2.5 mg/ml as a nasal and an oropharyngeal spray (mint flavored) will be applied 4 times per day.
Saline sprayDrug
Also called Normal saline
Normal saline 0.9% as a nasal and oropharyngeal spray (Mint flavored) will be applied 4 times per day.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Nasal and oropharyngeal Povidone Iodine plus Glycyrrhizin sprays will be applied 4 times daily after tooth cleaning with a brush. Receives: Drug: Povidone-Iodine |
| Placebo group | Placebo comparator | Nasal and oropharyngeal saline sprays will be applied 4 times daily after teeth cleaning with a brush. Receives: Drug: Saline spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilator-associated pneumonia.
Clinical criteria for VAP include the following: worsened or development of new infiltrates in chest radiographs, body temperature less than 35°C or more than 38.5 °C, the leukocytic count below 4000 /mm3 or more than 11000/ mm3, tracheal aspirate of sputum or purulent discharge, and the demand for a positive end-expiratory pressure by more than 20% to keep oxygen saturation above 92% or the need for an increase in the inspired oxygen fraction. Each parameter is given a score of 0, 1, or 2. A score of 6 or more confirms VAP.
Measured: every day for 15 days
Secondary outcomes (4)
Beck oral assessment score.
Examination of lips, gingiva, oral mucosa, tongue, teeth, and saliva each given 1 to 4 according to severity. a total score of 5 denotes no dysfunction while a score from 16 to 20 indicates severe dysfunction.
Measured: 4,8 and 12 hours after oral hygiene.
Mechanical ventilation length.
Days spent by the patient on the ventilator.
Measured: up to 24 weeks.
Mortality
Percentage of patients died from VAP.
Measured: up to 6 months.
Length of ICU stay.
Number of days patients need to be discharged from ICU.
Measured: up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start24 Jun 2023
- Primary completion24 Nov 2023
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomly allocated using a computer program into two equal groups: the treatment group and the placebo group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazem Ezzat Elsersy, Menoufia University
- Investigators
- Hazem E Elsersy, MD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895773
- Sponsor's protocol ID
- 4/2023ANET2
- Status last verified
- Nov 2023
- First submitted
- 18 May 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nasal and Oropharyngeal Use of Povidone Iodine and Glycyrrhizin on Ventilator-associated Respiratory Infections: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05895773
- Acronym / sponsor ID
- 4/2023ANET2
- Conditions
- Ventilator Associated Pneumonia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 24 Jun 2023 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 9 Jun 2023 (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.
It has been shown that oral hygiene reduces the incidence of ventilator-associated pneumonia (VAP). The nasopharynx is considered to be an important source of contaminated micro aspiration to the lung however, the effect of nasopharyngeal decontamination on VAP has not been yet investigated. The investigators hypothesized that decontamination of oral and nasopharyngeal cavities with combined Povidone Iodine and glycyrrhizin would remarkably reduce the incidence of VAP.
Detailed description
Infections that occur more than 48 hours after intubation are known as ventilator-associated pneumonia (VAP) and ventilator-associated tracheobronchitis (VAT). The incidence of VAP in mechanically ventilated patients ranges from 8 to 48% with a mortality rate of 24%-76%.
These infections are a serious problem that Increases the need for prolonged hospitalization, antimicrobial therapy, and rising healthcare expenses. As a result, preventing VAP and VAT is critical to improving the quality of life by reducing complications in mechanically ventilated patients.
Intubation is a mechanical procedure that Breaks the natural barrier, allowing bacteria to colonize. Microorganisms enter the lungs through the lower respiratory tract from the oropharynx, the endotracheal tube cuff leaks, or the biofilm in the endotracheal tube. The microbial flora in the oral cavities of hospitalized patients, particularly those mechanically ventilated, gradually changes; gram-positive bacteria of low virulence predominate at admission (Streptococcus spp., Actinomyces spp.) are gradually replaced by more virulent gram-negative, potentially pathogenic microbial flora. This change happens on mucosal surfaces as well as in dental plaque, which in the physiological state are populated by 200-350 different bacterial species. The nasal-oropharyngeal axis involves nasal secretions swept to the oropharynx by mucociliary clearance followed by the aspiration of infected fluid into the lower airway. Nasal-oropharyngeal axis with subsequent seeding of the lungs leads to respiratory disease. The investigators hypothesized that micro aspirates from the nasopharynx and oropharynx are substantially contributing to the development of both VAT and VAP and the decontamination of the nasal and oral cavity would greatly help in the reduction of VAP and VAT. The purpose of this study is to compare the effect of nasal and Oro-pharyngeal use of a combination of Povidone Iodine (PVI) and Glycyrrhizin (GA) [treatment group] for oral and nasal decontamination on preventing VAP and VAT with the placebo group. Another objective is to compare the effect of treatment used for oral care on oral health and the prevention of microbial colonization in the mouth with the placebo group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients will be randomly allocated using a computer program into two equal groups: the treatment group and the placebo group.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Povidone-IodineNasal and oropharyngeal Povidone Iodine plus Glycyrrhizin sprays will be applied 4 times daily after tooth cleaning with a brush. |
| Placebo group | Placebo comparator | Drug: Saline sprayNasal and oropharyngeal saline sprays will be applied 4 times daily after teeth cleaning with a brush. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- on mechanical ventilation less than 24 h after admission and expected to continue mechanical ventilation for more than 72h.
Key exclusion criteria (1 listed)
- Exclusion criteria include immunosuppression, aspiration pneumonia, all types of pneumonia, sepsis and septic shock, tracheostomy, and pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Povidone-IodineAlso: glycyrrhizic acidPovidone Iodine 0.5% plus glycyrrhizin acid 2.5 mg/ml as a nasal and an oropharyngeal spray (mint flavored) will be applied 4 times per day. | Drug | Treatment group |
| Saline sprayAlso: Normal salineNormal saline 0.9% as a nasal and oropharyngeal spray (Mint flavored) will be applied 4 times per day. | Drug | Placebo group |
Primary outcome
ventilator-associated pneumonia.
Time frame: every day for 15 days
Clinical criteria for VAP include the following: worsened or development of new infiltrates in chest radiographs, body temperature less than 35°C or more than 38.5 °C, the leukocytic count below 4000 /mm3 or more than 11000/ mm3, tracheal aspirate of sputum or purulent discharge, and the demand for a positive end-expiratory pressure by more than 20% to keep oxygen saturation above 92% or the need for an increase in the inspired oxygen fraction. Each parameter is given a score of 0, 1, or 2. A score of 6 or more confirms VAP.
4 secondary outcomes
Beck oral assessment score.
Time frame: 4,8 and 12 hours after oral hygiene.
Mechanical ventilation length.
Time frame: up to 24 weeks.
Mortality
Time frame: up to 6 months.
Length of ICU stay.
Time frame: up to 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Related trials for Ventilator Associated Pneumonia
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Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
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Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
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.
Hazem E Elsersy, MD principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Povidone-Iodine and Saline spray in people with Ventilator Associated Pneumonia, run by Menoufia University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ventilator-associated pneumonia. (time frame: every day for 15 days). 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 27 Nov 2023.