Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04325685
Other study ID # SGDC-VAP-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date November 7, 2023

Study information

Verified date November 2023
Source Northern State Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Oropharynx is the main source of pathogen microorganisms for the ventilator - associated pneumoniae. As known bacteriophages can eliminate different pathogen microorganisms or reduce a degree of a pathogen's colonization. The research team is considering that oropharyngeal decontamination with bacteriophages can prevent the developing of the ventilator - associated pneumoniae. There will be three groups in this investigation: placebo, antiseptic drug (Octenisept) and bacteriophage (Sexthaphag).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 7, 2023
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - invasive mechanical ventilation beyond 48 hours Exclusion Criteria: - hospital - acquired pneumonia - community - acquired pneumoniae - BMI > 35 kg/cm2 - pregnancy - tracheostomy - reintubation

Study Design


Intervention

Drug:
Control
Oropharyngeal decontamination with saline will be performing three time a day every 8 hours during mechanical ventilation
Antiseptic Solution
Oropharyngeal decontamination with antiseptic solution will be performing three time a day every 8 hours during mechanical ventilation
Bacteriophage
Oropharyngeal decontamination with bacteriophage will be performing three time a day every 8 hours during mechanical ventilation

Locations

Country Name City State
Russian Federation Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2" Severodvinsk Arkhangelsk Region

Sponsors (1)

Lead Sponsor Collaborator
Northern State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of ventilator-associated pneumonia (VAP) CPIS is using for diagnosis the VAP, if CPIS equal or more 6, the VAP will be confirmed Change from Baseline CPIS at 14 days
Primary Changing of oral and lung microbiomes Microbiology researching samples from oral cavity and trachea. The Gram positive and Gram negative aerobes and anaerobes will be assessed with observing Colony Form Unit Change from Baseline Microbiology researching at 14 days
Secondary Organ dysfunction Sequential Organ Function Assessment (SOFA) will be using for assessment organ dysfunction Patient examination with Sequential Organ Function Assessment (SOFA). If Sequential Organ Function Assessment more then 2 points Organ dysfunction is present. The hirher value is equal worse outcome Change from Baseline Sequential Organ Function Assessment at 14 days
Secondary Concentration of C - reactive protein (CRP) Biomarker of the VAP Change from Baseline CRP at 14 days
Secondary Concentration of Procalcitonin (PCT) Biomarker of the VAP Change from Baseline PCT at 14 days
Secondary Rate of Mortality Mortality for 28 days of a hospitalization Change from Baseline PCT at 28 days
See also
  Status Clinical Trial Phase
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Recruiting NCT05535543 - Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
Completed NCT04695392 - Restore Resilience in Critically Ill Children N/A
Terminated NCT04972318 - Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia N/A
Completed NCT04534569 - Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)
Completed NCT04078984 - Driving Pressure as a Predictor of Mechanical Ventilation Weaning Time on Post-ARDS Patients in Pressure Support Ventilation.
Completed NCT04451291 - Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure N/A
Not yet recruiting NCT06254313 - The Role of Cxcr4Hi neutrOPhils in InflueNza
Not yet recruiting NCT04798716 - The Use of Exosomes for the Treatment of Acute Respiratory Distress Syndrome or Novel Coronavirus Pneumonia Caused by COVID-19 Phase 1/Phase 2
Withdrawn NCT04909879 - Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome Phase 2
Not yet recruiting NCT02881385 - Effects on Respiratory Patterns and Patient-ventilator Synchrony Using Pressure Support Ventilation N/A
Terminated NCT02867228 - Noninvasive Estimation of Work of Breathing N/A
Completed NCT02545621 - A Role for RAGE/TXNIP/Inflammasome Axis in Alveolar Macrophage Activation During ARDS (RIAMA): a Proof-of-concept Clinical Study
Completed NCT02232841 - Electrical Impedance Imaging of Patients on Mechanical Ventilation N/A
Withdrawn NCT02253667 - Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients N/A
Completed NCT02889770 - Dead Space Monitoring With Volumetric Capnography in ARDS Patients N/A
Completed NCT01504893 - Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic Anesthesia N/A
Withdrawn NCT01927237 - Pulmonary Vascular Effects of Respiratory Rate & Carbon Dioxide N/A
Completed NCT01680783 - Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure N/A
Completed NCT02814994 - Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients N/A