VAP - Ventilator Associated PneumoniaVAPNCT05738928
Microbiological Profile of VAP Patients in Respiratory ICU
An observational study of VAP - Ventilator Associated Pneumonia, run by Assiut University.
Trial summary
Identification of the microbial profile of Ventilator associated pneumonia causing microorganisms among Respiratory ICU patients . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VAP - Ventilator Associated Pneumonia
- What is being tested?
- blood and sputum culture
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Feb 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age more than 18 years. Mechanically ventilated patient who developed pneumonia after48 hours after endotracheal intubation.
Who may be able to join
- Mechanically ventilated patient who developed pneumonia after48 hours after endotracheal intubation.
- Age > 18 years.
Who cannot join
- Patients with clinical and radiological signs suggestive of pneumonia before intubation (community acquired pneumonia or hospital acquired pneumonia)
- Patients age ≤18 years old
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Microbiological Profile of Ventilator Associated Pneumonia in Respiratory Intensive Care Unit of Assiut University Hospital
Identification of the microbial profile of Ventilator associated pneumonia causing microorganisms among Respiratory ICU patients .
Read the detailed description
Ventilator-associated pneumonia (VAP) is one of the common serious infectious diseases encountered in the intensive care unit (ICU), which highly affects the healthcare cost and patient prognosis.
All-cause of mortality associated with VAP has been reported to range from 20% to 50%.
The etiology of VAP and their antimicrobial susceptibility pattern varies with different patient populations and types of ICUs.
VAP may be caused by a wide spectrum of bacterial pathogens, which may be polymicrobial and are rarely due to viral or fungal pathogens in immune-competent hosts.
Common etiologic agents are Gram-negative bacilli such as Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, and Acinetobacter spp. and Staphylococcus aureus among Gram-positive cocci.
Due to the increased incidence of MDR organisms in Intensive Care Units (ICUs), early and correct diagnosis of VAP is mandatory for optimal antibiotic therapy. The frequency of specific MDR pathogens causing VAP varies in hospitals, patient populations. Also varies according underlying disease.
this study will be conducted in respiratory intensive care unit, chest disease and tuberculosis department at Assiut university hospitals.
- Conditions
- VAP - Ventilator Associated Pneumonia
- Being tested
- blood and sputum culture
- 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.
blood and sputum cultureDiagnostic test
Noninvasive sampling ( Endo Tracheal Aspiration) for staining and culture. Blood culture .
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological profile of ventilator associated pneumonia in Respiratory ICU in Assiut University Hospital.
Identify the microbial profile of VAP causing microorganisms among ICU patients, antimicrobial susceptibility patterns among the frequently isolated organisms and resistant strains.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VAP - Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Abdelhameed Hassan Ali, Assiut University
- Investigators
- mohammed M Abdelhadi, PhD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738928
- Sponsor's protocol ID
- Microbiological profile of VAP
- Acronym
- VAP
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Profile of Ventilator Associated Pneumonia in Respiratory Intensive Care Unit of Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05738928
- Acronym / sponsor ID
- VAP / Microbiological profile of VAP
- Conditions
- VAP - Ventilator Associated Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 22 Feb 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.
Identification of the microbial profile of Ventilator associated pneumonia causing microorganisms among Respiratory ICU patients .
Detailed description
Ventilator-associated pneumonia (VAP) is one of the common serious infectious diseases encountered in the intensive care unit (ICU), which highly affects the healthcare cost and patient prognosis.
All-cause of mortality associated with VAP has been reported to range from 20% to 50%.
The etiology of VAP and their antimicrobial susceptibility pattern varies with different patient populations and types of ICUs.
VAP may be caused by a wide spectrum of bacterial pathogens, which may be polymicrobial and are rarely due to viral or fungal pathogens in immune-competent hosts.
Common etiologic agents are Gram-negative bacilli such as Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, and Acinetobacter spp. and Staphylococcus aureus among Gram-positive cocci.
Due to the increased incidence of MDR organisms in Intensive Care Units (ICUs), early and correct diagnosis of VAP is mandatory for optimal antibiotic therapy. The frequency of specific MDR pathogens causing VAP varies in hospitals, patient populations. Also varies according underlying disease.
this study will be conducted in respiratory intensive care unit, chest disease and tuberculosis department at Assiut university hospitals.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age more than 18 years. Mechanically ventilated patient who developed pneumonia after48 hours after endotracheal intubation.
Key inclusion criteria (2 listed)
- Mechanically ventilated patient who developed pneumonia after48 hours after endotracheal intubation.
- Age > 18 years.
Key exclusion criteria (2 listed)
- Patients with clinical and radiological signs suggestive of pneumonia before intubation (community acquired pneumonia or hospital acquired pneumonia)
- Patients age ≤18 years old
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 |
|---|---|---|
| blood and sputum cultureNoninvasive sampling ( Endo Tracheal Aspiration) for staining and culture. Blood culture . | Diagnostic test | – |
Primary outcome
Microbiological profile of ventilator associated pneumonia in Respiratory ICU in Assiut University Hospital.
Time frame: 1 year
Identify the microbial profile of VAP causing microorganisms among ICU patients, antimicrobial susceptibility patterns among the frequently isolated organisms and resistant strains.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
mohammed M Abdelhadi, PhD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of VAP - Ventilator Associated Pneumonia, run by Assiut University.
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 2 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 22 Feb 2023. 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?
Contact Manar A Hassan, bacheoler (+201152808012, manarabdelhameed89@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological profile of ventilator associated pneumonia in Respiratory ICU in Assiut University Hospital. (time frame: 1 year). 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 22 Feb 2023.