Ventilator Associated PneumoniaNCT04563104
Lung Ultrasound in Procalcitonin- Guided Antibiotic Discontinuation in Ventilator Associated Pneumonia
An observational study of Ventilator Associated Pneumonia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Ventilator Associated pneumonia (VAP) is associated with longer ICU length of stay, prolonged mechanical ventilation, and increased use of antimicrobials, health-care cost and mortality . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Lung Ultrasound
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Sep 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients having ventilator associated pneumonia (VAP) with positive sputum culture. VAP was considered if the onset occurred following intubation of the trachea for 48 h and the infection was absent before starting mechanical ventilation . Diagnosis of pneumonia was based on radiographic finding of pulmonary infiltrate; findings should be new and progressive and at least should satisfy two clinical criteria of the following: body temperature >38°C or <35.5°C; leukocyte count > 12,000 cells/mm3 or <4000 cells/mm3; and clinical evidence of pneumonia, such as purulent secretions and a decrease in oxygenation. Diagnosis of VAP was confirmed microbiologically by positive bronchial secretion cultures
Who may be able to join
- 18 years old or greater
- Ventilator associated pneumonia (VAP) with positive sputum culture.
Who cannot join
- pregnancy,
- use of immunosuppressive agents except for steroids,
- neutropenia (white blood cell count ≤1000/mL)
- patients whose primary diagnosis was community acquired pneumonia and other source of infection.
Trial locations and contacts
1 site in 1 country.
About this study
Ventilator Associated pneumonia (VAP) is associated with longer ICU length of stay, prolonged mechanical ventilation, and increased use of antimicrobials, health-care cost and mortality . Acute respiratory infections (ARIs) comprise a large and heterogeneous group of infections, including bacterial infections, viral infections, and infections of other etiologies. Early initiation of adequate antibiotic therapy is the cornerstone in the treatment. However, overuse of antibiotics and prolonged duration of antibiotic therapy in patients with bacterial ARIs in the hospital and intensive care setting is associated with increased resistance for common bacteria, high costs, and adverse drug reactions.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Lung Ultrasound
- 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.
Lung UltrasoundDiagnostic test
We will evaluate the role of lung ultrasound on the duration of antibiotics, we hypothesize that ultrasound imaging may have a role, will be correlated with, procalcitonin (PCT). The created database will help in establishing conclusion and recommendations that will help to improve the antibiotics duration and decrease the resistance.
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between lung ultrasound and procalcitonin.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Oct 2020
- Primary completion1 Aug 2021
- Study completion1 Sep 2021
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 Ain Shams 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Ammar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563104
- Sponsor's protocol ID
- R 49 / 2020
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound in Procalcitonin- Guided Antibiotic Discontinuation in Ventilator Associated Pneumonia
- ClinicalTrials.gov ID
- NCT04563104
- Acronym / sponsor ID
- R 49 / 2020
- Conditions
- Ventilator Associated Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 24 Sep 2020 (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.
Ventilator Associated pneumonia (VAP) is associated with longer ICU length of stay, prolonged mechanical ventilation, and increased use of antimicrobials, health-care cost and mortality . Acute respiratory infections (ARIs) comprise a large and heterogeneous group of infections, including bacterial infections, viral infections, and infections of other etiologies. Early initiation of adequate antibiotic therapy is the cornerstone in the treatment. However, overuse of antibiotics and prolonged duration of antibiotic therapy in patients with bacterial ARIs in the hospital and intensive care setting is associated with increased resistance for common bacteria, high costs, and adverse drug reactions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients having ventilator associated pneumonia (VAP) with positive sputum culture. VAP was considered if the onset occurred following intubation of the trachea for 48 h and the infection was absent before starting mechanical ventilation . Diagnosis of pneumonia was based on radiographic finding of pulmonary infiltrate; findings should be new and progressive and at least should satisfy two clinical criteria of the following: body temperature >38°C or <35.5°C; leukocyte count > 12,000 cells/mm3 or <4000 cells/mm3; and clinical evidence of pneumonia, such as purulent secretions and a decrease in oxygenation. Diagnosis of VAP was confirmed microbiologically by positive bronchial secretion cultures
Key inclusion criteria (2 listed)
- 18 years old or greater
- Ventilator associated pneumonia (VAP) with positive sputum culture.
Key exclusion criteria (4 listed)
- pregnancy,
- use of immunosuppressive agents except for steroids,
- neutropenia (white blood cell count ≤1000/mL)
- patients whose primary diagnosis was community acquired pneumonia and other source of infection.
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 |
|---|---|---|
| Lung UltrasoundWe will evaluate the role of lung ultrasound on the duration of antibiotics, we hypothesize that ultrasound imaging may have a role, will be correlated with, procalcitonin (PCT). The created database will help in establishing conclusion and recommendations that will help to improve the antibiotics duration and decrease the resistance. | Diagnostic test | – |
Primary outcome
correlation between lung ultrasound and procalcitonin.
Time frame: 7 days
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 28 Sep 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia, run by Ain Shams 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 2 inclusion and 4 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 28 Sep 2021. 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. 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?
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?
correlation between lung ultrasound and procalcitonin. (time frame: 7 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 28 Sep 2021.