PneumoniaNCT06246994
Predictors of Mortality Among Ventilator Associated Pneumonia Patients
An observational study of Pneumonia, run by Assiut University.
Trial summary
In this context, this study aims to explore the risk factors for mortality from VAP in respiratory ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Sep 2025
- 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: This study will enroll adult participants over 18 years old who had undergone mechanical ventilation for longer than 48 hours. Only the first episode of VAP for each patient will be included.
Who may be able to join
- adult participants over 18 years old who had undergone mechanical ventilation for longer than 48 hours.
- Only the first episode of VAP for each patient will be included.
Who cannot join
- Patients who are less than 18 years old.
- Pneumonia diagnosed before mechanical ventilation.
Trial locations and contacts
No sites are listed yet.
About this study
In this context, this study aims to explore the risk factors for mortality from VAP in respiratory ICU.
Read the detailed description
Pneumonia is the most common infection treated within ICUs and carries significant mortality risk . Ventilator-associated pneumonia (VAP) is a specific form of nosocomial pneumonia occurring in patients greater than 48 hours after intubation and the initiation of mechanical ventilation .
VAP is considered a leading cause of morbidity and mortality among intensive care unit infections. Despite various preventive measures, the incidence of VAP remains high .
In studies, VAP-related mortality is 14-70% . It is contemplated that there are independent risk factors, increasing VAP-related mortality .
However, the question of which factors are associated with early or late mortality in patients with VAP diagnosis, remains unanswered. Early identification and understanding of the etiology of VAP in the ICU is essential to prevent mortality and morbidity.
- Conditions
- Pneumonia
- Medical subject headings
- Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate at 28 days.
Evaluation of number of dead patients from vap wihin 28 days of infection and
Measured: 28 days
Percentage of risk factors of VAP mortality.
Search for risk factors for mortality of vap wihin 28 days of infection.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Hussien kilany, Assiut University
- Investigators
- Doaa Magdy, assisst -professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246994
- Sponsor's protocol ID
- Predictors of vap mortality
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vincent JL, Sakr Y, Singer M, Martin-Loeches I, Machado FR, Marshall JC, Finfer S, Pelosi P, Brazzi L, Aditianingsih D, Timsit JF, Du B, Wittebole X, Maca J, Kannan S, Gorordo-Delsol LA, De Waele JJ, Mehta Y, Bonten MJM, Khanna AK, Kollef M, Human M, Angus DC; EPIC III Investigators. Prevalence and Outcomes of Infection Among Patients in Intensive Care Units in 2017. JAMA. 2020 Apr 21;323(15):1478-1487. doi: 10.1001/jama.2020.2717.
PubMed 32207816Zhou XY, Ben SQ, Chen HL, Ni SS. A comparison of APACHE II and CPIS scores for the prediction of 30-day mortality in patients with ventilator-associated pneumonia. Int J Infect Dis. 2015 Jan;30:144-7. doi: 10.1016/j.ijid.2014.11.005. Epub 2014 Nov 12.
PubMed 25461659Arayasukawat P, So-Ngern A, Reechaipichitkul W, Chumpangern W, Arunsurat I, Ratanawatkul P, Chuennok W. Microorganisms and clinical outcomes of early- and late-onset ventilator-associated pneumonia at Srinagarind Hospital, a tertiary center in Northeastern Thailand. BMC Pulm Med. 2021 Jan 30;21(1):47. doi: 10.1186/s12890-021-01415-8.
PubMed 33516213John AO, Paul H, Vijayakumar S, Anandan S, Sudarsan T, Abraham OC, Balaji V. Mortality from acinetobacter infections as compared to other infections among critically ill patients in South India: A prospective cohort study. Indian J Med Microbiol. 2020 Jan-Mar;38(1):24-31. doi: 10.4103/ijmm.IJMM_19_492.
PubMed 32719205Zimmerman JE, Kramer AA, McNair DS, Malila FM, Shaffer VL. Intensive care unit length of stay: Benchmarking based on Acute Physiology and Chronic Health Evaluation (APACHE) IV. Crit Care Med. 2006 Oct;34(10):2517-29. doi: 10.1097/01.CCM.0000240233.01711.D9.
PubMed 16932234
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Mortality Among Ventilator Associated Pneumonia Patients
- ClinicalTrials.gov ID
- NCT06246994
- Acronym / sponsor ID
- Predictors of vap mortality
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 7 Feb 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.
In this context, this study aims to explore the risk factors for mortality from VAP in respiratory ICU.
Detailed description
Pneumonia is the most common infection treated within ICUs and carries significant mortality risk . Ventilator-associated pneumonia (VAP) is a specific form of nosocomial pneumonia occurring in patients greater than 48 hours after intubation and the initiation of mechanical ventilation .
VAP is considered a leading cause of morbidity and mortality among intensive care unit infections. Despite various preventive measures, the incidence of VAP remains high .
In studies, VAP-related mortality is 14-70% . It is contemplated that there are independent risk factors, increasing VAP-related mortality .
However, the question of which factors are associated with early or late mortality in patients with VAP diagnosis, remains unanswered. Early identification and understanding of the etiology of VAP in the ICU is essential to prevent mortality and morbidity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll adult participants over 18 years old who had undergone mechanical ventilation for longer than 48 hours. Only the first episode of VAP for each patient will be included.
Key inclusion criteria (2 listed)
- adult participants over 18 years old who had undergone mechanical ventilation for longer than 48 hours.
- Only the first episode of VAP for each patient will be included.
Key exclusion criteria (2 listed)
- Patients who are less than 18 years old.
- Pneumonia diagnosed before mechanical ventilation.
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
Mortality rate at 28 days.
Time frame: 28 days
Evaluation of number of dead patients from vap wihin 28 days of infection and
Percentage of risk factors of VAP mortality.
Time frame: 28 days
Search for risk factors for mortality of vap wihin 28 days of infection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Results publication: PubMed 32207816Vincent JL, Sakr Y, Singer M, Martin-Loeches I, Machado FR, Marshall JC, Finfer S, Pelosi P, Brazzi L, Aditianingsih D, Timsit JF, Du B, Wittebole X, Maca J, Kannan S, Gorordo-Delsol LA, De Waele JJ, Mehta Y, Bonten MJM, Khanna AK, Kollef M, Human M, Angus DC; EPIC III Investigators. Prevalence and Outcomes of Infection Among Patients in Intensive Care Units in 2017. JAMA. 2020 Apr 21;323(15):1478-1487. doi: 10.1001/jama.2020.2717.
- Results publication: PubMed 25461659Zhou XY, Ben SQ, Chen HL, Ni SS. A comparison of APACHE II and CPIS scores for the prediction of 30-day mortality in patients with ventilator-associated pneumonia. Int J Infect Dis. 2015 Jan;30:144-7. doi: 10.1016/j.ijid.2014.11.005. Epub 2014 Nov 12.
- Results publication: PubMed 33516213Arayasukawat P, So-Ngern A, Reechaipichitkul W, Chumpangern W, Arunsurat I, Ratanawatkul P, Chuennok W. Microorganisms and clinical outcomes of early- and late-onset ventilator-associated pneumonia at Srinagarind Hospital, a tertiary center in Northeastern Thailand. BMC Pulm Med. 2021 Jan 30;21(1):47. doi: 10.1186/s12890-021-01415-8.
- Results publication: PubMed 32719205John AO, Paul H, Vijayakumar S, Anandan S, Sudarsan T, Abraham OC, Balaji V. Mortality from acinetobacter infections as compared to other infections among critically ill patients in South India: A prospective cohort study. Indian J Med Microbiol. 2020 Jan-Mar;38(1):24-31. doi: 10.4103/ijmm.IJMM_19_492.
- Results publication: PubMed 16932234Zimmerman JE, Kramer AA, McNair DS, Malila FM, Shaffer VL. Intensive care unit length of stay: Benchmarking based on Acute Physiology and Chronic Health Evaluation (APACHE) IV. Crit Care Med. 2006 Oct;34(10):2517-29. doi: 10.1097/01.CCM.0000240233.01711.D9.
- 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.
Doaa Magdy, assisst -professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of 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 13 Feb 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?
Contact Marwa Kilany, Assisst- lecture (01064123545, docmero1693@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate at 28 days. (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06246994, which also lists 5 linked publications.
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 13 Feb 2024.