VAP - Ventilator Associated PneumoniaPhase 4NCT05230472
Effect of Statin Therapy on Mortality in Patients With Ventilator Associated Pneumonia
A Phase 4 study testing Simvastatin in people with VAP - Ventilator Associated Pneumonia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Statins with their powerful anti-inflammatory, immunomodulatory, and antioxidant properties make them candidate members to be used in the management of sepsis and different types of infections including pneumonia. Read more about this study
- Who is it for?
- Ages 29 to 71 years
- Conditions the study is for
- VAP - Ventilator Associated Pneumonia
- What is being tested?
- Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Feb 2022
- Phase
- Phase 4
- 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 29 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who suspected to had VAP defined as a modified Clinical Pulmonary Infection Score (CPIS) of at least 5 and if they underwent quantitative bacteriological cultures of bronchoalveolar lavage (BAL) fluid, a protected telescopic catheter (PTC), or an endotracheal aspirate. The modified CPIS is based on body temperature, blood leukocyte count, amount and appearance of tracheal secretions, ratio of partial pressure of oxygen (PaO2) to fraction of inspired oxygen, acute respiratory distress syndrome (ARDS), and infiltrates on chest radiography. The total can range from 1 to 10 points (Luna et al., 2003).
- Patients were included only for the first episode of suspected VAP.
Who cannot join
- o Statin therapy at intubation
- Previous VAP episode during the same hospitalization
- Known pregnancy
- Immunodepression with bone marrow aplasia
- Imminent death (Simplified Acute Physiology Score II of 75 or greater, calculated over the last 6 hours)
- Treatment limitation decisions
Show all 13Show fewer
- Nothing-by-mouth order and no nasogastric tube, continuous gastric aspiration
- Known chronic intestinal malabsorption
- Known simvastatin hypersensitivity
- Acute hepatic failure
- Use of CYP3A4 inhibitors or cyclosporine
- Creatine kinase level greater than 5 times the upper limit of normal
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels greater than 3 times the upper limit of normal
Trial locations and contacts
1 site in 1 country.
About this study
Statins with their powerful anti-inflammatory, immunomodulatory, and antioxidant properties make them candidate members to be used in the management of sepsis and different types of infections including pneumonia.
This study aims to determine whether adjunctive statin therapy decreased day- 28 mortality among ICU patients with ventilator-associated pneumonia (VAP) \& number of ventilator-free days (after successful weaning) between day 1 and both day 28.
Read the detailed description
This prospective randomized control-controlled triple blind study was conducted on above 18 years who had received mechanical ventilation in the ICU for at least 2 days.
All included cases were subjected to:
- Demographic data,
- Physiological variables
- Simplified Acute Physiology Score II at admission and radiologic score (Weinberg et al., 1984).
- Antibiotics used, and relevant diagnostic and therapeutic interventions in the ICU.
- The Sequential Organ Failure Assessment (SOFA) score and Clinical Pulmonary Infection Score (CPIS) were calculated on the day of enrolment (day 1) and then on days 3, 7, and 14. Patients were monitored daily for evidence of infection.
- The duration of mechanical ventilation, length of ICU stay, and length of hospital stay were recorded.
- The occurrence of myocardial ischemia or infarction was assessed until day 28. Serum levels of creatine kinase, ALT, and AST were measured.
Patients were randomly allocated to simvastatin (60 mg) or control given via a nasogastric tube or orally from study inclusion to ICU discharge, death, or day 28, whichever occurred first. Simvastatin or control were started on the same day as antibiotic therapy for suspected VAP. The simvastatin dosage was halved in patients with renal failure (creatinine clearance <30 mL/min). A computer-generated random- number table was prepared by statisticians to assign patients in blocks of 4 to receive either simvastatin or control.
Block size was unknown to the investigators, who was enrolled the patients and then called the statistics department to obtain the randomization and treatment numbers after checking the inclusion and non-inclusion criteria Outcome The primary outcome was the day-28 mortality rate. Secondary outcomes were ICU mortality rates; number of days outside the ICU between day 1 and day 28; and number of ventilator-free days (after successful weaning) between day 1 and both day 28.
Successful weaning was defined as spontaneous breathing for at least 48 hours after disconnection of the ventilator.
- Conditions
- VAP - Ventilator Associated Pneumonia
- Being tested
- Simvastatin
- 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.
SimvastatinDrug
simvastatin 60 mg tab
| Study group | Role | What they receive |
|---|---|---|
| simvastatin group | Active comparator | 68 patients who had a ventilator associated pneumonia received simvastatin Receives: Drug: Simvastatin |
| control group | No intervention | 68 patients who had a ventilator associated pneumonia not received simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was the day-28 mortality rate.
asses effect of statin on mortality in ventilator associated pneumonia patient
Measured: 28 day
Secondary outcomes (3)
ICU mortality rates
rate of mortality of patients with ventilator associated pneumonia between simvastatin group and control group in intensive care unit
Measured: between day 1 and day 28
number of days outside the ICU between day 1 and day 28
the number of days patients who have improved spent outside the icu between day 1 and day 28
Measured: between day 1 and day 28
number of ventilator-free days (after successful weaning) between day 1 and both day 28.
number of days patient of the two group spent without ventilator in the intensive care unit between day 1 and day 28 after successful weaning. Successful weaning was defined as spontaneous breathing for at least 48 hours after disconnection of the ventilator.
Measured: between day 1 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Jan 2021
- Primary completion20 Dec 2021
- Study completion1 Feb 2022
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 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly allocated to simvastatin (60 mg) or control given via a nasogastric tube or orally from study inclusion to ICU discharge, death, or day 28, whichever occurred first. Simvastatin or control were started on the same day as antibiotic therapy for suspected VAP. The simvastatin dosage was halved in patients with renal failure (creatinine clearance \<30 mL/min). A computer-generated random- number table was prepared by statisticians to assign patients in blocks of 4 to receive either simvastatin or control. Block size was unknown to the investigators, who was enrolled the patients and then called the statistics department to obtain the randomization and treatment numbers after checking the inclusion and non-inclusion criteria.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Mahmoud Farag Awad, Ain Shams University
- Investigators
- YOUSEF FAWZY, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230472
- Sponsor's protocol ID
- EMASU M D 219 /2020
- Status last verified
- Feb 2022
- First submitted
- 21 Jan 2022
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Statin Therapy on Mortality in Patients With Ventilator Associated Pneumonia
- ClinicalTrials.gov ID
- NCT05230472
- Acronym / sponsor ID
- EMASU M D 219 /2020
- Conditions
- VAP - Ventilator Associated Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 9 Feb 2022 (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.
Statins with their powerful anti-inflammatory, immunomodulatory, and antioxidant properties make them candidate members to be used in the management of sepsis and different types of infections including pneumonia.
This study aims to determine whether adjunctive statin therapy decreased day- 28 mortality among ICU patients with ventilator-associated pneumonia (VAP) \& number of ventilator-free days (after successful weaning) between day 1 and both day 28.
Detailed description
This prospective randomized control-controlled triple blind study was conducted on above 18 years who had received mechanical ventilation in the ICU for at least 2 days.
All included cases were subjected to:
- Demographic data,
- Physiological variables
- Simplified Acute Physiology Score II at admission and radiologic score (Weinberg et al., 1984).
- Antibiotics used, and relevant diagnostic and therapeutic interventions in the ICU.
- The Sequential Organ Failure Assessment (SOFA) score and Clinical Pulmonary Infection Score (CPIS) were calculated on the day of enrolment (day 1) and then on days 3, 7, and 14. Patients were monitored daily for evidence of infection.
- The duration of mechanical ventilation, length of ICU stay, and length of hospital stay were recorded.
- The occurrence of myocardial ischemia or infarction was assessed until day 28. Serum levels of creatine kinase, ALT, and AST were measured.
Patients were randomly allocated to simvastatin (60 mg) or control given via a nasogastric tube or orally from study inclusion to ICU discharge, death, or day 28, whichever occurred first. Simvastatin or control were started on the same day as antibiotic therapy for suspected VAP. The simvastatin dosage was halved in patients with renal failure (creatinine clearance <30 mL/min). A computer-generated random- number table was prepared by statisticians to assign patients in blocks of 4 to receive either simvastatin or control.
Block size was unknown to the investigators, who was enrolled the patients and then called the statistics department to obtain the randomization and treatment numbers after checking the inclusion and non-inclusion criteria Outcome The primary outcome was the day-28 mortality rate. Secondary outcomes were ICU mortality rates; number of days outside the ICU between day 1 and day 28; and number of ventilator-free days (after successful weaning) between day 1 and both day 28.
Successful weaning was defined as spontaneous breathing for at least 48 hours after disconnection of the ventilator.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients were randomly allocated to simvastatin (60 mg) or control given via a nasogastric tube or orally from study inclusion to ICU discharge, death, or day 28, whichever occurred first. Simvastatin or control were started on the same day as antibiotic therapy for suspected VAP. The simvastatin dosage was halved in patients with renal failure (creatinine clearance <30 mL/min). A computer-generated random- number table was prepared by statisticians to assign patients in blocks of 4 to receive either simvastatin or control. Block size was unknown to the investigators, who was enrolled the patients and then called the statistics department to obtain the randomization and treatment numbers after checking the inclusion and non-inclusion criteria.
| Arm | Type | Receives |
|---|---|---|
| simvastatin group | Active comparator | Drug: Simvastatin68 patients who had a ventilator associated pneumonia received simvastatin |
| control group | No intervention | –68 patients who had a ventilator associated pneumonia not received simvastatin |
Who may qualify
- Ages
- 29 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who suspected to had VAP defined as a modified Clinical Pulmonary Infection Score (CPIS) of at least 5 and if they underwent quantitative bacteriological cultures of bronchoalveolar lavage (BAL) fluid, a protected telescopic catheter (PTC), or an endotracheal aspirate. The modified CPIS is based on body temperature, blood leukocyte count, amount and appearance of tracheal secretions, ratio of partial pressure of oxygen (PaO2) to fraction of inspired oxygen, acute respiratory distress syndrome (ARDS), and infiltrates on chest radiography. The total can range from 1 to 10 points (Luna et al., 2003).
- Patients were included only for the first episode of suspected VAP.
Key exclusion criteria (13 listed)
- o Statin therapy at intubation
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 |
|---|---|---|
| Simvastatinsimvastatin 60 mg tab | Drug | simvastatin group |
Primary outcome
The primary outcome was the day-28 mortality rate.
Time frame: 28 day
asses effect of statin on mortality in ventilator associated pneumonia patient
3 secondary outcomes
ICU mortality rates
Time frame: between day 1 and day 28
number of days outside the ICU between day 1 and day 28
Time frame: between day 1 and day 28
number of ventilator-free days (after successful weaning) between day 1 and both day 28.
Time frame: between day 1 and day 28
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 9 Feb 2022.
- 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.
YOUSEF FAWZY principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin in people with VAP - 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 13 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 9 Feb 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The primary outcome was the day-28 mortality rate. (time frame: 28 day). 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 9 Feb 2022.