Ventilator Associated PneumoniaNCT04097899
Antimicrobial Stewardship Program and Ventilator Associated Pneumonia
An observational study of Ventilator Associated Pneumonia, run by Zagazig University.
Trial summary
Antibiotic Stewardship Programs (ASPs) help clinicians improve the quality of patient care and improve patient safety through increased infection cure rates, reduced treatment failures; however, there are different techniques, with variable results, of its application including what is called ASPs bundle and there is… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- implementation of antimicrobial stewardship comprehensive care bundle program on ventilator associated pneumonia patients
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 31 Dec 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, ≥18 years, who were intubated and mechanically ventilated for more than 48 hours in ICU and showing clinical criteria of VAP. Diagnosis was based on the clinical pulmonary infection score then it was confirmed microbiologically by culture results. Clinical VAP criteria included the presence of a new or progressive pulmonary infiltrates on chest radiograph, fever (greater than 38.3°C), leukocytosis or leucopenia and appearance of purulent tracheobronchial secretions
Who may be able to join
- Patients, ≥18 years, who were intubated and mechanically ventilated for more than 48 hours in ICU and showing clinical criteria of VAP
Who cannot join
- Patients on immunosuppressive drugs.
- Patient with chronic lung disease, chronic liver disease\& chronic renal disease.
- Immunocompromised Patients.
- Patients intubated and mechanical ventilated outside the ICU before admission.
- Patients manifested clinically with picture suggestive of VAP but less than 48 hours on mechanical ventilation.
About this study
Official title: Impact of Implementation of Antimicrobial Stewardship Comprehensive Care Bundle Program on Ventilator Associated Pneumonia in Surgical Intensive Care Unit
Antibiotic Stewardship Programs (ASPs) help clinicians improve the quality of patient care and improve patient safety through increased infection cure rates, reduced treatment failures; however, there are different techniques, with variable results, of its application including what is called ASPs bundle and there is a need to investigate the effectiveness of implementing a comprehensive care bundle program including the key components of ASPs and the key items of infection control measures, this program can be called Antimicrobial Stewardship Comprehensive Care Bundle Program (ASCCBP).
Read the detailed description
Survey experimental study will be done in the first 6 months as regard antimicrobial drugs pattern and organism's sensitivity and resistance pattern in VAP patients.
In the next six months, clinical implementation of ASPs and infection control bundle will be applied on VAP patients. Then, in the later six months the investigators will study the outcome of VAP patients as regard:
- Amount of cost of antibiotics.
- Appropriates of antibiotic use (initiation, duration \& time of discontinuation).
- Rate of resistance
- Clinical outcome, infection rate \&length of stay.
Regular reports on antibiotic use and resistance will be admitted to relevant staff every one month. Also, audit and feedback about resistance and optimal prescribing will be applied every one month for ICU stuff as an open discussion.
The stewardship consulting team will include microbiologist with clinical experience in the field of antibiotic use and infection control. Stewardship team also will include the relevant ICU staff and an experienced clinical pharmacist.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- implementation of antimicrobial stewardship comprehensive care bundle program on ventilator associated pneumonia patients
- 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.
implementation of antimicrobial stewardship comprehensive care bundle program on ventilator associated pneumonia patientsOther
Construction of a comprehensive care bundle educational program. This program consisted of many elements: Antimicrobial stewardship programs, VAP bundles and infection control policy implementation and the investigators studied the impact of this program on:
- Antibiotics cost.
- Appropriates of antibiotic use (initiation, duration \& time of discontinuation).
- Rate of resistance
- Clinical outcome, infection rate \&length of stay.
| Study group | Role | What they receive |
|---|---|---|
| Group A in preimplementation phase | Patient and antibiotic related data were collected to calculate and define; ventilator associated pneumonia incidence, mean ventilation days and mean length of stay, antibiotic selection, antibiotic cost, antibiotic susceptibility pattern, antibiotic consumption. | |
| Group B in postimplementation phase | The appropriateness of antibiotic use (selection, initiation, duration \& time of discontinuation) before and after implementing the educational program was compared, calculation of the change in the ventilator associated pneumonia incidence \& length of ICU stay, calculation of the change in the rate of antibiotic resistance and calculation of the cost change of antibiotics used after implementing the educational program. Receives: Other: implementation of antimicrobial stewardship comprehensive care bundle program on ventilator associated pneumonia patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in ventilator associated pneumonia incidence
After implementation of the Antimicrobial Stewardship Comprehensive Care Bundle Program (ASCCBP), the percentage of VAP incidence was measured to assess the effectiveness of the program.
Measured: 18 months
change in antibiotic resistance pattern
measuring the change in sensitivity and resistance pattern of antibiotics used in ICU was done by assessing the change in the sputum culture and sensitivity results.
Measured: 18 months
Secondary outcomes (2)
ventilation days
Days of mechanical ventilation of each patient were measured to calculate the difference before and after implementation of the program.
Measured: 18 months
antibiotic cost
costs of antibiotics by Egyptian pounds were calculated to assess the effectiveness of the program
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 Jul 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
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.
- 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
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Michael Adel Shaker, Zagazig University
- Investigators
- michael shaker, MD, Principal investigator, faculty of medicine, Helwan university, EgyptHeba Matar, MD, Study director, faculty of medicine, zagazig university, Egyptsahar saad-eldeen, MD, Study director, faculty of medicine, zagazig university, EgyptRehab elsokkary, MD, Study director, faculty of medicine, zagazig university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097899
- Sponsor's protocol ID
- 2143/11-5-2015
- Status last verified
- Sep 2019
- First submitted
- 31 Aug 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data could be shared
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Implementation of Antimicrobial Stewardship Comprehensive Care Bundle Program on Ventilator Associated Pneumonia in Surgical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04097899
- Acronym / sponsor ID
- 2143/11-5-2015
- Conditions
- Ventilator Associated Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 20 Sep 2019 (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.
Antibiotic Stewardship Programs (ASPs) help clinicians improve the quality of patient care and improve patient safety through increased infection cure rates, reduced treatment failures; however, there are different techniques, with variable results, of its application including what is called ASPs bundle and there is a need to investigate the effectiveness of implementing a comprehensive care bundle program including the key components of ASPs and the key items of infection control measures, this program can be called Antimicrobial Stewardship Comprehensive Care Bundle Program (ASCCBP).
Detailed description
Survey experimental study will be done in the first 6 months as regard antimicrobial drugs pattern and organism's sensitivity and resistance pattern in VAP patients.
In the next six months, clinical implementation of ASPs and infection control bundle will be applied on VAP patients. Then, in the later six months the investigators will study the outcome of VAP patients as regard:
- Amount of cost of antibiotics.
- Appropriates of antibiotic use (initiation, duration \& time of discontinuation).
- Rate of resistance
- Clinical outcome, infection rate \&length of stay.
Regular reports on antibiotic use and resistance will be admitted to relevant staff every one month. Also, audit and feedback about resistance and optimal prescribing will be applied every one month for ICU stuff as an open discussion.
The stewardship consulting team will include microbiologist with clinical experience in the field of antibiotic use and infection control. Stewardship team also will include the relevant ICU staff and an experienced clinical pharmacist.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A in preimplementation phase | – | –Patient and antibiotic related data were collected to calculate and define; ventilator associated pneumonia incidence, mean ventilation days and mean length of stay, antibiotic selection, antibiotic cost, antibiotic susceptibility pattern, antibiotic consumption. |
| Group B in postimplementation phase | – | Other: implementation of antimicrobial stewardship comprehensive care bundle program on ventilator associated pneumonia patientsThe appropriateness of antibiotic use (selection, initiation, duration \& time of discontinuation) before and after implementing the educational program was compared, calculation of the change in the ventilator associated pneumonia incidence \& length of ICU stay, calculation of the change in the rate of antibiotic resistance and calculation of the cost change of antibiotics used after implementing the educational program. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, ≥18 years, who were intubated and mechanically ventilated for more than 48 hours in ICU and showing clinical criteria of VAP. Diagnosis was based on the clinical pulmonary infection score then it was confirmed microbiologically by culture results. Clinical VAP criteria included the presence of a new or progressive pulmonary infiltrates on chest radiograph, fever (greater than 38.3°C), leukocytosis or leucopenia and appearance of purulent tracheobronchial secretions
Key inclusion criteria (1 listed)
- Patients, ≥18 years, who were intubated and mechanically ventilated for more than 48 hours in ICU and showing clinical criteria of VAP
Key exclusion criteria (5 listed)
- Patients on immunosuppressive drugs.
- Patient with chronic lung disease, chronic liver disease\& chronic renal disease.
- Immunocompromised Patients.
- Patients intubated and mechanical ventilated outside the ICU before admission.
- Patients manifested clinically with picture suggestive of VAP but less than 48 hours on 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implementation of antimicrobial stewardship comprehensive care bundle program on ventilator associated pneumonia patientsConstruction of a comprehensive care bundle educational program. This program consisted of many elements: Antimicrobial stewardship programs, VAP bundles and infection control policy implementation and the investigators studied the impact of this program on: * Antibiotics cost. * Appropriates of antibiotic use (initiation, duration \& time of discontinuation). * Rate of resistance * Clinical outcome, infection rate \&length of stay. | Other | Group B in postimplementation phase |
Primary outcome
change in ventilator associated pneumonia incidence
Time frame: 18 months
After implementation of the Antimicrobial Stewardship Comprehensive Care Bundle Program (ASCCBP), the percentage of VAP incidence was measured to assess the effectiveness of the program.
change in antibiotic resistance pattern
Time frame: 18 months
measuring the change in sensitivity and resistance pattern of antibiotics used in ICU was done by assessing the change in the sputum culture and sensitivity results.
2 secondary outcomes
ventilation days
Time frame: 18 months
antibiotic cost
Time frame: 18 months
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 20 Sep 2019.
- Individual participant dataSharing planned: Yes. All data could be shared
Related trials for Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Not yet recruiting
Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Not yet recruiting
Closed Versus Open Endotracheal Suctioning and Ventilator-Associated Pneumonia in Severe Traumatic Brain Injury
Ventilator-associated Pneumonia, Traumatic Brain Injury
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.
michael shaker, MD principal investigator
faculty of medicine, Helwan university, Egypt
Heba Matar, MD study director
faculty of medicine, zagazig university, Egypt
sahar saad-eldeen, MD study director
faculty of medicine, zagazig university, Egypt
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia, run by Zagazig 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 1 inclusion and 5 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 20 Sep 2019. 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?
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?
change in ventilator associated pneumonia incidence (time frame: 18 months). 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?
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 20 Sep 2019.