Ventilator Associated PneumoniaNCT04348227
How COVID-19 Virus Outbreak Affects Antimicrobial Resistance in a Low-middle-income Country's ICU?
An observational study of Ventilator Associated Pneumonia, run by Hôpital Universitaire Fattouma Bourguiba at 1 site in Tunisia.
Trial summary
A previous study showed a high incidence of ventilator-associated pneumonia to multidrug resistant pathogens in our ICU. That has been related to lack of compliance to hand hygiene among health care providers in ou ICU. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Enhanced hygiene measures
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2019to 4 Feb 2021
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted in ICU in the period of the study, requiring mechanical ventilation for more than 24 hours
Who may be able to join
- Patients requiring mechanical ventilation for more than 24 hours
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Department of anesthesia and intensive care, Fattouma Bourguiba Hospital
Monastir, 5000
About this study
A previous study showed a high incidence of ventilator-associated pneumonia to multidrug resistant pathogens in our ICU. That has been related to lack of compliance to hand hygiene among health care providers in ou ICU.
Read the detailed description
A single-center cohort study performed in the department of Anesthesia and Intensive Care in our Hospital. All endotracheal isolates realised in the period of study are collected from the Department of Microbiology of our Hospital.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Enhanced hygiene measures
- 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.
Enhanced hygiene measuresBehavioural
Wether or not hygiene measures dictated by the pandemic of severe acute respiratory syndrome coronavirus 19 , reduce multi drug resistant pathogens isolated in endotracheal aspirates.
| Study group | Role | What they receive |
|---|---|---|
| Before pandemic is declared | Positive endotracheal aspirates addressed from January 1st 2019 to January 1st 2020 | |
| After pandemic is declared | Positive endotracheal aspirates addressed from February1st 2020 to February 1st 2021 Receives: Behavioral: Enhanced hygiene measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDR pathogens in endotracheal aspirates
Incidence of MDR bacteria in endotracheal aspirates
Measured: 1 year
Secondary outcomes (1)
Microorganisms in endotracheal aspirates
Incidence of microorganisms in endotracheal aspirates
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 posted16 Apr 2020
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion4 Feb 2021 (estimated)
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
- Other
- Enrolment
- 120 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Fattouma Bourguiba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khemili Malek, Hôpital Universitaire Fattouma Bourguiba
- Investigators
- Malek Khemili, Resident, Principal investigator, Department of anesthesia and intensive care, Fattouma Bourguiba Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348227
- Sponsor's protocol ID
- KM2020-1
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- 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 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How COVID-19 Virus Outbreak Affects Antimicrobial Resistance in a Low-middle-income Country's ICU?
- ClinicalTrials.gov ID
- NCT04348227
- Acronym / sponsor ID
- KM2020-1
- Conditions
- Ventilator Associated Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hôpital Universitaire Fattouma BourguibaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 4 Feb 2021 (estimated)
- First posted
- 16 Apr 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.
A previous study showed a high incidence of ventilator-associated pneumonia to multidrug resistant pathogens in our ICU. That has been related to lack of compliance to hand hygiene among health care providers in ou ICU.
Detailed description
A single-center cohort study performed in the department of Anesthesia and Intensive Care in our Hospital. All endotracheal isolates realised in the period of study are collected from the Department of Microbiology of our Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before pandemic is declared | – | –Positive endotracheal aspirates addressed from January 1st 2019 to January 1st 2020 |
| After pandemic is declared | – | Behavioral: Enhanced hygiene measuresPositive endotracheal aspirates addressed from February1st 2020 to February 1st 2021 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted in ICU in the period of the study, requiring mechanical ventilation for more than 24 hours
Key inclusion criteria (1 listed)
- Patients requiring mechanical ventilation for more than 24 hours
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Enhanced hygiene measuresWether or not hygiene measures dictated by the pandemic of severe acute respiratory syndrome coronavirus 19 , reduce multi drug resistant pathogens isolated in endotracheal aspirates. | Behavioural | After pandemic is declared |
Primary outcome
MDR pathogens in endotracheal aspirates
Time frame: 1 year
Incidence of MDR bacteria in endotracheal aspirates
1 secondary outcome
Microorganisms in endotracheal aspirates
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Ventilator Associated Pneumonia
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
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)
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.
Malek Khemili, Resident principal investigator
Department of anesthesia and intensive care, Fattouma Bourguiba Hospital
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 Hôpital Universitaire Fattouma Bourguiba at 1 site in Tunisia.
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 1 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 17 Apr 2020. 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 Tunisia. 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?
Results are not available in the source record.
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?
MDR pathogens in endotracheal aspirates (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 17 Apr 2020.