SurgeryeSATPNCT03456635
Improving Perioperative Antimicrobial Prophylaxis by the Use of a Computerized Decision Support System
A study testing guided antimicrobial prophylaxis in people with Surgery, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
To evaluate the impact of using a computerized decision program on the adequacy of the perioperative antimicrobial prophylaxis Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- guided antimicrobial prophylaxis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2017to 31 Jul 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All elective \& emergency surgeries done by neurosurgery, orthopaedics, cardiovascular and digestive specialties made at University Hospitals of Geneva
Who cannot join
- Patients < 40 kgs
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the impact of using a computerized decision program on the adequacy of the perioperative antimicrobial prophylaxis
Read the detailed description
Adequacy rate of surgical antimicrobial prophylaxis, helped by a computerized decision support system, according to the internal guidelines considering the aspects: drug choice, dosing, timing, and re-dosing
- Conditions
- Surgery
- Being tested
- guided antimicrobial prophylaxis
- Keywords
- antimicrobial, prophylaxys, CDSS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided antimicrobial prophylaxisOther
During the intervention period, antimicrobial prophylaxis decisions will be guided by a computerized program
| Study group | Role | What they receive |
|---|---|---|
| usual antimicrobial prophylaxys | No intervention | standard of care: perioperative antimicrobial prophylaxis without computerized decision support system |
| guided antimicrobial prophylaxis | Experimental | perioperative antimicrobial prophylaxis guided by a computerized decision support system Receives: Other: guided antimicrobial prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy rate of surgical antimicrobial prophylaxis
Adequacy rate of surgical antimicrobial prophylaxis according to the internal guidelines
Measured: baseline & 1 year
Secondary outcomes (1)
Incidence of surgical site infections
Incidence of surgical site infections in subgroups: hip \& knee, colon \& rectum, lumbar neurosurgeries and heart surgeries
Measured: baseline & 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jul 2023 (estimated)
Why it stopped: Due to COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- quasi-experimental study Time-series analysis, with a non-equivalent variable prospective Quality Improvement project
- Masking
- None (open label)
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Porto, University of Sao Paulo
- Responsible party
- Principal investigator, Américo Agostinho, University Hospital, Geneva
- Investigators
- Americo Agostinho, BSc, Principal investigator, Clinical nurse specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456635
- Sponsor's protocol ID
- 2016-01881
- Other IDs
- 2016
- Acronym
- eSATP
- Status last verified
- Jan 2022
- First submitted
- 22 Feb 2018
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Perioperative Antimicrobial Prophylaxis by the Use of a Computerized Decision Support System
- ClinicalTrials.gov ID
- NCT03456635
- Acronym / sponsor ID
- eSATP / 2016-01881
- Conditions
- Surgery
- Keywords
- antimicrobial, prophylaxys, CDSS
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to COVID
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Universidade do Porto, University of Sao Paulo
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 7 Mar 2018 (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.
To evaluate the impact of using a computerized decision program on the adequacy of the perioperative antimicrobial prophylaxis
Detailed description
Adequacy rate of surgical antimicrobial prophylaxis, helped by a computerized decision support system, according to the internal guidelines considering the aspects: drug choice, dosing, timing, and re-dosing
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- quasi-experimental study Time-series analysis, with a non-equivalent variable prospective Quality Improvement project
| Arm | Type | Receives |
|---|---|---|
| usual antimicrobial prophylaxys | No intervention | –standard of care: perioperative antimicrobial prophylaxis without computerized decision support system |
| guided antimicrobial prophylaxis | Experimental | Other: guided antimicrobial prophylaxisperioperative antimicrobial prophylaxis guided by a computerized decision support system |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All elective \& emergency surgeries done by neurosurgery, orthopaedics, cardiovascular and digestive specialties made at University Hospitals of Geneva
Key exclusion criteria (1 listed)
- Patients < 40 kgs
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 |
|---|---|---|
| guided antimicrobial prophylaxisDuring the intervention period, antimicrobial prophylaxis decisions will be guided by a computerized program | Other | guided antimicrobial prophylaxis |
Primary outcome
Adequacy rate of surgical antimicrobial prophylaxis
Time frame: baseline & 1 year
Adequacy rate of surgical antimicrobial prophylaxis according to the internal guidelines
1 secondary outcome
Incidence of surgical site infections
Time frame: baseline & 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 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.
Americo Agostinho, BSc principal investigator
Clinical nurse specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guided antimicrobial prophylaxis in people with Surgery, run by University Hospital, Geneva at 1 site in Switzerland.
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: paused, as of the sponsor's last update on 20 Jan 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 Switzerland. 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?
Adequacy rate of surgical antimicrobial prophylaxis (time frame: baseline & 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 20 Jan 2022.