Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05813821 |
| Other study ID # |
HGG2022_01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2019 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
April 2023 |
| Source |
Hospital de Granollers |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Antimicrobial resistance (AMR) is one of the top ten public health threats facing humanity.
The misuse and overuse of antibiotics has been identified as a major factor in the
development of drug-resistant pathogens, and 30% of all antimicrobials administered in
Western acute hospitals are unnecessary or inappropriate. As a consequence, the establishment
of antimicrobial stewardship programmes (ASPs) has increased in hospitals over the past
decades.
Using ASPs to optimise antimicrobial use is critical to effectively fight infections, protect
patients and reduce AMR. ASPs can increase infection cure rates while reducing AMR, but it
has been reported that few of them are specifically targeted at surgical specialties or led
by surgeons.
Surgeons are actively involved in antibiotic prescribing and should therefore play an
important role in the development and leadership of ASPs in surgical departments.
Practice Guidelines have established recommendations for the wise use of antibiotics in
patients affected by intra-abdominal infection: early identification of sepsis, early
initiation of antimicrobial therapy and early control of the infectious focus. The literature
on the optimal duration of antibiotic treatment in surgery is sparse, but it seems that, if
the septic source has been effectively controlled, short courses of treatment show the same
results as longer courses.Compliance rates with the suggested duration of treatment in
evidence-based guidelines are low among the surgical community.
No specially designed ASPs for the reduction of treatment duration in surgery have been
reported. ASPs may be easy to introduce in a single hospital, but the feasibility of a
nationwide implementation of ASPs in a large and diverse hospital population is unclear.
This prospective, interventional, cohort study was aimed: to reduce the duration of
antimicrobial treatment in surgical departments by modifying their prescriptions through
educational and consensual interventions; and to assess the feasibility of implementing a
multi-centre ASP, leveraging a nationwide surveillance programme for healthcare-associated
infection.
It was hypothesised that a coordinated and guided implementation strategy, organised within a
consolidated infection surveillance network, would lead to the successful implementation of
the ASP and reduce antibiotic consumption in participating hospitals.
Description:
This is a multicenter, prospective, interventional, cohort study analysing the effect of an
antimicrobial stewardship intervention in surgery. The study uses data collected
prospectively leveraging an infection surveillance network.
4.1. Setting and patients. The 7VINCut antibiotic stewardship program started in 2019 at
national level to shorten the duration of antibiotic therapy in adult patients admitted to
surgical departments. Secondary objectives were to reduce the consumption of carbapenems in
surgical services and to reduce the consumption of other antibiotics with ecological impact
(piperacillin-tazobactam, amoxicillin/clavulanate, 3rd and 4th generation cephalosporins and
quinolones).
The prospective study was conducted between January 2019 and December 2022. Data from 32
hospitals participating in the network were included in the analysis.
All patients aged 18 years or older admitted to general and urological surgical services, who
received systemic antibiotic treatments lasting for 7 or more days were included. Patients
with antibiotics prescribed for surgical prophylaxis were excluded. Because to the
characteristics of the infections treated in Orthopedics and Vascular Surgery departments,
often requiring long-term treatments, the cases with diseases specific to these services
(osteomyelitis, diabetic foot, etc) were excluded.
4.2. Intervention. The intervention started with the dissemination of the project protocol to
all hospitals participating in the network, and a workshop for surgical and infection control
teams. This was a multidisciplinary project in which hospitals were invited to form a
specific surgical ASP with surgeons, pharmacists and infectious disease specialists.
Participating institutions established local teams with the support of senior hospital
leaders to facilitate the implementation of the ASP.
The interventional ASP relied on an audit and feedback strategy to issue recommendations
aimed at reducing the duration of antibiotic treatment regimens and reducing the use of drugs
with a particular impact on microbial ecology.
All patients hospitalized in the targeted departments were prospectively analyzed weekly. A
computerized alert allowed the ASP team to identify those patients whose antibiotic treatment
lasted longer than 7 days. The team meet to discuss the appropriateness of each antibiotic
treatment, issuing a written recommendation for each patient. The intervention was performed
only once for each patient, except if they had a new focus of infection. The recommendations
available for prolonged treatments were: withdraw, maintain, de-escalate, broaden, change
route, optimize dose, no recommendation. The recommendations were discussed in the Surgery
Departments and implemented if deemed necessary. Adherence to the recommendations was
recorded 48 hours later by the ASP team.
Although the intervention focused on the duration of antibiotic treatment, the stewardship
team added recommendations on the microbiological appropriateness of the treatments and the
use of broad-spectrum antibiotics, especially carbapenems. Before implementation of the
program in the hospital, a series of educational initiatives related to antibiotic management
in the Department of Surgery were introduced.
The prescriptions analyzed were either pathogen directed or empirical broad spectrum
antibiotic treatments. Before making the ASP recommendations, the microbiological results
were reviewed, when available. The appropriateness of the empirical antibiotics prescribed
according to the hospital antibiotic guideline was also reviewed.
The main outcome evaluated was the percentage of patients subjected to more than 7 days of
antibiotic therapy. Other outcomes were: percentage of new patients on antibiotic treatment
>7 days out of the total number of patients on antibiotic treatment admitted to the surgical
services; percentage of adherence to recommendations.
Variables such as type of infection, quality of control of infectious focus (good, uncertain,
bad) for which antibiotic treatment was indicated was reported, use of broad spectrum
antibiotics, route of administration, and microbiological adequacy have been analyzed.
4.3. Ethics and statistics. The study was approved by the Research Ethics Committee of the
Hospital General Universitari de Granollers with code 20222042, which did not consider an
informed consent document necessary. The project will be reported according to the
"Strengthening the reporting of cohort, cross-sectional and case-control studies in surgery"
(STROCSS 2021) criteria.
Data was entered into a computerized database that was analyzed using the IBM SPSS program
(v. 21.0, Chicago, IL, USA). The evolution of the percentage of new patients undergoing a
prolonged antibiotic treatment related to the total number of patients on antibiotic
treatment has been evaluated by simple linear regression. The linear relationship was tested
by ANOVA tests and Pearson's correlation coefficients (Pc) were obtained. Values of p ≤ 0.05
were considered statistically significant. A bilateral distribution was assumed for all p
values.
