Ongoing studies
Studies conducted via ACTION Sweden and studies supported by the network
RECOVERY – Pneumonia and Influenza
Title: Randomised Evaluation of COVID-19 Therapy (RECOVERY)
Type of study (interventional/observational): Interventional study
Study design: European multicenter study in which hospitalized patients with community-acquired pneumonia or influenza are randomized to receive either Dexamethasone treatment or standard care (without Dexamethasone). This is a platform trial, meaning the number of included patients is not predefined, and there is also the possibility to randomize to antiviral treatment in the case of influenza.
Primary outcome: 28-day mortality.
Participating centers in Sweden: Stockholm (Karolinska Huddinge, Södersjukhuset, St. Göran), Gothenburg, Lund, Umeå, Linköping, Örebro, and Kalmar.
Participating European countries: UK, Sweden, Netherlands, France, Belgium, Italy, Spain, Portugal, Estonia, Romania.
Hypothesis/Objective: To study the effect of Dexamethasone in community-acquired pneumonia and influenza. Which patient groups benefit from Dexamethasone, and which groups may potentially be harmed?
Principal Investigator/Responsible contact: Kristoffer Strålin kristoffer.stralin@ki.se
ORAL
Title: ORAL - Partial oral antibiotic treatment for bacterial brain abscess: An open-label randomised non-inferiority trial (ORAL)
Type of study (interventional/observational): Interventional study
Study design: A total of 450 patients, of which 70 are in Sweden. Two arms where patients are randomized to either standard treatment or switch to oral antibiotics after 2 weeks.
Participating centers: Karolinska, Gothenburg, Lund, Uppsala, Linköping, Umeå, Örebro. Conducted in Denmark, Sweden, the Netherlands, France, and Australia.
Hypothesis/Objective: Early switch to oral antibiotic therapy is as effective as prolonged intravenous therapy in patients with brain abscess.
Principal Investigator/Responsible contact: Pontus Naucler, PI in Sweden pontus.naucler@ki.se
Use of New Antibiotics
Title: Use of New Antibiotics in Swedish Hospitals
Type of study (interventional/observational): Observational study
Study design: Prospective inclusion of patients treated with ceftazidime-avibactam, ceftolozane-tazobactam, meropenem-vaborbactam, imipenem-relebactam, cefiderocol, or intravenous fosfomycin over a 12-month period.
Participating centers: Gothenburg, Linköping, Lund, Solna, Umeå, Uppsala, Örebro.
Hypothesis/Objective: To map how new antibiotics are used in Swedish hospitals. Indications for treatment, clinical and microbiological outcomes, and resistance development will be evaluated.
Principal Investigators/Contacts: Thomas Tängdén and Lisa Faxén, Uppsala University Hospital Thomas.Tangden@medsci.uu.se
Pharmacokinetics of Beta-lactam Antibiotics
Title: Pharmacokinetics of Beta-lactam Antibiotics in Patients Treated for Infective Endocarditis
Type of study (interventional/observational): Observational study
Study design: Prospective inclusion of patients treated with beta-lactam antibiotics for confirmed or suspected endocarditis. Repeated sampling is performed to assess antibiotic concentrations and pharmacokinetics.
Participating centers: Gothenburg, Lund, Solna, Uppsala.
Hypothesis/Objective: Using mathematical modeling to determine how patient-specific factors affect the pharmacokinetics of antibiotics, with the goal of enabling simulation of optimized and individualized dosing for future patients.
Principal Investigators/Contacts: Thomas Tängdén and Lisa Faxén, Uppsala University Hospital Thomas.Tangden@medsci.uu.se
COMeBAC – Penicillin for Penicillin-Susceptible S. aureus (PSSA)
Title: COMeBAC – Randomized, controlled clinical trial comparing treatment with cloxacillin versus benzylpenicillin for bacteremia caused by penicillin-susceptible Staphylococcus aureus (PSSA)
Type of study (interventional/observational): Interventional study
Study design: Open-label, randomized, controlled study comparing treatment with benzylpenicillin and cloxacillin in adult patients with PSSA bacteremia. Dosage and duration of treatment will follow national clinical guidelines based on infection diagnosis.
Number of subjects: 420
Participating centers: Lund, Malmö, Kristianstad, Helsingborg, Gothenburg, Uppsala, Västerås, Örebro, Karlskrona, and Stockholm.
Hypothesis/Objective: To assess whether benzylpenicillin is a better treatment than cloxacillin for bacteremia caused by penicillin-susceptible S. aureus.
Principal Investigator/Contact: Malin Hagstrand Aldman, Department of Infectious Diseases, Skåne University Hospital, Lund Malin.hagstrand_aldman@med.lu.se
SNAP – The World's Largest Clinical Trial on S. aureus Bacteremia
Title: Staphylococcus aureus Network Adaptive Platform (SNAP)
Type of study (interventional/observational): Interventional study
Study design: Open-label randomized controlled adaptive platform trial conducted at multiple hospitals in several countries. Participants may be randomized to several different interventions simultaneously. Over time, old interventions can be removed and new ones added. The intention is for this trial to run indefinitely or to recruit at least 7,000 participants globally.
Participating centers: Helsingborg, Malmö, Lund, Karolinska, Östersund, Umeå, Skövde, and Västerås.
Hypothesis/Objective: To evaluate how various interventions affect all-cause mortality within 90 days in patients with S. aureus bacteremia.
Current domains in Sweden and the EU include:
• Basic antibiotics (PSSA: Penicillin G vs Cloxacillin; MSSA: Cloxacillin vs Cefazolin; MRSA: Vancomycin vs Vancomycin + Cefazolin)
• Adjunctive antibiotics (5 days of Clindamycin vs no adjunctive therapy)
• Early oral switch (continued IV therapy for at least 10 days vs switch to oral antibiotics on day 7±2 or 14±2, depending on infection focus and resolution)
Principal Investigator/Contact: Jonas Tverring, Department of Infectious Diseases, Helsingborg Hospital jonas.tverring@med.lu.se
CIED-OUT
Title: Cardiac Implantable Electronic Device removal versus full coUrse medical Treatment (CIED-OUT)
Type of study (interventional/observational): Interventional study
Study design: Patients with bloodstream infections due to Staphylococcus, Streptococcus, or Enterococcus, or with left-sided endocarditis and the presence of a CIED (Cardiac Implantable Electronic Device) but no vegetations on echocardiography, are randomized to either device extraction + antibiotics or antibiotics only.
Participating centers: Led from Copenhagen by Emil Fosbøl; in Sweden, Lund has started including patients and Stockholm is in the process of joining.
Hypothesis/Objective: CIED extraction may be unnecessary in cases without echocardiographic signs of CIED infection.
Principal Investigator/Contact in Sweden: Magnus Rasmussen, Lund, magnus.rasmussen@med.lu.se