Staphylococcus Aureus BacteraemiaPhase 4COMeBACNCT06726395
Comparison of Cloxacillin and Benzylpenicillin in Penicillin Susceptible S. Aureus Bacteraemia
A Phase 4 study testing Penicillin G_1200mg and cloxacillin in people with Staphylococcus Aureus Bacteraemia and Staphylococcal Bacteraemia, run by Region Skane at 1 site in Sweden.
Trial summary
The goal of this study is to investigate if benzylpenicillin is a better treatment option than cloxacillin in patients with penicillin-susceptible Staphylococcus aureus bacteraemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus Bacteraemia, Staphylococcal Bacteraemia, Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia)
- What is being tested?
- Penicillin G_1200mg and cloxacillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteSweden
- Study dates
- 10 Mar 2025to Jul 2028
- Phase
- Phase 4
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 with penicillin susceptible S. aureus bacteraemia (PSSA), and able to provide written informed consent.
Who cannot join
- allergy to penicillin,
- inability to give informed consent,
- concomitant growth of other clinically significant bacteria in blood cultures
- neutropenia
- -≥ 96h with prior antibiotics
- When the per oral follow up medication can not be flukloxacillin or penicillinV/Amoxicillin (ie prosthetic joint infection)
- Patients in terminal palliation, where death is expected within 7 days.
- Where the treating physician believes cloxacillin is not a first-line treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lisa I Påhlman, PhD, MD contact
Sweden1 site, 1 recruiting
- Recruiting
Skånes universitetssjukhus, Region Skåne
Lund, 22467
MD, PhD, Malin Hagstrand Aldman, PhD, MD, +46768766308, malin.hagstrand-aldman@skane.se
Malin Hagstrand Aldman, PhD, MD
About this study
Official title: Randomized Controlled Clinical Trial Comparing Treatment With Cloxacillin Versus Benzylpenicillin in Bacteraemia Caused by Penicillin-susceptible Staphylococcus Aureus (PSSA)
The goal of this study is to investigate if benzylpenicillin is a better treatment option than cloxacillin in patients with penicillin-susceptible Staphylococcus aureus bacteraemia.
Read the detailed description
The overall research idea of is a RCT is to test the hypothesis that benzylpenicillin is superior to cloxacillin in the treatment of PSSA bacteraemia.
Population: Adult patients (>18 years) with PSSA bacteraemia will be eligible for enrolment in the study. Exclusion criteria are allergy to penicillin, inability to give informed consent, and concomitant growth of other clinically significant bacteria in blood cultures. We are planning a nation-wide study.
Intervention: Benzylpenicillin treatment of PSSA bacteraemia will be evaluated. As soon as S. aureus has been identified in blood cultures and the susceptibility testing indicates penicillin susceptibility (Two-three days from start of treatment), patients will be randomized to continue therapy with either cloxacillin or benzylpenicillin. The duration of treatment depends on the type of infection, and details about length of therapy and dosage will be decided by the specific patient diagnosis (i.e., endocarditis, arthritis). Repeated blood cultures and echocardiography are important in the diagnostic work-up of S. aureus bacteraemia and will be included in the study protocol. Patients will also be monitored regarding adverse events, such as liver and renal impairment, rash, diarrhoea, thrombophlebitis et c., and treatment failure, relapse, and mortality.
Control: The study drug (benzylpenicillin) will be compared to cloxacillin, which is the current drug of choice for methicillin susceptible S. aureus in Sweden. Both drugs will be used at clinically recommended doses, with appropriate adjustments for renal impairment if needed. Outcome: Primary outcome is; to be alive for 90 days without any complications. Complications are defined as having any of relapse (90 days after antibiotic finished), need of change or addition of antibiotics due to side effects or treatment failure or adverse events.
- Conditions
- Staphylococcus Aureus Bacteraemia, Staphylococcal Bacteraemia, Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia), Staphylococcus (S.) Aureus Infection
- Being tested
- Penicillin G_1200mg, cloxacillin
- Keywords
- Penicillin treatment, benzylpenicillin, cloxacillin, Penicillin susceptible S. aureus, Staphylococcus aureus bacteraemia
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penicillin G_1200mgDrug
Also called bensylpenicillin, benzylpenicillin
benzylpenicillin preferred dosing 1gx4
cloxacillinDrug
cloxacillin 2gx4
| Study group | Role | What they receive |
|---|---|---|
| Benzylpenicillin treatment | Experimental | Not described Receives: Drug: Penicillin G_1200mg |
| cloxacillin | Active comparator | Not described Receives: Drug: cloxacillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 90 days without any treatment complications
Complications are defined as having any of; relapse within 90 days after treatment finish, need of change or addition of antibiotics due to side effects or treatment failure or adverse events.
Measured: From enrollment to 90 days after end of treatment
Secondary outcomes (5)
Mortality at 90 days
All cause mortality within 90 days from enrollment
Measured: From enrollment to 90 days after end of treatment
Relapse 90 days after end of treatment
Relapse with positive culturing from sterile sites or high suscpition of clinical relapse
Measured: From enrollment to 90 days after end of treatment
Cumulative frequency of side effects within 90 days
all side effects registered as a cumulative frequence
Measured: From enrollment until 90 days.
Cumulative frequence of change or addition of antibiotic treatment due to sideeffects or treatment failure
Every time additional antibiotics or change in antibiotic treatment is made due to either side effects or treatment failure (according to treating doctor)
Measured: from enrollment to end of treatment duration up to 90 days
Decrease of Bacterial DNA in blood samples
Bacterial DNA tested the first 5 days during study treatment.
Measured: From enrollment and first 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start10 Mar 2025
- Primary completionApr 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus BacteraemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Observational
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malin Hagstrand Aldman, Region Skane
- Investigators
- Malin Hagstrand Aldman, PhD, MD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726395
- Sponsor's protocol ID
- 2023-506860-15-00
- Other IDs
- 2023-506860-15-00, 2023
- Acronym
- COMeBAC
- Status last verified
- Apr 2026
- First submitted
- 26 Nov 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To share the IPD is not supported by the Swedish ethical comite.