COMeBAC- COMparison between Bensypenicillin And Cloxacillin treatment in PSSA

Phase 1

• Conditions: Staphylococcus aureus bacteraemia; MedDRA version: 21.1Level: LLTClassification code: 10058863Term: Staphylococcus aureus bacteraemia Class: 10021881; MedDRA version: 21.1Level: LLTClassification code: 10058887Term: Staphylococcus aureus bacteremia Class: 10021881; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2023-506860-15-00
• Lead Sponsor: Region Skane

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-09
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

> 18 years with penicillin susceptible S. aureus bacteraemia, Abiliaty to give informed consent

Exclusion Criteria

Allergy to penicillin, More than one significant bacterial species in blood cultures., = 96h of antibiotic treatment before inclusion, Verified or strong suspicion of prosthetic joint infection, Terminal ill patients with a suscpected survival less than 7 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Compare clinical outcome in patients with penicillin susceptible Staphylococcus aureus bacteraemia treated with bensylpenicillin compared to cloxacillin.;Secondary Objective: Differences in relapse rate, up to 90 days after treatment stop, when treated with bensylpenicillin vs. cloxacillin, Differences in 90 day mortality if treated with bensylpenicillin compared to cloxacillin?, Differences in time with presence of bacterial DNA when treated with bensylpenicillin vs. cloxacillin, Are side effects and advers events more common in patients with PSSA, when treated with cloxacillin than bensylpenicillin, Differences in length of iv antibiotics between bensylpenicillin and cloxacillin;Primary end point(s): Alive at day 90 without complications. Complications defined as; relapse within 90 days from finishing antibiotic treatment, Change or addition of antibiotic treatment due to adverse events or clinical failure.