COMeBAC- COMparison between Bensypenicillin And Cloxacillin treatment in PSSA

Start 11 Jun 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 14 sites · Protocol COMeBAC

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Ongoing, recruiting

Participants planned 420

Countries 1

Sites 14

Staphylococcus aureus bacteraemia

Compare clinical outcome in patients with penicillin susceptible Staphylococcus aureus bacteraemia treated with bensylpenicillin compared to cloxacillin.

Key facts

Sponsor: Region Skane
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trial duration: 11 Jun 2024 → ongoing
Decision date (initial): 2024-02-09
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: Svenska läkaresällskapet · Forum Söder

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

Compare clinical outcome in patients with penicillin susceptible Staphylococcus aureus bacteraemia treated with bensylpenicillin compared to cloxacillin.

Secondary objectives 5

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

Conditions and MedDRA coding

Staphylococcus aureus bacteraemia

Version	Level	Code	Term	System organ class
21.1	LLT	10058863	Staphylococcus aureus bacteraemia	10021881
21.1	LLT	10058887	Staphylococcus aureus bacteremia	10021881

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

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

Exclusion criteria 5

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Bensylpenicillin Meda 1 g respektive 3 g pulver till injektions/infusionsvätska, lösning

PRD840134 · Product

Active substance: Benzylpenicillin Sodium
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 12 g gram(s)
Max total dose: 600 g gram(s)
Max treatment duration: 7 Week(s)
Authorisation status: Authorised
ATC code: J01CE01 — BENZYLPENICILLIN
Marketing authorisation: 3521
MA holder: MEDA AB
MA country: Sweden
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Comparator 1

Cloxacillin Navamedic 2 g pulver till injektions-/infusionsvätska, lösning

PRD10368304 · Product

Active substance: Cloxacillin
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 12 g gram(s)
Max total dose: 600 g gram(s)
Max treatment duration: 7 Week(s)
Authorisation status: Authorised
ATC code: J01CF02 — CLOXACILLIN
Marketing authorisation: 63884
MA holder: NAVAMEDIC ASA
MA country: Sweden
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Skane

Sponsor organisation: Region Skane
Address: Dockplatsen 26, Malmo S:t Petri Malmo S:t Petri
City: Malmo
Postcode: 211 74
Country: Sweden

Scientific contact point

Organisation: Region Skane
Contact name: Malin Hagstrand Aldman

Public contact point

Organisation: Region Skane
Contact name: Malin Hagstrand Aldman

Locations

1 EU/EEA country · 14 investigational sites

By country

Country	MS status	Planned subjects	Sites
Sweden	Ongoing, recruiting	420	14
Rest of world	—	0	—

Investigational sites

Sweden

14 sites · Ongoing, recruiting

Region Skane Helsingborg Hospital

Infektionskliniken, Charlotte Yhlens Gata 10, Helsingborgs Maria, Helsingborg

Sahlgrenska University Hospital-Vastra Gotalandsregionen

Infektionskliniken, Diagnosvagen 11, Harlanda, Gothenburg

Karolinska University Hospital

Infektionskliniken H7 infektion och Hud, Halsovagen, Flemingsberg, Huddinge

Region Skane Skanes Universitetssjukhus

Infektionskliniken, Hälsogatan 3, Entregatan 7, Lunds Allhelgonafors, Lund

Region Uppsala

Infektionskliniken, Storgatan 27, Uppsala Domkyrkofors., Uppsala

Region Blekinge

Infektionskliniken, Lasarettsvagen, 371 85, Karlskrona

Region Oerebro Laen

Infektionskliniken, Sodra Grev Rosengatan, 701 85, Orebro

Region Skane Kristianstad Central Hospital

Infektionskliniken, J A Hedlunds Vag 5, Kristianstads Heliga Trefaldighet, Kristianstad

Vasteras Central Hospital

Infektionskliniken, Centrallasarettet 1, Vasteras Badelunda, Vasteras

Region Vaesternorrland

Infektionskliniken, Lasarettsvagen 21, 856 43, Sundsvall

Region Stockholm

Infektionskliniken, Lindhagensgatan 98, Vastermalm, Stockholm

Soedra Aelvsborg Hospital Vaestra Goetalandsregionen

Infektionskliniken, Bramhultsvagen 53, Boras Gustav Adolf, Boras

NU Hospital Group-Vaestra Goetalandsregionen

Infektionskliniken, Larketorpsvagen, 461 85, Trollhattan