Efficacy of seven and fourteen days of antibiotic treatment in uncomplicated Staphylococcus aureus bacteremia: A randomized, non-blinded, non-inferiority interventional study (SAB 7)

Start 30 Jan 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 8 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Ongoing, recruiting

Participants planned 284

Countries 1

Sites 8

Staphylococcus aureus bacteremia

To compare 7 and 14 days of antibiotic treatment in patients with uncomplicated SAB in terms of mortality and the prevalence of microbiological and clinical failure to treat and recurrence within 90 days of diagnosis.

Key facts

Sponsor: Hvidovre Hospital
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: 30 Jan 2025 → ongoing
Decision date (initial): 2025-01-30
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2024-519186-21-01
EudraCT number: 2017-003529-13
ClinicalTrials.gov: NCT03514446

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Secondary objectives 1

To explore the possibility of reducing the consumption of antibiotics, as well as shortened hospital admission, and thereby potentially decrease the risk of adverse events and microbial resistance development.

Conditions and MedDRA coding

Staphylococcus aureus bacteremia

Regulatory references

Plan to share IPD: Yes

EU CT number	Title	Sponsor
2024-519186-21-00	Efficacy of seven and fourteen days of antibiotic treatment in uncomplicated Staphylococcus aureus bacteremia: A randomized, non-blinded, non-inferiority interventional study	Hvidovre Hospital

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

Age ≥ 18 years
Blood culture positive for Staphylococcus aureus
Antibiotic treatment with antimicrobial activity to S. aureus administrated within 12 hours of the first positive blood culture
Temperature < 37,8 ᵒC (100°F) at randomization
S. aureus negative follow-up blood culture obtained 48-120 hours after microbiological verified SAB

Exclusion criteria 15

Persistence of S. aureus bacteremia before randomization (S. aureus positive follow-up blood culture obtained 48-120 hours of the first positive blood culture)
Polymicrobial infection
Antibiotic treatment whit no antimicrobial activity to S. aureus administrated more than 12 hours of the first positive blood culture
Endocarditis or other intracardiac infection demonstrated with transthoracic or transesophageal echocardiography
Previous history of endocarditis or pacemaker/AICD infection
Failure to remove a likely focus of infection, such as central venous catheter within 72 hours of the first positive blood culture
Infection involving bone, joints or foreign bodies
Pneumonia requiring oxygen supply at randomization
S. aureus infection within the last 90 days
Pregnancy or breastfeeding
Neutropenia (blood neutrophils < 1,0 x 109/l)
Untreated terminal cancer
Chemotherapy within 30 days
Corticosteroid treatment (> 20 mg/day prednisone or the equivalent for > 14 days) within the last 30 days
Ongoing treatment with immunosuppressive agents (ATC code L04A)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

90-day survival without clinical or microbiological failure to treatment or relapse in patients treated with 7 days versus 14 days of antibiotic therapy

Secondary endpoints 11

All-cause mortality days 14, 28, 90 and 180
Microbiological failure to treatment
Microbiological relapse
Clinical failure to treatment
Severe adverse events grade ≥3
Severe adverse events grade ≥3
Clostridium difficile infection
Multidrug-resistance organism
Health-associated costs associated the treatment lengths
Desirability of outcome ranking (DOOR)
Hospital admissions during follow up

Investigational products

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

Test 41

Clarithromycin ”Alternova”, pulver til infusionsvæske, opløsning

PRD1651619 · Product

Active substance: Clarithromycin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 500 mg milligram(s)
Max total dose: 7000 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01FA09 — CLARITHROMYCIN
Marketing authorisation: 53353
MA holder: ALTERNOVA A/S
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Benzylpenicillin ”Panpharma”, pulver til injektions- og infusionsvæske, opløsning

PRD2715063 · Product

Active substance: Benzylpenicillin Sodium
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 4 million IU million international units
Max total dose: 56 million IU million international units
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CE01 — BENZYLPENICILLIN
Marketing authorisation: 32499
MA holder: PANPHARMA
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Benzylpenicillin ”Panpharma”, pulver til injektions- og infusionsvæske, opløsning

PRD2715064 · Product

Active substance: Benzylpenicillin Sodium
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 4 million IU million international units
Max total dose: 56 million IU million international units
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CE01 — BENZYLPENICILLIN
Marketing authorisation: 32507
MA holder: PANPHARMA
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Benzylpenicillin ”Panpharma”, pulver til injektions- og infusionsvæske, opløsning

PRD2715065 · Product

Active substance: Benzylpenicillin Sodium
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 4 million IU million international units
Max total dose: 56 million IU million international units
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CE01 — BENZYLPENICILLIN
Marketing authorisation: 32508
MA holder: PANPHARMA
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Linezolid Fresenius Kabi

PRD2479887 · Product

Active substance: Linezolid
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 1200 mg milligram(s)
Max total dose: 16800 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01XX08 — LINEZOLID
Marketing authorisation: 53133
MA holder: FRESENIUS KABI AB
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Meropenem Fresenius Kabi

PRD2054440 · Product

Active substance: Meropenem Trihydrate
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 2 g gram(s)
Max total dose: 28 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01DH02 — MEROPENEM
Marketing authorisation: 45320
MA holder: FRESENIUS KABI AB
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Meropenem Fresenius Kabi

PRD2054441 · Product

Active substance: Meropenem Trihydrate
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 2 g gram(s)
Max total dose: 28 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01DH02 — MEROPENEM
Marketing authorisation: 45319
MA holder: FRESENIUS KABI AB
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bactocin, pulver til infusionsvæske, opløsning

PRD2566642 · Product

Active substance: Vancomycin Hydrochloride
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 2 g gram(s)
Max total dose: 28 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01XA01 — VANCOMYCIN
Marketing authorisation: 46552
MA holder: MIP PHARMA GMBH
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bactocin, pulver til infusionsvæske, opløsning

PRD2566717 · Product

Active substance: Vancomycin Hydrochloride
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 2 g gram(s)
Max total dose: 28 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01XA01 — VANCOMYCIN
Marketing authorisation: 46553
MA holder: MIP PHARMA GMBH
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Gentamicin ”B. Braun”, infusionsvæske, opløsning

PRD567949 · Product

Active substance: Gentamicin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 5 mg/Kg milligram(s)/kilogram
Max total dose: 70 mg/Kg milligram(s)/kilogram
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01GB03 — GENTAMICIN
Marketing authorisation: 40199
MA holder: B.BRAUN MELSUNGEN AG
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Gentamicin ”B. Braun”, infusionsvæske, opløsning

PRD567954 · Product

Active substance: Gentamicin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 5 mg/Kg milligram(s)/kilogram
Max total dose: 70 mg/Kg milligram(s)/kilogram
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01GB03 — GENTAMICIN
Marketing authorisation: 40200
MA holder: B.BRAUN MELSUNGEN AG
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Moxifloxacin "Accord", filmovertrukne tabletter

PRD7852473 · Product

Active substance: Moxifloxacin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 400 mg milligram(s)
Max total dose: 5600 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01MA14 — MOXIFLOXACIN
Marketing authorisation: 62092
MA holder: ACCORD HEALTHCARE B.V.
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Flucloxacillin "Orion", filmovertrukne tabletter

PRD4315220 · Product

Active substance: Flucloxacillin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 4 g gram(s)
Max total dose: 56 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CF05 — FLUCLOXACILLIN
Marketing authorisation: 56616
MA holder: ORION CORPORATION
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Flucloxacillin ”Orion”

PRD524506 · Product

Active substance: Flucloxacillin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 4 g gram(s)
Max total dose: 56 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CF05 — FLUCLOXACILLIN
Marketing authorisation: 46679
MA holder: ORION CORPORATION
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Flucloxacillin ”Orion”

PRD524502 · Product

Active substance: Flucloxacillin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 4 g gram(s)
Max total dose: 56 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CF05 — FLUCLOXACILLIN
Marketing authorisation: 46678
MA holder: ORION CORPORATION
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Piperacillin/Tazobactam "Sandoz"

PRD791526 · Product

Active substance: Piperacillin
Pharmaceutical form: POWDER FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 16 g gram(s)
Max total dose: 224 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
Marketing authorisation: 39467
MA holder: SANDOZ A/S
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Piperacillin/Tazobactam ”Sandoz”, pulver til infusionsvæske, opløsning

PRD894455 · Product

Active substance: Piperacillin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 16 g gram(s)
Max total dose: 224 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
Marketing authorisation: 39468
MA holder: SANDOZ A/S
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ertapenem Fresenius Kabi

PRD5082241 · Product

Active substance: Ertapenem Sodium
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 1 g gram(s)
Max total dose: 14 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01DH03 — -
Marketing authorisation: 57307
MA holder: FRESENIUS KABI AB
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Daptomycin "Accord Healthcare", pulver til injektions-/infusionsvæske, opløsning

PRD10575633 · Product

Active substance: Daptomycin
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 10 mg/Kg milligram(s)/kilogram
Max total dose: 240 mg/Kg milligram(s)/kilogram
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01XX09 — -
Marketing authorisation: 66991
MA holder: ACCORD HEALTHCARE B.V.
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Daptomycin "Accord Healthcare", pulver til injektions-/infusionsvæske, opløsning

PRD10575632 · Product

Active substance: Daptomycin
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 10 mg/Kg milligram(s)/kilogram
Max total dose: 240 mg/Kg milligram(s)/kilogram
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01XX09 — -
Marketing authorisation: 66990
MA holder: ACCORD HEALTHCARE B.V.
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Clarithromycin "Accord", filmovertrukne tabletter

PRD4900058 · Product

Active substance: Clarithromycin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 500 mg milligram(s)
Max total dose: 7000 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01FA09 — CLARITHROMYCIN
Marketing authorisation: 57354
MA holder: ACCORD HEALTHCARE B.V.
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Clarithromycin "Accord", filmovertrukne tabletter

PRD4900059 · Product

Active substance: Clarithromycin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 500 mg milligram(s)
Max total dose: 7000 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01FA09 — CLARITHROMYCIN
Marketing authorisation: 57353
MA holder: ACCORD HEALTHCARE B.V.
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cefotaxim "MIP", pulver til injektions-/infusionsvæske, opløsning

PRD11735224 · Product

Active substance: Cefotaxime
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 2 g gram(s)
Max total dose: 28 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01DD01 — -
Marketing authorisation: 50359
MA holder: MIP PHARMA GMBH
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cefotaxim "MIP", pulver til injektions-/infusionsvæske, opløsning

PRD11735218 · Product

Active substance: Cefotaxime
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 2 g gram(s)
Max total dose: 28 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01DD01 — -
Marketing authorisation: 50358
MA holder: MIP PHARMA GMBH
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Moxifloxacin Fresenius Kabi

PRD2058208 · Product

Active substance: Moxifloxacin Hydrochloride
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 400 mg milligram(s)
Max total dose: 5600 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01MA14 — MOXIFLOXACIN
Marketing authorisation: 51967
MA holder: FRESENIUS KABI AB
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sulfametoxazol med trimetoprim SAD, tabletter

PRD351283 · Product

Active substance: Sulfamethoxazole
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 1600 mg milligram(s)
Max total dose: 22400 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
Marketing authorisation: 16511
MA holder: AMGROS I/S
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Levofloxacin "Macure"

PRD11115277 · Product

Active substance: Levofloxacin
Pharmaceutical form: FILM COATED TABLET
Route of administration: ORAL
Max daily dose: 1000 mg milligram(s)
Max total dose: 14000 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01MA12 — LEVOFLOXACIN
Marketing authorisation: 66906
MA holder: MACURE PHARMA APS
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Amikacin "Macure", injektionsvæske, opløsning

PRD8263048 · Product

Active substance: Amikacin
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 15 mg/Kg milligram(s)/kilogram
Max total dose: 360 mg/Kg milligram(s)/kilogram
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01GB06 — AMIKACIN
Marketing authorisation: 62523
MA holder: MACURE PHARMA APS
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cloxacillin "Stragen", pulver til injektions-/infusionsvæske, opløsning

PRD9365957 · Product

Active substance: Cloxacillin Sodium
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 4 g gram(s)
Max total dose: 56 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CF02 — CLOXACILLIN
Marketing authorisation: 66530
MA holder: STRAGEN NORDIC A/S
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Linezolid "Teva", filmovertrukne tabletter

PRD3065085 · Product

Active substance: Linezolid
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 1200 mg milligram(s)
Max total dose: 16800 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01XX08 — LINEZOLID
Marketing authorisation: 53077
MA holder: TEVA B.V
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Clindamycin ”Alternova”, hårde kapsler

PRD11494965 · Product

Active substance: Clindamycin
Substance synonyms: CLINDAMYCINUM
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 1800 mg milligram(s)
Max total dose: 25200 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01FF01 — CLINDAMYCIN
Marketing authorisation: 37826
MA holder: ALTERNOVA A/S
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Clindamycin ”Alternova”, hårde kapsler

PRD11494622 · Product

Active substance: Clindamycin
Substance synonyms: CLINDAMYCINUM
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 1800 mg milligram(s)
Max total dose: 25200 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01FF01 — CLINDAMYCIN
Marketing authorisation: 37825
MA holder: ALTERNOVA A/S
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Primcillin, filmovertrukne tabletter 800 mg

PRD11564664 · Product

Active substance: Phenoxymethylpenicillin Potassium
Substance synonyms: PENICILLIN V POTASSIUM
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 3200 mg milligram(s)
Max total dose: 44800 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CE02 — PHENOXYMETHYLPENICILLIN
Marketing authorisation: 9024
MA holder: VIATRIS APS
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Primcillin, filmovertrukne tabletter 400 mg

PRD11564573 · Product

Active substance: Phenoxymethylpenicillin Potassium
Substance synonyms: PENICILLIN V POTASSIUM
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 3200 mg milligram(s)
Max total dose: 44800 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CE02 — PHENOXYMETHYLPENICILLIN
Marketing authorisation: 9022
MA holder: VIATRIS APS
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dicloxacillin "Alternova", hårde kapsler

PRD11592388 · Product

Active substance: Dicloxacillin
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 4 g gram(s)
Max total dose: 56 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CF01 — DICLOXACILLIN
Marketing authorisation: 53049
MA holder: ALTERNOVA A/S
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dicloxacillin "Alternova", hårde kapsler

PRD11592385 · Product

Active substance: Dicloxacillin
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 4 g gram(s)
Max total dose: 56 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CF01 — DICLOXACILLIN
Marketing authorisation: 53048
MA holder: ALTERNOVA A/S
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Clindamycin "Abcur", injektions-/infusionsvæske, opløsning

PRD10102332 · Product

Active substance: Clindamycin
Substance synonyms: CLINDAMYCINUM
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 1800 mg milligram(s)
Max total dose: 25200 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01FF01 — CLINDAMYCIN
Marketing authorisation: 65165
MA holder: ABCUR AB
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ceftriaxon "Kalceks", pulver til injektions-/infusionsvæske, opløsning

PRD10146637 · Product

Active substance: Ceftriaxone
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 2 g gram(s)
Max total dose: 28 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01DD04 — -
Marketing authorisation: 66639
MA holder: KALCEKS
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ceftriaxon "Kalceks", pulver til injektions-/infusionsvæske, opløsning

PRD10146636 · Product

Active substance: Ceftriaxone
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 2 g gram(s)
Max total dose: 28 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01DD04 — -
Marketing authorisation: 66638
MA holder: KALCEKS
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cefuroxim Fresenius Kabi

PRD1163275 · Product

Active substance: Cefuroxime Sodium
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 6000 mg milligram(s)
Max total dose: 84000 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01DC02 — -
Marketing authorisation: 40967
MA holder: FRESENIUS KABI AB
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cefuroxim Fresenius Kabi

PRD1163276 · Product

Active substance: Cefuroxime Sodium
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 6000 mg milligram(s)
Max total dose: 84000 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01DC02 — -
Marketing authorisation: 40966
MA holder: FRESENIUS KABI AB
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hvidovre Hospital

Sponsor organisation: Hvidovre Hospital
Address: Kettegaard Alle 30
City: Hvidovre
Postcode: 2650
Country: Denmark

Scientific contact point

Organisation: Hvidovre Hospital
Contact name: Thomas Benfield

Public contact point

Organisation: Hvidovre Hospital
Contact name: Thomas Benfield

Third parties 1

Organisation	City, country	Duties
Frederiksberg Hospital ORG-100028217	Frederiksberg, Denmark	On site monitoring

Locations

1 EU/EEA country · 8 investigational sites

By country

Country	MS status	Planned subjects	Sites
Denmark	Ongoing, recruiting	264	8
Rest of world Brazil	—	20	—

Investigational sites

Denmark

8 sites · Ongoing, recruiting

Hillerod Hospital

Department of respiratory medicine, Dyrehavevej 29, 3400, Hilleroed

Sygehus Sønderjylland, Aabenraa

Department of Emergency Medicine, Kresten Philipsens Vej 15, 6200, Aabenraa

Herlev Hospital

Department of Infectious Diseases, Borgmester Ib Juuls Vej 1, 2730, Herlev

Odense University Hospital

Department of Infectious Diseases, Kloevervaenget 47, 5000, Odense C

Hvidovre Hospital

Department, Kettegaard Alle 30, 2650, Hvidovre

Gentofte Hospital

Department of Infectious Diseases, Kildegaardsvej 28, 2900, Hellerup

Bispebjerg Hospital

Department of respiratory medicine and infectious diseases, Bispebjerg Hospital, Bispebjerg Bakke, Copenhagen

Kolding Hospital

Department of Infectious Diseases, Sygehusvej 24, 6000, Kolding

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Denmark	2025-01-30		2025-02-10

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 29 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	Protocol	10
Recruitment arrangements (for publication)	Recruitment arrangements	1
Subject information and informed consent form (for publication)	informed consent	1
Subject information and informed consent form (for publication)	subject information	1
Summary of Product Characteristics (SmPC) (for publication)	Amikacin Macure SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Bactocin SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Benzylpenicillin Panpharma SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Cefotaxim MIP SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Ceftriaxon Kalceks SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Cefuroxim Fresenius Kabi SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Clarithromycin Accord SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Clindamycin Abcur SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Clindamycin Alternova SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Clindamycin Alternova SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Cloxacillin Stragen SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Daptomycin Accord Healthcare SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Dicloxacillin Alternova SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Ertapenem Fresenius Kabi SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Flucloxacillin Orion SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Gentamicin B Braun SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Levofloxacin Macure SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Linezolid Fresenius Kabi SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Linezolid Teva SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Meropenem Fresenius Kabi SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Moxifloxacin Accord SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Moxifloxacin Fresenius Kabi SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Piperacillin-Tazobactam Sandoz SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Primcillin SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Sulfametoxazol med trimetoprim SAD SmPC	1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-01-16	Denmark	Acceptable 2025-01-30	2025-01-30
2	SUBSTANTIAL MODIFICATION	SM-2	2025-10-09	Denmark	Acceptable 2025-11-17	2025-11-17

Efficacy of seven and fourteen days of antibiotic treatment in uncomplicated Staphylococcus aureus bacteremia: A randomized, non-blinded, non-inferiority interventional study (SAB 7)

Overview

Key facts

External identifiers

Trial design

Main objective

Secondary objectives 1

Conditions and MedDRA coding

Regulatory references

Eligibility criteria

Inclusion criteria 5

Exclusion criteria 15

Endpoints

Primary endpoints 1

Secondary endpoints 11

Investigational products

Test 41

Sponsors and contacts

Hvidovre Hospital

Scientific contact point

Public contact point

Third parties 1

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 29 files

Application history

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