Comparison of the effect of seven vs fourteen days of antibiotic treatment in patients with uncomplictaed Staphylococcus aureus bloodstream infections.

Efficacy of seven and fourteen days of antibiotic treatment in uncomplicated Staphylococcus aureus bacterermia: A randomized, non-blinded, non-inferiority interventional study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003529-13-DK

Enrollment

284

Registered

2017-09-08

Start date

2017-10-19

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Staphylococcus aureus bacteremia MedDRA version: 21.1 Level: LLT Classification code 10058887 Term: Staphylococcus aureus bacteremia System Organ Class: 10021881 - Infections and infestations

Interventions

Pharmaceutical Form: Infusion INN or Proposed INN: Piperacillin Other descriptive name: PIPERACILLIN SODIUM Concentration unit: g gram(s) Concentration type: range Concentration number: 2-4 INN or Pro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age > 18 years • Blood culture positive for staphylococcus aureus • Antibiotic treatment whit activity for S. aureus administrated within 12 hours of the first positive blood culture • Temperature =65 years) yes F.1.3.1 Number of subjects for this age range 190

Exclusion criteria

Exclusion criteria: • Persistence S. aureus bacteremia before randomization ( Staph aureus positive control blood culture obtained 48-120 hours of the first positive blood culture) • Polymicrobial infection • Antibiotic treatment with no antibacterial activity for 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, joins or foreign bodies. • Pneumonia requiring oxygen supply at randomization. • S. aureus infection within the last 90 days • Pregnancy or breastfeeding • Neutropenia (blood neutrophils 20mg/day prednisone or the equivalent for >14 days) within the last 30 days. • Ongoing treatment with immunosuppresive agents (ATC code L04A)

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine if seven days of antibiotic treatment in uncomplicated Staphylococcus aureus bacteremia is non-inferior to fourteen days of treatment.;Secondary Objective: To reduce the consumption of antibiotics, as well as shortened hospital admission and thereby potentially decrease the risk of adverse events, antibiotic –associated infections and microbial resistance development.;Primary end point(s): All-cause mortality, microbiological or clinical failure to treatment or relapse ;Timepoint(s) of evaluation of this end point: 90 days	—

Measure

Time frame

Main Objective: To determine if seven days of antibiotic treatment in uncomplicated Staphylococcus aureus bacteremia is non-inferior to fourteen days of treatment.;Secondary Objective: To reduce the consumption of antibiotics, as well as shortened hospital admission and thereby potentially decrease the risk of adverse events, antibiotic –associated infections and microbial resistance development.;Primary end point(s): All-cause mortality, microbiological or clinical failure to treatment or relapse ;Timepoint(s) of evaluation of this end point: 90 days

—

Secondary

Measure	Time frame
Secondary end point(s): - All-cause mortality days 14, 28, 90 and 180 - Microbiological failure to treatment - Microbiological relapse - Clinical failure to treatment - Severe adverse events grade =3 - Acute renal injury - Clostridium difficile infection - Multidrug-resistance organism - Health-associated costs associated the treatment lengths - Desirability of outcome ranking (DOOR) - Hospital admissions during follow up ;Timepoint(s) of evaluation of this end point: Evalutation of the presence of severe adverse events within 24 weeks of the diagnosis	—

Measure

Time frame

Secondary end point(s): - All-cause mortality days 14, 28, 90 and 180 - Microbiological failure to treatment - Microbiological relapse - Clinical failure to treatment - Severe adverse events grade =3 - Acute renal injury - Clostridium difficile infection - Multidrug-resistance organism - Health-associated costs associated the treatment lengths - Desirability of outcome ranking (DOOR) - Hospital admissions during follow up ;Timepoint(s) of evaluation of this end point: Evalutation of the presence of severe adverse events within 24 weeks of the diagnosis

—

Countries

Denmark

Contacts

Public ContactLouise Thorlacius-Ussing

Thomas Benfield

louise.thorlacius-ussing@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026