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

Phase 1

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

• Registration Number: EUCTR2017-003529-13-DK
• Lead Sponsor: Thomas Benfield

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-08
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 284

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 < 37,8 ?C (100 F) at randomization
• S. aureus negative follow-up blood culture obtained 48-120 hours after microbiological verified SAB.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 94
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 190

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 < 1,0 x 109/l)
• Untreated terminal cancer
• Chemotherapy within 30 days
• Corticosteroid treatment (> 20mg/day prednisone or the equivalent for >14 days) within the last 30 days.
• Ongoing treatment with immunosuppresive agents (ATC code L04A)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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