Authorised Therapeutic use (Phase IV) Staphylococcus aureus bacteremia

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

EU CTIS ID: 2024-519186-21-01

What this study is testing

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.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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

You likely can't join if

  • Persistence of S. aureus bacteremia before randomization (S. aureus positive follow-up blood culture obtained 48-120 hours of the first positive blood culture)
  • 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • Persistence of S. aureus bacteremia before randomization (S. aureus positive follow-up blood culture obtained 48-120 hours of the first positive blood culture)
  • 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)
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Brazil

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Brazil. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.