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Seven Versus Fourteen Days of Treatment in Uncomplicated Staphylococcus Aureus Bacteremia (SAB7)

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ClinicalTrials.gov Identifier: NCT03514446
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Benfield, Hvidovre University Hospital

Brief Summary:

Introduction: Staphylococcus aureus bacteremia (SAB) plays an important role in long-course antibiotic therapy. Current international guidelines recommend fourteen days of intravenous antibiotic treatment for SAB in order to minimize risks of secondary deep infections and complications. However, patients with simple SAB are known to have a low risk of complications. Reducing treatment length in uncomplicated SAB would reduce the total consumption of antibiotics, adverse events and duration of hospital admission. SAB7 seeks to determine if seven days of antibiotic treatment in patients with uncomplicated SAB is non-inferior to fourteen days of treatment.

Method: The study is designed as a randomized, non-blinded, non-inferiority interventional study. Primary measure of outcome will be failure to treatment or recurrence of SAB twelve weeks after termination of antibiotic treatment. As a measure of secondary outcome the prevalence of severe adverse effects will be evaluated, in particular secondary infection with Clostridium difficile, mortality as well as public health related costs. Patients identified with uncomplicated SAB, are randomized 1:1 in two parallel arms to seven or fourteen days of antimicrobial treatment, respectively. Endpoints will be tested with a statistical non-inferiority margin of 10%.

Conclusion: SAB 7 will determine if seven days of antibiotic treatment in patients with uncomplicated SAB is sufficient and safe, potentially modifying current treatment recommendations.


Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Bacteremia Drug: Antibiotic therapy duration for 7 days Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Seven and Fourteen Days of Antibiotic Treatment in Uncomplicated Staphylococcus Aureus Bacteremia: A Randomized, Non-blinded, Non-inferiority Interventional Study
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Antibiotic therapy duration for 7 days Drug: Antibiotic therapy duration for 7 days
Antibiotic therapy for seven days

No Intervention: Antibiotic therapy duration for 14 days



Primary Outcome Measures :
  1. 90-day survival without clinical or microbiological failure to treatment or relapse [ Time Frame: up to 90 days ]

Secondary Outcome Measures :
  1. Microbiologically failure to treatment [ Time Frame: less than 7 days after treatment termination ]
    Verified S. aureus infection of the same genotype as the initial infection

  2. Microbiologically relapse [ Time Frame: more than 7 days after treatment termination ]
    Verified S. aureus infection of the same genotype as the initial infection

  3. Clinical failure to treatment or relapse [ Time Frame: Up to day 90 ]
    Initiation of anti-staphylococcal therapy for more than 48 hours due to suspected recurrence.

  4. Mortality [ Time Frame: Days 14, 28, 90 and 180 ]
    All-cause mortality

  5. Severe adverse events [ Time Frame: Up to 26 weeks ]
    grade 3 or above adverse events

  6. Acute renal injury [ Time Frame: Up to 26 weeks ]
    A 1.5 fold increase in creatinine or a 25% decrease of the glomerular filtration rate (GFR)

  7. Clostridium difficile infection [ Time Frame: Up to 26 weeks ]
    Microbiologically verified C. difficile infection

  8. Multidrug-resistance organism [ Time Frame: Up to 26 weeks ]
    Microbiologically verified multidrug-resistance organism

  9. Health-associated costs [ Time Frame: Up to 26 weeks ]
    Public health related cost estimated from a general consideration of the expenses associated with hospitalization for SAB.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 < 37,5 degrees celsius at randomization
  • S. aureus negative follow-up blood culture obtained 48-96 hours after microbiological verified SAB.
  • Patients written consent obtained

Exclusion Criteria:

  • Persistence of S. aureus bacteremia before randomization (S. aureus positive follow-up blood culture obtained 48-96 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
  • Pacemaker or other intracardiac implant
  • Failure to remove a likely focus of infection, such as central venous catheter within 72 hours of the first positive blood culture.
  • Prosthetics in joints and bones or vascular grafts
  • Pneumonia or infection involving bone or joints
  • Previously bone/join infection
  • S. aureus infection within the last 90 days
  • Pregnancy or breastfeeding
  • Neutropenia (blood neutrophils < 1,0 x 109/l)
  • Untreated cancer
  • Chemotherapy within 90 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514446


Contacts
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Contact: Louise Thorlacius-Ussing, MD +45 26457710 louise.thorlacius-ussing@regionh.dk
Contact: Thomas Benfield, MD, DMSc Thomas.Lars.Benfield@regionh.dk

Locations
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Denmark
Hvidovre Hospital Recruiting
Hvidovre, Copenhagen, Denmark, 2650
Contact: Louise Ussing, MD    26457710    louise.thorlacius-ussing@regionh.dk   
Sponsors and Collaborators
Thomas Benfield

Additional Information:
Publications:

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Responsible Party: Thomas Benfield, Clinical Professor, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03514446     History of Changes
Other Study ID Numbers: H-17027414
2017-003529-13 ( EudraCT Number )
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents