Seven Versus Fourteen Days of Treatment in Uncomplicated Staphylococcus Aureus Bacteremia (SAB7)
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| ClinicalTrials.gov Identifier: NCT03514446 |
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Recruitment Status :
Recruiting
First Posted : May 2, 2018
Last Update Posted : October 19, 2020
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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 |
| 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 |
| 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 |
- 90-day survival without clinical or microbiological failure to treatment or relapse [ Time Frame: up to 90 days ]
- 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
- Microbiologically relapse [ Time Frame: more than 7 days after treatment termination ]Verified S. aureus infection of the same genotype as the initial infection
- 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.
- Mortality [ Time Frame: Days 14, 28, 90 and 180 ]All-cause mortality
- Severe adverse events [ Time Frame: Up to 26 weeks ]grade 3 or above adverse events
- 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)
- Clostridium difficile infection [ Time Frame: Up to 26 weeks ]Microbiologically verified C. difficile infection
- Multidrug-resistance organism [ Time Frame: Up to 26 weeks ]Microbiologically verified multidrug-resistance organism
- 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 |
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.
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
| Contact: Louise Thorlacius-Ussing, MD | +45 26457710 | louise.thorlacius-ussing@regionh.dk | |
| Contact: Thomas Benfield, MD, DMSc | Thomas.Lars.Benfield@regionh.dk |
| Denmark | |
| Hvidovre Hospital | Recruiting |
| Hvidovre, Copenhagen, Denmark, 2650 | |
| Contact: Louise Ussing, MD 26457710 louise.thorlacius-ussing@regionh.dk | |
Publications:
| Responsible Party: | Thomas Benfield, Clinical Professor, Hvidovre University Hospital |
| ClinicalTrials.gov Identifier: | NCT03514446 |
| Other Study ID Numbers: |
H-17027414 2017-003529-13 ( EudraCT Number ) |
| First Posted: | May 2, 2018 Key Record Dates |
| Last Update Posted: | October 19, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
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Staphylococcal Infections Bacteremia Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections |
Sepsis Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Anti-Bacterial Agents Anti-Infective Agents |