Seven Versus Fourteen Days of Treatment in Uncomplicated Staphylococcus Aureus Bacteremia
NCT ID: NCT03514446
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
284 participants
INTERVENTIONAL
2018-06-01
2021-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Antibiotic therapy duration for 7 days
Antibiotic therapy duration for 7 days
Antibiotic therapy for seven days
Antibiotic therapy duration for 14 days
No interventions assigned to this group
Interventions
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Antibiotic therapy duration for 7 days
Antibiotic therapy for seven days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Thomas Benfield
OTHER
Responsible Party
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Thomas Benfield
Clinical Professor
Locations
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Hvidovre Hospital
Hvidovre, Copenhagen, Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Banaei N, Anikst V, Schroeder LF. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015 Jun 11;372(24):2368-9. doi: 10.1056/NEJMc1505190. No abstract available.
Kaasch AJ, Fatkenheuer G, Prinz-Langenohl R, Paulus U, Hellmich M, Weiss V, Jung N, Rieg S, Kern WV, Seifert H; SABATO trial group (with linked authorship to the individuals in the Acknowledgements section). Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO): study protocol for a randomized controlled trial. Trials. 2015 Oct 9;16:450. doi: 10.1186/s13063-015-0973-x.
Thwaites GE, Edgeworth JD, Gkrania-Klotsas E, Kirby A, Tilley R, Torok ME, Walker S, Wertheim HF, Wilson P, Llewelyn MJ; UK Clinical Infection Research Group. Clinical management of Staphylococcus aureus bacteraemia. Lancet Infect Dis. 2011 Mar;11(3):208-22. doi: 10.1016/S1473-3099(10)70285-1.
Blyth CC, Darragh H, Whelan A, O'Shea JP, Beaman MH, McCarthy JS. Evaluation of clinical guidelines for the management of Staphylococcus aureus bacteraemia. Intern Med J. 2002 May-Jun;32(5-6):224-32. doi: 10.1046/j.1445-5994.2001.00205.x.
Benfield T, Espersen F, Frimodt-Moller N, Jensen AG, Larsen AR, Pallesen LV, Skov R, Westh H, Skinhoj P. Increasing incidence but decreasing in-hospital mortality of adult Staphylococcus aureus bacteraemia between 1981 and 2000. Clin Microbiol Infect. 2007 Mar;13(3):257-63. doi: 10.1111/j.1469-0691.2006.01589.x.
Zeylemaker MM, Jaspers CA, van Kraaij MG, Visser MR, Hoepelman IM. Long-term infectious complications and their relation to treatment duration in catheter-related Staphylococcus aureus bacteremia. Eur J Clin Microbiol Infect Dis. 2001 Jun;20(6):380-4. doi: 10.1007/pl00011278.
Raad II, Sabbagh MF. Optimal duration of therapy for catheter-related Staphylococcus aureus bacteremia: a study of 55 cases and review. Clin Infect Dis. 1992 Jan;14(1):75-82. doi: 10.1093/clinids/14.1.75.
Fowler VG Jr, Sanders LL, Sexton DJ, Kong L, Marr KA, Gopal AK, Gottlieb G, McClelland RS, Corey GR. Outcome of Staphylococcus aureus bacteremia according to compliance with recommendations of infectious diseases specialists: experience with 244 patients. Clin Infect Dis. 1998 Sep;27(3):478-86. doi: 10.1086/514686.
Mylotte JM, McDermott C, Spooner JA. Prospective study of 114 consecutive episodes of Staphylococcus aureus bacteremia. Rev Infect Dis. 1987 Sep-Oct;9(5):891-907. doi: 10.1093/clinids/9.5.891.
Ehni WF, Reller LB. Short-course therapy for catheter-associated Staphylococcus aureus bacteremia. Arch Intern Med. 1989 Mar;149(3):533-6.
Larsen AR, Stegger M, Sorum M. spa typing directly from a mecA, spa and pvl multiplex PCR assay-a cost-effective improvement for methicillin-resistant Staphylococcus aureus surveillance. Clin Microbiol Infect. 2008 Jun;14(6):611-4. doi: 10.1111/j.1469-0691.2008.01995.x. Epub 2008 Apr 3.
Mejer N, Westh H, Schonheyder HC, Jensen AG, Larsen AR, Skov R, Benfield T; Danish Staphylococcal Bacteraemia Study Group. Stable incidence and continued improvement in short term mortality of Staphylococcus aureus bacteraemia between 1995 and 2008. BMC Infect Dis. 2012 Oct 17;12:260. doi: 10.1186/1471-2334-12-260.
Mylotte JM, McDermott C. Staphylococcus aureus bacteremia caused by infected intravenous catheters. Am J Infect Control. 1987 Feb;15(1):1-6. doi: 10.1016/0196-6553(87)90069-1.
Iannini PB, Crossley K. Therapy of Staphylococcus aureus bacteremia associated with a removable focus of infection. Ann Intern Med. 1976 May;84(5):558-60. doi: 10.7326/0003-4819-84-5-558.
Jensen AG, Wachmann CH, Espersen F, Scheibel J, Skinhoj P, Frimodt-Moller N. Treatment and outcome of Staphylococcus aureus bacteremia: a prospective study of 278 cases. Arch Intern Med. 2002 Jan 14;162(1):25-32. doi: 10.1001/archinte.162.1.25.
Related Links
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Other Identifiers
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2017-003529-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
H-17027414
Identifier Type: -
Identifier Source: org_study_id
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