Oral versus Intravenous Antibiotics for Bone and Joint Infection

被引：600

作者：

Li, H. -K. ^{[1
,5
]}

Rombach, I. ^{[2
]}

Zambellas, R. ^{[2
]}

Walker, A. S. ^{[6
]}

McNally, M. A. ^{[1
]}

Atkins, B. L. ^{[1
]}

Lipsky, B. A. ^{[4
]}

Hughes, H. C. ^{[10
]}

Bose, D. ^{[11
]}

Kumin, M. ^{[3
]}

Scarborough, C. ^{[3
]}

Matthews, P. C. ^{[1
,3
]}

Brent, A. J. ^{[1
,3
]}

Lomas, J. ^{[1
]}

Gundle, R. ^{[1
]}

Rogers, M. ^{[1
]}

Taylor, A. ^{[1
]}

Angus, B. ^{[1
,3
]}

Byren, I. ^{[1
]}

Berendt, A. R. ^{[1
]}

Warren, S. ^{[7
,13
]}

Fitzgerald, F. E. ^{[13
]}

Mack, D. J. F. ^{[7
,13
]}

Hopkins, S. ^{[7
]}

Folb, J. ^{[14
]}

Reynolds, H. E. ^{[14
]}

Moore, E. ^{[15
]}

Marshall, J. ^{[15
]}

Jenkins, N. ^{[12
]}

Moran, C. E. ^{[12
]}

Woodhouse, A. F. ^{[12
]}

Stafford, S. ^{[12
]}

Seaton, R. A. ^{[16
]}

Vallance, C. ^{[16
]}

Hemsley, C. J. ^{[8
]}

Bisnauthsing, K. ^{[8
]}

Sandoe, J. A. T. ^{[18
]}

Aggarwal, I. ^{[19
]}

Ellis, S. C. ^{[20
]}

Bunn, D. J. ^{[20
]}

Sutherland, R. K. ^{[21
]}

Barlow, G. ^{[22
]}

Cooper, C. ^{[2
]}

Geue, C. ^{[17
]}

McMeekin, N. ^{[17
]}

Briggs, A. H. ^{[17
]}

Sendi, P. ^{[23
]}

Khatamzas, E. ^{[1
]}

Wangrangsimakul, T. ^{[1
]}

Wong, T. H. N. ^{[1
]}

机构：

[1] Oxford Univ Hosp NHS Fdn Trust, Oxford, England

[2] Univ Oxford, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, Oxford, England

[3] Univ Oxford, Dept Med, Oxford, England

[4] Univ Oxford, Div Med Sci, Oxford, England

[5] Imperial Coll London, Div Infect Dis, London, England

[6] UCL, Med Res Council Clin Trials Unit, London, England

[7] Royal Free London NHS Fdn Trust, London, England

[8] Guys & St Thomas NHS Fdn Trust, London, England

[9] Publ Hlth England, London, England

[10] Univ Wales Hosp, Cardiff, S Glam, Wales

[11] Univ Hosp Birmingham NHS Fdn Trust, Birmingham, W Midlands, England

[12] Heart England NHS Fdn Trust, Birmingham, W Midlands, England

[13] Royal Natl Orthopaed Hosp NHS Trust, Stanmore, Middx, England

[14] Royal Liverpool & Broadgreen Univ Hosp NHS Trust, Liverpool, Merseyside, England

[15] Cambridge Univ Hosp NHS Fdn Trust, Cambridge, England

[16] Queen Elizabeth Univ Hosp, NHS Greater Glasgow & Clyde, Glasgow, Lanark, Scotland

[17] Univ Glasgow, Hlth Econ & Hlth Technol Assessment, Glasgow, Lanark, Scotland

[18] Univ Leeds, Leeds Teaching Hosp NHS Trust, Leeds, W Yorkshire, England

[19] Ninewells Hosp, NHS Tayside, Dundee, Scotland

[20] Northumbria Healthcare NHS Fdn Trust, Northumberland, England

[21] Western Gen Hosp, NHS Lothian, Edinburgh, Midlothian, Scotland

[22] Hull & East Yorkshire Hosp NHS Trust, Kingston Upon Hull, N Humberside, England

[23] Univ Bern, Bern, Switzerland

[24] Univ Oxford, Clin Res Unit, Wellcome Trust, Ho Chi Minh City, Vietnam

[25] Kenya Med Res Inst KEMRI, Wellcome Trust Res Programme, Kilifi, Kenya

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2019年 / 380卷 / 05期

关键词：

OSTEOMYELITIS;

D O I：

10.1056/NEJMoa1710926

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND The management of complex orthopedic infections usually includes a prolonged course of intravenous antibiotic agents. We investigated whether oral antibiotic therapy is noninferior to intravenous antibiotic therapy for this indication. METHODS We enrolled adults who were being treated for bone or joint infection at 26 U.K. centers. Within 7 days after surgery (or, if the infection was being managed without surgery, within 7 days after the start of antibiotic treatment), participants were randomly assigned to receive either intravenous or oral antibiotics to complete the first 6 weeks of therapy. Follow-on oral antibiotics were permitted in both groups. The primary end point was definitive treatment failure within 1 year after randomization. In the analysis of the risk of the primary end point, the noninferiority margin was 7.5 percentage points. RESULTS Among the 1054 participants (527 in each group), end-point data were available for 1015 (96.3%). Treatment failure occurred in 74 of 506 participants (14.6%) in the intravenous group and 67 of 509 participants (13.2%) in the oral group. Missing end-point data (39 participants, 3.7%) were imputed. The intention-to-treat analysis showed a difference in the risk of definitive treatment failure (oral group vs. intravenous group) of -1.4 percentage points (90% confidence interval [CI], -4.9 to 2.2; 95% CI, -5.6 to 2.9), indicating noninferiority. Complete-case, per-protocol, and sensitivity analyses supported this result. The between-group difference in the incidence of serious adverse events was not significant (146 of 527 participants [27.7%] in the intravenous group and 138 of 527 [26.2%] in the oral group; P=0.58). Catheter complications, analyzed as a secondary end point, were more common in the intravenous group (9.4% vs. 1.0%). CONCLUSIONS Oral antibiotic therapy was noninferior to intravenous antibiotic therapy when used during the first 6 weeks for complex orthopedic infection, as assessed by treatment failure at 1 year.

引用

页码：425 / 436

页数：12

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