Imperial College London

ProfessorGrahamCooke

Faculty of MedicineDepartment of Infectious Disease

Vice Dean (Research); Professor of Infectious Diseases
 
 
 
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Contact

 

g.cooke

 
 
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Location

 

Infectious Diseases SectionMedical SchoolSt Mary's Campus

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Summary

 

Publications

Citation

BibTex format

@article{Scarborough:2019:10.3310/hta23380,
author = {Scarborough, M and Li, HK and Rombach, I and Zambellas, R and Walker, AS and McNally, M and Atkins, B and Kumin, M and Lipsky, BA and Hughes, H and Bose, D and Warren, S and Mack, D and Folb, J and Moore, E and Jenkins, N and Hopkins, S and Seaton, RA and Hemsley, C and Sandoe, J and Aggarwal, I and Ellis, S and Sutherland, R and Geue, C and McMeekin, N and Scarburough, C and Paul, J and Cooke, G and Bostock, J and Khatamzas, E and Wong, N and Brent, A and Lomas, J and Matthews, P and Wangrangsimakul, T and Gundle, R and Rogers, M and Taylor, A and Thwaites, GE and Bejon, P},
doi = {10.3310/hta23380},
journal = {Health Technology Assessment},
pages = {1--94},
title = {Oral versus intravenous antibiotics for bone and joint infections: the OVIVA non-inferiority RCT},
url = {http://dx.doi.org/10.3310/hta23380},
volume = {23},
year = {2019}
}

RIS format (EndNote, RefMan)

TY  - JOUR
AB - BackgroundManagement of bone and joint infection commonly includes 4–6 weeks of intravenous (IV) antibiotics, but there is little evidence to suggest that oral (PO) therapy results in worse outcomes.ObjectiveTo determine whether or not PO antibiotics are non-inferior to IV antibiotics in treating bone and joint infection.DesignParallel-group, randomised (1 : 1), open-label, non-inferiority trial. The non-inferiority margin was 7.5%.SettingTwenty-six NHS hospitals.ParticipantsAdults with a clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least 6 weeks of antibiotics, and who had received ≤ 7 days of IV therapy from definitive surgery (or start of planned curative treatment in patients managed non-operatively).InterventionsParticipants were centrally computer-randomised to PO or IV antibiotics to complete the first 6 weeks of therapy. Follow-on PO therapy was permitted in either arm.Main outcome measureThe primary outcome was the proportion of participants experiencing treatment failure within 1 year. An associated cost-effectiveness evaluation assessed health resource use and quality-of-life data.ResultsOut of 1054 participants (527 in each arm), end-point data were available for 1015 (96.30%) participants. Treatment failure was identified in 141 out of 1015 (13.89%) participants: 74 out of 506 (14.62%) and 67 out of 509 (13.16%) of those participants randomised to IV and PO therapy, respectively. In the intention-to-treat analysis, using multiple imputation to include all participants, the imputed risk difference between PO and IV therapy for definitive treatment failure was –1.38% (90% confidence interval –4.94% to 2.19%), thus meeting the non-inferiority criterion. A complete-case analysis, a per-protocol analysis and sensitivity analyses for missing data each confirmed this result. With the exception of IV catheter complications [49/523 (9.37%) in the IV arm v
AU - Scarborough,M
AU - Li,HK
AU - Rombach,I
AU - Zambellas,R
AU - Walker,AS
AU - McNally,M
AU - Atkins,B
AU - Kumin,M
AU - Lipsky,BA
AU - Hughes,H
AU - Bose,D
AU - Warren,S
AU - Mack,D
AU - Folb,J
AU - Moore,E
AU - Jenkins,N
AU - Hopkins,S
AU - Seaton,RA
AU - Hemsley,C
AU - Sandoe,J
AU - Aggarwal,I
AU - Ellis,S
AU - Sutherland,R
AU - Geue,C
AU - McMeekin,N
AU - Scarburough,C
AU - Paul,J
AU - Cooke,G
AU - Bostock,J
AU - Khatamzas,E
AU - Wong,N
AU - Brent,A
AU - Lomas,J
AU - Matthews,P
AU - Wangrangsimakul,T
AU - Gundle,R
AU - Rogers,M
AU - Taylor,A
AU - Thwaites,GE
AU - Bejon,P
DO - 10.3310/hta23380
EP - 94
PY - 2019///
SN - 1366-5278
SP - 1
TI - Oral versus intravenous antibiotics for bone and joint infections: the OVIVA non-inferiority RCT
T2 - Health Technology Assessment
UR - http://dx.doi.org/10.3310/hta23380
UR - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000478571600001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR - http://hdl.handle.net/10044/1/73991
VL - 23
ER -