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Adjunctive rifampicin for Staphylococcus aureus bacteraemia (ARREST): a multicentre, randomised, double-blind, placebo-controlled trial

Adjunctive rifampicin for Staphylococcus aureus bacteraemia (ARREST): a multicentre, randomised, double-blind, placebo-controlled trial
Adjunctive rifampicin for Staphylococcus aureus bacteraemia (ARREST): a multicentre, randomised, double-blind, placebo-controlled trial
BACKGROUND:

Staphylococcus aureus bacteraemia is a common cause of severe community-acquired and hospital-acquired infection worldwide. We tested the hypothesis that adjunctive rifampicin would reduce bacteriologically confirmed treatment failure or disease recurrence, or death, by enhancing early S aureus killing, sterilising infected foci and blood faster, and reducing risks of dissemination and metastatic infection.

METHODS:

In this multicentre, randomised, double-blind, placebo-controlled trial, adults (≥18 years) with S aureus bacteraemia who had received ≤96 h of active antibiotic therapy were recruited from 29 UK hospitals. Patients were randomly assigned (1:1) via a computer-generated sequential randomisation list to receive 2 weeks of adjunctive rifampicin (600 mg or 900 mg per day according to weight, oral or intravenous) versus identical placebo, together with standard antibiotic therapy. Randomisation was stratified by centre. Patients, investigators, and those caring for the patients were masked to group allocation. The primary outcome was time to bacteriologically confirmed treatment failure or disease recurrence, or death (all-cause), from randomisation to 12 weeks, adjudicated by an independent review committee masked to the treatment. Analysis was intention to treat. This trial was registered, number ISRCTN37666216, and is closed to new participants.

FINDINGS:

Between Dec 10, 2012, and Oct 25, 2016, 758 eligible participants were randomly assigned: 370 to rifampicin and 388 to placebo. 485 (64%) participants had community-acquired S aureus infections, and 132 (17%) had nosocomial S aureus infections. 47 (6%) had meticillin-resistant infections. 301 (40%) participants had an initial deep infection focus. Standard antibiotics were given for 29 (IQR 18-45) days; 619 (82%) participants received flucloxacillin. By week 12, 62 (17%) of participants who received rifampicin versus 71 (18%) who received placebo experienced treatment failure or disease recurrence, or died (absolute risk difference -1·4%, 95% CI -7·0 to 4·3; hazard ratio 0·96, 0·68-1·35, p=0·81). From randomisation to 12 weeks, no evidence of differences in serious (p=0·17) or grade 3-4 (p=0·36) adverse events were observed; however, 63 (17%) participants in the rifampicin group versus 39 (10%) in the placebo group had antibiotic or trial drug-modifying adverse events (p=0·004), and 24 (6%) versus six (2%) had drug interactions (p=0·0005).

INTERPRETATION:

Adjunctive rifampicin provided no overall benefit over standard antibiotic therapy in adults with S aureus bacteraemia.

FUNDING:

UK National Institute for Health Research Health Technology Assessment.
0140-6736
668-678
Clark, Tristan
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Thwaites, Guy
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Scarborough, Matthew
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Szubert, Alexander J.
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Nsutebu, Emmanuel
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Tilley, Robert
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Greig, Julia
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Wyllie, Sarah
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Wilson, Peter
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Auckland, Cressida
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Cairns, Janet
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Ward, Denise
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Lal, Pankaj
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Guleri, Achyut
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Jenkins, Neil
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Sutton, Julian
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Wiselka, Martin
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Gonzalez-Ruiz, Armando
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Graham, Clive
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Chadwick, Paul
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Barlow, Gavin
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Gordon, N. Claire
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Young, Bernadette
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Meisner, Sarah
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McWhinney, Paul
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Price, David A.
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Harvey, David J.
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Nayar, Deepa
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Jeyaratnam, Dakshika
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Planche, Tim
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Minton, Jane
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Hudson, Fleur
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Hopkins, Susan
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Williams, John
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Török, M. Estée
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Llewelyn, Martin J.
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Edgeworth, Jonathan
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Walker, A. Sarah
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on behalf of the United Kingdom Clinical Infection Research Group (UKCIRG)
Clark, Tristan
712ec18e-613c-45df-a013-c8a22834e14f
Thwaites, Guy
a5b2b0b1-fd73-4195-8038-d0a09134b956
Scarborough, Matthew
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Szubert, Alexander J.
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Nsutebu, Emmanuel
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Tilley, Robert
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Greig, Julia
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Wyllie, Sarah
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Wilson, Peter
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Auckland, Cressida
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Cairns, Janet
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Ward, Denise
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Lal, Pankaj
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Guleri, Achyut
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Jenkins, Neil
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Sutton, Julian
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Wiselka, Martin
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Gonzalez-Ruiz, Armando
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Graham, Clive
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Chadwick, Paul
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Barlow, Gavin
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Gordon, N. Claire
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Young, Bernadette
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Meisner, Sarah
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McWhinney, Paul
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Price, David A.
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Harvey, David J.
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Nayar, Deepa
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Jeyaratnam, Dakshika
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Planche, Tim
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Minton, Jane
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Hudson, Fleur
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Hopkins, Susan
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Williams, John
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Török, M. Estée
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Llewelyn, Martin J.
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Edgeworth, Jonathan
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Walker, A. Sarah
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Thwaites, Guy, Scarborough, Matthew, Szubert, Alexander J., Nsutebu, Emmanuel, Tilley, Robert, Greig, Julia, Wyllie, Sarah, Wilson, Peter, Auckland, Cressida, Cairns, Janet, Ward, Denise, Lal, Pankaj, Guleri, Achyut, Jenkins, Neil, Sutton, Julian, Wiselka, Martin, Gonzalez-Ruiz, Armando, Graham, Clive, Chadwick, Paul, Barlow, Gavin, Gordon, N. Claire, Young, Bernadette, Meisner, Sarah, McWhinney, Paul, Price, David A., Harvey, David J., Nayar, Deepa, Jeyaratnam, Dakshika, Planche, Tim, Minton, Jane, Hudson, Fleur, Hopkins, Susan, Williams, John, Török, M. Estée, Llewelyn, Martin J., Edgeworth, Jonathan and Walker, A. Sarah , on behalf of the United Kingdom Clinical Infection Research Group (UKCIRG) (2018) Adjunctive rifampicin for Staphylococcus aureus bacteraemia (ARREST): a multicentre, randomised, double-blind, placebo-controlled trial. The Lancet, 391 (10121), 668-678. (doi:10.1016/S0140-6736(17)32456-X).

Record type: Article

Abstract

BACKGROUND:

Staphylococcus aureus bacteraemia is a common cause of severe community-acquired and hospital-acquired infection worldwide. We tested the hypothesis that adjunctive rifampicin would reduce bacteriologically confirmed treatment failure or disease recurrence, or death, by enhancing early S aureus killing, sterilising infected foci and blood faster, and reducing risks of dissemination and metastatic infection.

METHODS:

In this multicentre, randomised, double-blind, placebo-controlled trial, adults (≥18 years) with S aureus bacteraemia who had received ≤96 h of active antibiotic therapy were recruited from 29 UK hospitals. Patients were randomly assigned (1:1) via a computer-generated sequential randomisation list to receive 2 weeks of adjunctive rifampicin (600 mg or 900 mg per day according to weight, oral or intravenous) versus identical placebo, together with standard antibiotic therapy. Randomisation was stratified by centre. Patients, investigators, and those caring for the patients were masked to group allocation. The primary outcome was time to bacteriologically confirmed treatment failure or disease recurrence, or death (all-cause), from randomisation to 12 weeks, adjudicated by an independent review committee masked to the treatment. Analysis was intention to treat. This trial was registered, number ISRCTN37666216, and is closed to new participants.

FINDINGS:

Between Dec 10, 2012, and Oct 25, 2016, 758 eligible participants were randomly assigned: 370 to rifampicin and 388 to placebo. 485 (64%) participants had community-acquired S aureus infections, and 132 (17%) had nosocomial S aureus infections. 47 (6%) had meticillin-resistant infections. 301 (40%) participants had an initial deep infection focus. Standard antibiotics were given for 29 (IQR 18-45) days; 619 (82%) participants received flucloxacillin. By week 12, 62 (17%) of participants who received rifampicin versus 71 (18%) who received placebo experienced treatment failure or disease recurrence, or died (absolute risk difference -1·4%, 95% CI -7·0 to 4·3; hazard ratio 0·96, 0·68-1·35, p=0·81). From randomisation to 12 weeks, no evidence of differences in serious (p=0·17) or grade 3-4 (p=0·36) adverse events were observed; however, 63 (17%) participants in the rifampicin group versus 39 (10%) in the placebo group had antibiotic or trial drug-modifying adverse events (p=0·004), and 24 (6%) versus six (2%) had drug interactions (p=0·0005).

INTERPRETATION:

Adjunctive rifampicin provided no overall benefit over standard antibiotic therapy in adults with S aureus bacteraemia.

FUNDING:

UK National Institute for Health Research Health Technology Assessment.

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e-pub ahead of print date: 14 December 2017
Published date: 17 February 2018

Identifiers

Local EPrints ID: 426130
URI: http://eprints.soton.ac.uk/id/eprint/426130
ISSN: 0140-6736
PURE UUID: 5329d85a-deba-44a2-9c26-f8682e3e660d
ORCID for Tristan Clark: ORCID iD orcid.org/0000-0001-6026-5295

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Date deposited: 15 Nov 2018 17:30
Last modified: 16 Aug 2024 01:47

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Contributors

Author: Tristan Clark ORCID iD
Author: Guy Thwaites
Author: Matthew Scarborough
Author: Alexander J. Szubert
Author: Emmanuel Nsutebu
Author: Robert Tilley
Author: Julia Greig
Author: Sarah Wyllie
Author: Peter Wilson
Author: Cressida Auckland
Author: Janet Cairns
Author: Denise Ward
Author: Pankaj Lal
Author: Achyut Guleri
Author: Neil Jenkins
Author: Julian Sutton
Author: Martin Wiselka
Author: Armando Gonzalez-Ruiz
Author: Clive Graham
Author: Paul Chadwick
Author: Gavin Barlow
Author: N. Claire Gordon
Author: Bernadette Young
Author: Sarah Meisner
Author: Paul McWhinney
Author: David A. Price
Author: David J. Harvey
Author: Deepa Nayar
Author: Dakshika Jeyaratnam
Author: Tim Planche
Author: Jane Minton
Author: Fleur Hudson
Author: Susan Hopkins
Author: John Williams
Author: M. Estée Török
Author: Martin J. Llewelyn
Author: Jonathan Edgeworth
Author: A. Sarah Walker
Corporate Author: on behalf of the United Kingdom Clinical Infection Research Group (UKCIRG)

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