Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition

P. N.A. Harris, J. F. McNamara, D. L. Paterson, D. C. Lye, J. S. Davis, S. Y.C. Tong, L. Bernard, A. C. Cheng, Y. Doi, V. G. Fowler, K. S. Kaye, L. Leibovici, J. Lipman, M. J. Llewelyn, S. Munoz-Price, M. Paul, A. Y. Peleg, B. A. Rogers, J. Rodríguez-Baño, H. SeifertV. Thamlikitkul, G. Thwaites, J. Turnidge, R. Utili, S. A.R. Webb

研究成果: Short survey

17 引用 (Scopus)

抄録

Objectives To define standardized endpoints to aid the design of trials that compare antibiotic therapies for bloodstream infections (BSI). Methods Prospective studies, randomized trials or registered protocols comparing antibiotic therapies for BSI, published from 2005 to 2016, were reviewed. Consensus endpoints for BSI studies were defined using a modified Delphi process. Results Different primary and secondary endpoints were defined for pilot (small-scale studies designed to evaluate protocol design, feasibility and implementation) and definitive trials (larger-scale studies designed to test hypotheses and influence clinical practice), as well as for Staphylococcus aureus and Gram-negative BSI. For pilot studies of S. aureus BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever, stable/improved Sequential Organ Failure Assessment (SOFA) score and clearance of blood cultures, with no microbiologically confirmed failure up to 90 days. For definitive S. aureus BSI studies, a primary outcome of success at 90 days was defined by survival and no microbiologically confirmed failure. For pilot studies of Gram-negative BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever and symptoms related to BSI source, stable or improved SOFA score and negative blood cultures. For definitive Gram-negative BSI studies, a primary outcome of survival at 90 days supported by a secondary outcome of success at day 7 (as previously defined) was agreed. Conclusions These endpoints provide a framework to aid future trial design. Further work will be required to validate these endpoints with respect to patient-centred clinical outcomes.

元の言語English
ページ(範囲)533-541
ページ数9
ジャーナルClinical Microbiology and Infection
23
発行部数8
DOI
出版物ステータスPublished - 01-08-2017

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Clinical Trials
Infection
Organ Dysfunction Scores
Staphylococcus aureus
Survival
Fever
Anti-Bacterial Agents
Prospective Studies
Therapeutics

All Science Journal Classification (ASJC) codes

  • Microbiology (medical)
  • Infectious Diseases

これを引用

Harris, P. N.A. ; McNamara, J. F. ; Paterson, D. L. ; Lye, D. C. ; Davis, J. S. ; Tong, S. Y.C. ; Bernard, L. ; Cheng, A. C. ; Doi, Y. ; Fowler, V. G. ; Kaye, K. S. ; Leibovici, L. ; Lipman, J. ; Llewelyn, M. J. ; Munoz-Price, S. ; Paul, M. ; Peleg, A. Y. ; Rogers, B. A. ; Rodríguez-Baño, J. ; Seifert, H. ; Thamlikitkul, V. ; Thwaites, G. ; Turnidge, J. ; Utili, R. ; Webb, S. A.R. / Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults : a consensus definition. :: Clinical Microbiology and Infection. 2017 ; 巻 23, 番号 8. pp. 533-541.
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abstract = "Objectives To define standardized endpoints to aid the design of trials that compare antibiotic therapies for bloodstream infections (BSI). Methods Prospective studies, randomized trials or registered protocols comparing antibiotic therapies for BSI, published from 2005 to 2016, were reviewed. Consensus endpoints for BSI studies were defined using a modified Delphi process. Results Different primary and secondary endpoints were defined for pilot (small-scale studies designed to evaluate protocol design, feasibility and implementation) and definitive trials (larger-scale studies designed to test hypotheses and influence clinical practice), as well as for Staphylococcus aureus and Gram-negative BSI. For pilot studies of S. aureus BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever, stable/improved Sequential Organ Failure Assessment (SOFA) score and clearance of blood cultures, with no microbiologically confirmed failure up to 90 days. For definitive S. aureus BSI studies, a primary outcome of success at 90 days was defined by survival and no microbiologically confirmed failure. For pilot studies of Gram-negative BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever and symptoms related to BSI source, stable or improved SOFA score and negative blood cultures. For definitive Gram-negative BSI studies, a primary outcome of survival at 90 days supported by a secondary outcome of success at day 7 (as previously defined) was agreed. Conclusions These endpoints provide a framework to aid future trial design. Further work will be required to validate these endpoints with respect to patient-centred clinical outcomes.",
author = "Harris, {P. N.A.} and McNamara, {J. F.} and Paterson, {D. L.} and Lye, {D. C.} and Davis, {J. S.} and Tong, {S. Y.C.} and L. Bernard and Cheng, {A. C.} and Y. Doi and Fowler, {V. G.} and Kaye, {K. S.} and L. Leibovici and J. Lipman and Llewelyn, {M. J.} and S. Munoz-Price and M. Paul and Peleg, {A. Y.} and Rogers, {B. A.} and J. Rodr{\'i}guez-Ba{\~n}o and H. Seifert and V. Thamlikitkul and G. Thwaites and J. Turnidge and R. Utili and Webb, {S. A.R.}",
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Harris, PNA, McNamara, JF, Paterson, DL, Lye, DC, Davis, JS, Tong, SYC, Bernard, L, Cheng, AC, Doi, Y, Fowler, VG, Kaye, KS, Leibovici, L, Lipman, J, Llewelyn, MJ, Munoz-Price, S, Paul, M, Peleg, AY, Rogers, BA, Rodríguez-Baño, J, Seifert, H, Thamlikitkul, V, Thwaites, G, Turnidge, J, Utili, R & Webb, SAR 2017, 'Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition', Clinical Microbiology and Infection, 巻. 23, 番号 8, pp. 533-541. https://doi.org/10.1016/j.cmi.2016.10.023

Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults : a consensus definition. / Harris, P. N.A.; McNamara, J. F.; Paterson, D. L.; Lye, D. C.; Davis, J. S.; Tong, S. Y.C.; Bernard, L.; Cheng, A. C.; Doi, Y.; Fowler, V. G.; Kaye, K. S.; Leibovici, L.; Lipman, J.; Llewelyn, M. J.; Munoz-Price, S.; Paul, M.; Peleg, A. Y.; Rogers, B. A.; Rodríguez-Baño, J.; Seifert, H.; Thamlikitkul, V.; Thwaites, G.; Turnidge, J.; Utili, R.; Webb, S. A.R.

:: Clinical Microbiology and Infection, 巻 23, 番号 8, 01.08.2017, p. 533-541.

研究成果: Short survey

TY - JOUR

T1 - Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults

T2 - a consensus definition

AU - Harris, P. N.A.

AU - McNamara, J. F.

AU - Paterson, D. L.

AU - Lye, D. C.

AU - Davis, J. S.

AU - Tong, S. Y.C.

AU - Bernard, L.

AU - Cheng, A. C.

AU - Doi, Y.

AU - Fowler, V. G.

AU - Kaye, K. S.

AU - Leibovici, L.

AU - Lipman, J.

AU - Llewelyn, M. J.

AU - Munoz-Price, S.

AU - Paul, M.

AU - Peleg, A. Y.

AU - Rogers, B. A.

AU - Rodríguez-Baño, J.

AU - Seifert, H.

AU - Thamlikitkul, V.

AU - Thwaites, G.

AU - Turnidge, J.

AU - Utili, R.

AU - Webb, S. A.R.

PY - 2017/8/1

Y1 - 2017/8/1

N2 - Objectives To define standardized endpoints to aid the design of trials that compare antibiotic therapies for bloodstream infections (BSI). Methods Prospective studies, randomized trials or registered protocols comparing antibiotic therapies for BSI, published from 2005 to 2016, were reviewed. Consensus endpoints for BSI studies were defined using a modified Delphi process. Results Different primary and secondary endpoints were defined for pilot (small-scale studies designed to evaluate protocol design, feasibility and implementation) and definitive trials (larger-scale studies designed to test hypotheses and influence clinical practice), as well as for Staphylococcus aureus and Gram-negative BSI. For pilot studies of S. aureus BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever, stable/improved Sequential Organ Failure Assessment (SOFA) score and clearance of blood cultures, with no microbiologically confirmed failure up to 90 days. For definitive S. aureus BSI studies, a primary outcome of success at 90 days was defined by survival and no microbiologically confirmed failure. For pilot studies of Gram-negative BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever and symptoms related to BSI source, stable or improved SOFA score and negative blood cultures. For definitive Gram-negative BSI studies, a primary outcome of survival at 90 days supported by a secondary outcome of success at day 7 (as previously defined) was agreed. Conclusions These endpoints provide a framework to aid future trial design. Further work will be required to validate these endpoints with respect to patient-centred clinical outcomes.

AB - Objectives To define standardized endpoints to aid the design of trials that compare antibiotic therapies for bloodstream infections (BSI). Methods Prospective studies, randomized trials or registered protocols comparing antibiotic therapies for BSI, published from 2005 to 2016, were reviewed. Consensus endpoints for BSI studies were defined using a modified Delphi process. Results Different primary and secondary endpoints were defined for pilot (small-scale studies designed to evaluate protocol design, feasibility and implementation) and definitive trials (larger-scale studies designed to test hypotheses and influence clinical practice), as well as for Staphylococcus aureus and Gram-negative BSI. For pilot studies of S. aureus BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever, stable/improved Sequential Organ Failure Assessment (SOFA) score and clearance of blood cultures, with no microbiologically confirmed failure up to 90 days. For definitive S. aureus BSI studies, a primary outcome of success at 90 days was defined by survival and no microbiologically confirmed failure. For pilot studies of Gram-negative BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever and symptoms related to BSI source, stable or improved SOFA score and negative blood cultures. For definitive Gram-negative BSI studies, a primary outcome of survival at 90 days supported by a secondary outcome of success at day 7 (as previously defined) was agreed. Conclusions These endpoints provide a framework to aid future trial design. Further work will be required to validate these endpoints with respect to patient-centred clinical outcomes.

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U2 - 10.1016/j.cmi.2016.10.023

DO - 10.1016/j.cmi.2016.10.023

M3 - Short survey

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