Erratum to: Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials

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dc.contributor.authorPhillips, Patrick P J
dc.contributor.authorMendel, Carl M
dc.contributor.authorBurger, Divan A
dc.contributor.authorCrook, Angela M
dc.contributor.authorNunn, Andrew J
dc.contributor.authorDawson, Rodney
dc.contributor.authorDiacon, Andreas H
dc.contributor.authorGillespie, Stephen H
dc.date.accessioned2021-10-08T06:54:42Z
dc.date.available2021-10-08T06:54:42Z
dc.date.issued2016
dc.description.abstractBackgroundDespite recent increased clinical trials activity, no regimen has proved able to replace the standard 6-month regimen for drug-sensitive tuberculosis. Understanding the relationship between microbiological markers measured during treatment and long-term clinical outcomes is critical to evaluate their usefulness for decision-making for both individual patient care and for advancing novel regimens into time-consuming and expensive pivotal phase III trials.MethodsUsing data from the randomized controlled phase III trial REMoxTB, we evaluated sputum-based markers of speed of clearance of bacilli: time to smear negative status; time to culture negative status on LJ or in MGIT; daily rate of change of log10(TTP) to day 56; and smear or culture results at weeks 6, 8 or 12; as individual- and trial-level surrogate endpoints for long-term clinical outcome.ResultsTime to culture negative status on LJ or in MGIT, time to smear negative status and daily rate of change in log10(TTP) were each independent predictors of clinical outcome, adjusted for treatment (p <0.001). However, discrimination between low and high risk patients, as measured by the c-statistic, was modest and not much higher than the reference model adjusted for BMI, history of smoking, HIV status, cavitation, gender and MGIT TTP.ConclusionsCulture conversion during treatment for tuberculosis, however measured, has only a limited role in decision-making for advancing regimens into phase III trials or in predicting the outcome of treatment for individual patients. REMoxTB ClinicalTrials.gov number: NCT00864383.
dc.identifier.apacitationPhillips, P. P. J., Mendel, C. M., Burger, D. A., Crook, A. M., Nunn, A. J., Dawson, R., ... Gillespie, S. H. (2016). Erratum to: Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials. <i>BMC Medicine</i>, 14(1), 174 - 177. http://hdl.handle.net/11427/34317en_ZA
dc.identifier.chicagocitationPhillips, Patrick P J, Carl M Mendel, Divan A Burger, Angela M Crook, Andrew J Nunn, Rodney Dawson, Andreas H Diacon, and Stephen H Gillespie "Erratum to: Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials." <i>BMC Medicine</i> 14, 1. (2016): 174 - 177. http://hdl.handle.net/11427/34317en_ZA
dc.identifier.citationPhillips, P.P.J., Mendel, C.M., Burger, D.A., Crook, A.M., Nunn, A.J., Dawson, R., Diacon, A.H. & Gillespie, S.H. et al. 2016. Erratum to: Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials. <i>BMC Medicine.</i> 14(1):174 - 177. http://hdl.handle.net/11427/34317en_ZA
dc.identifier.issn1741-7015
dc.identifier.ris TY - Journal Article AU - Phillips, Patrick P J AU - Mendel, Carl M AU - Burger, Divan A AU - Crook, Angela M AU - Nunn, Andrew J AU - Dawson, Rodney AU - Diacon, Andreas H AU - Gillespie, Stephen H AB - BackgroundDespite recent increased clinical trials activity, no regimen has proved able to replace the standard 6-month regimen for drug-sensitive tuberculosis. Understanding the relationship between microbiological markers measured during treatment and long-term clinical outcomes is critical to evaluate their usefulness for decision-making for both individual patient care and for advancing novel regimens into time-consuming and expensive pivotal phase III trials.MethodsUsing data from the randomized controlled phase III trial REMoxTB, we evaluated sputum-based markers of speed of clearance of bacilli: time to smear negative status; time to culture negative status on LJ or in MGIT; daily rate of change of log10(TTP) to day 56; and smear or culture results at weeks 6, 8 or 12; as individual- and trial-level surrogate endpoints for long-term clinical outcome.ResultsTime to culture negative status on LJ or in MGIT, time to smear negative status and daily rate of change in log10(TTP) were each independent predictors of clinical outcome, adjusted for treatment (p <0.001). However, discrimination between low and high risk patients, as measured by the c-statistic, was modest and not much higher than the reference model adjusted for BMI, history of smoking, HIV status, cavitation, gender and MGIT TTP.ConclusionsCulture conversion during treatment for tuberculosis, however measured, has only a limited role in decision-making for advancing regimens into phase III trials or in predicting the outcome of treatment for individual patients. REMoxTB ClinicalTrials.gov number: NCT00864383. DA - 2016 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - BMC Medicine LK - https://open.uct.ac.za PY - 2016 SM - 1741-7015 T1 - Erratum to: Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials TI - Erratum to: Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials UR - http://hdl.handle.net/11427/34317 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/34317
dc.identifier.vancouvercitationPhillips PPJ, Mendel CM, Burger DA, Crook AM, Nunn AJ, Dawson R, et al. Erratum to: Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials. BMC Medicine. 2016;14(1):174 - 177. http://hdl.handle.net/11427/34317.en_ZA
dc.language.isoeng
dc.publisher.departmentDivision of Pulmonology
dc.publisher.facultyFaculty of Health Sciences
dc.sourceBMC Medicine
dc.source.journalissue1
dc.source.journalvolume14
dc.source.pagination174 - 177
dc.source.urihttps://dx.doi.org/10.1186/s12916-016-0565-y
dc.subject.otherAdult
dc.subject.otherAntitubercular Agents
dc.subject.otherBiomarkers
dc.subject.otherDecision Making
dc.subject.otherDisease Progression
dc.subject.otherDrug Resistance, Microbial
dc.subject.otherFemale
dc.subject.otherHumans
dc.subject.otherMale
dc.subject.otherMiddle Aged
dc.subject.otherPatient Care
dc.subject.otherSputum
dc.subject.otherTuberculosis
dc.subject.otherAntitubercular Agents
dc.subject.otherBiomarkers
dc.titleErratum to: Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials
dc.typeJournal Article
uct.type.publicationResearch
uct.type.resourceJournal Article
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