Sputum culture conversion as a prognostic marker for end-of-treatment outcome in patients with multidrug-resistant tuberculosis: a secondary analysis of data from two observational cohort studies
Sputum culture conversion is often used as an early microbiological endpoint in phase 2 clinical trials of tuberculosis treatment on the basis of its assumed predictive value for end-of-treatment outcome, particularly in patients with drug-susceptible tuberculosis. We aimed to assess the validity of...
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| Vydáno v: | The lancet respiratory medicine Ročník 3; číslo 3; s. 201 - 209 |
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| Médium: | Journal Article |
| Jazyk: | angličtina |
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01.03.2015
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| ISSN: | 2213-2619 |
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| Abstract | Sputum culture conversion is often used as an early microbiological endpoint in phase 2 clinical trials of tuberculosis treatment on the basis of its assumed predictive value for end-of-treatment outcome, particularly in patients with drug-susceptible tuberculosis. We aimed to assess the validity of sputum culture conversion on solid media at varying timepoints, and the time to conversion, as prognostic markers for end-of-treatment outcome in patients with multidrug-resistant (MDR) tuberculosis.
We analysed data from two large cohort studies of patients with MDR tuberculosis. We defined sputum culture conversion as two or more consecutive negative cultures from sputum samples obtained at least 30 days apart. To estimate the association of 2 month and 6 month conversion with successful treatment outcome, we calculated odds ratios (ORs) and 95% CIs with random-effects multivariable logistic regression. We calculated predictive values with bivariate random-effects generalised linear mixed modelling.
We assessed data for 1712 patients who had treatment success, treatment failure, or who died. Among patients with treatment success, median time to sputum culture conversion was significantly shorter than in those who had poor outcomes (2 months [IQR 1-3] vs 7 months [3 to ≥24]; log-rank p<0·0001). Furthermore, conversion status at 6 months (adjusted OR 14·07 [95% CI 10·05-19·71]) was significantly associated with treatment success compared with failure or death. Sputum culture conversion status at 2 months was significantly associated with treatment success only in patients who were HIV negative (adjusted OR 4·12 [95% CI 2·25-7·54]) or who had unknown HIV infection (3·59 [1·96-6·58]), but not in those who were HIV positive (0·38 [0·12-1·18]). Thus, the overall association of sputum culture conversion with a successful outcome was substantially greater at 6 months than at 2 months. 2 month conversion had low sensitivity (27·3% [95% confidence limit 16·6-41·4]) and high specificity (89·8% [82·3-94·4]) for prediction of treatment success. Conversely, 6 month sputum culture conversion status had high sensitivity (91·8% [85·9-95·4]), but moderate specificity (57·8% [42·5-71·6]). The maximum combined sensitivity and specificity for sputum culture conversion was reached between month 6 and month 10 of treatment.
Time to sputum culture conversion, conversion status at 6 months, and conversion status at 2 months in patients without known HIV infection can be considered as proxy markers of end-of-treatment outcome in patients with MDR tuberculosis, although the overall association with treatment success is substantially stronger for 6 month than for 2 month conversion status. Investigators should consider these results regarding the validity of sputum culture conversion at various timepoints as an early predictor of treatment efficacy when designing phase 2 studies before investing substantial resources in large, long-term, phase 3 trials of new treatments for MDR tuberculosis.
US Agency for International Development, US Centers for Disease Control and Prevention, Division of Intramural Research of the US National Institute of Allergy and Infectious Diseases, Korea Centers for Disease Control and Prevention. |
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| AbstractList | BACKGROUNDSputum culture conversion is often used as an early microbiological endpoint in phase 2 clinical trials of tuberculosis treatment on the basis of its assumed predictive value for end-of-treatment outcome, particularly in patients with drug-susceptible tuberculosis. We aimed to assess the validity of sputum culture conversion on solid media at varying timepoints, and the time to conversion, as prognostic markers for end-of-treatment outcome in patients with multidrug-resistant (MDR) tuberculosis.METHODSWe analysed data from two large cohort studies of patients with MDR tuberculosis. We defined sputum culture conversion as two or more consecutive negative cultures from sputum samples obtained at least 30 days apart. To estimate the association of 2 month and 6 month conversion with successful treatment outcome, we calculated odds ratios (ORs) and 95% CIs with random-effects multivariable logistic regression. We calculated predictive values with bivariate random-effects generalised linear mixed modelling.FINDINGSWe assessed data for 1712 patients who had treatment success, treatment failure, or who died. Among patients with treatment success, median time to sputum culture conversion was significantly shorter than in those who had poor outcomes (2 months [IQR 1-3] vs 7 months [3 to ≥24]; log-rank p<0·0001). Furthermore, conversion status at 6 months (adjusted OR 14·07 [95% CI 10·05-19·71]) was significantly associated with treatment success compared with failure or death. Sputum culture conversion status at 2 months was significantly associated with treatment success only in patients who were HIV negative (adjusted OR 4·12 [95% CI 2·25-7·54]) or who had unknown HIV infection (3·59 [1·96-6·58]), but not in those who were HIV positive (0·38 [0·12-1·18]). Thus, the overall association of sputum culture conversion with a successful outcome was substantially greater at 6 months than at 2 months. 2 month conversion had low sensitivity (27·3% [95% confidence limit 16·6-41·4]) and high specificity (89·8% [82·3-94·4]) for prediction of treatment success. Conversely, 6 month sputum culture conversion status had high sensitivity (91·8% [85·9-95·4]), but moderate specificity (57·8% [42·5-71·6]). The maximum combined sensitivity and specificity for sputum culture conversion was reached between month 6 and month 10 of treatment.INTERPRETATIONTime to sputum culture conversion, conversion status at 6 months, and conversion status at 2 months in patients without known HIV infection can be considered as proxy markers of end-of-treatment outcome in patients with MDR tuberculosis, although the overall association with treatment success is substantially stronger for 6 month than for 2 month conversion status. Investigators should consider these results regarding the validity of sputum culture conversion at various timepoints as an early predictor of treatment efficacy when designing phase 2 studies before investing substantial resources in large, long-term, phase 3 trials of new treatments for MDR tuberculosis.FUNDINGUS Agency for International Development, US Centers for Disease Control and Prevention, Division of Intramural Research of the US National Institute of Allergy and Infectious Diseases, Korea Centers for Disease Control and Prevention. Sputum culture conversion is often used as an early microbiological endpoint in phase 2 clinical trials of tuberculosis treatment on the basis of its assumed predictive value for end-of-treatment outcome, particularly in patients with drug-susceptible tuberculosis. We aimed to assess the validity of sputum culture conversion on solid media at varying timepoints, and the time to conversion, as prognostic markers for end-of-treatment outcome in patients with multidrug-resistant (MDR) tuberculosis. We analysed data from two large cohort studies of patients with MDR tuberculosis. We defined sputum culture conversion as two or more consecutive negative cultures from sputum samples obtained at least 30 days apart. To estimate the association of 2 month and 6 month conversion with successful treatment outcome, we calculated odds ratios (ORs) and 95% CIs with random-effects multivariable logistic regression. We calculated predictive values with bivariate random-effects generalised linear mixed modelling. We assessed data for 1712 patients who had treatment success, treatment failure, or who died. Among patients with treatment success, median time to sputum culture conversion was significantly shorter than in those who had poor outcomes (2 months [IQR 1-3] vs 7 months [3 to ≥24]; log-rank p<0·0001). Furthermore, conversion status at 6 months (adjusted OR 14·07 [95% CI 10·05-19·71]) was significantly associated with treatment success compared with failure or death. Sputum culture conversion status at 2 months was significantly associated with treatment success only in patients who were HIV negative (adjusted OR 4·12 [95% CI 2·25-7·54]) or who had unknown HIV infection (3·59 [1·96-6·58]), but not in those who were HIV positive (0·38 [0·12-1·18]). Thus, the overall association of sputum culture conversion with a successful outcome was substantially greater at 6 months than at 2 months. 2 month conversion had low sensitivity (27·3% [95% confidence limit 16·6-41·4]) and high specificity (89·8% [82·3-94·4]) for prediction of treatment success. Conversely, 6 month sputum culture conversion status had high sensitivity (91·8% [85·9-95·4]), but moderate specificity (57·8% [42·5-71·6]). The maximum combined sensitivity and specificity for sputum culture conversion was reached between month 6 and month 10 of treatment. Time to sputum culture conversion, conversion status at 6 months, and conversion status at 2 months in patients without known HIV infection can be considered as proxy markers of end-of-treatment outcome in patients with MDR tuberculosis, although the overall association with treatment success is substantially stronger for 6 month than for 2 month conversion status. Investigators should consider these results regarding the validity of sputum culture conversion at various timepoints as an early predictor of treatment efficacy when designing phase 2 studies before investing substantial resources in large, long-term, phase 3 trials of new treatments for MDR tuberculosis. US Agency for International Development, US Centers for Disease Control and Prevention, Division of Intramural Research of the US National Institute of Allergy and Infectious Diseases, Korea Centers for Disease Control and Prevention. |
| Author | Gelmanova, Irina Bayona, Jaime Jou, Ruwen Kliiman, Kai Gammino, Victoria M Quelapio, Imelda Wolfgang, Melanie Kvasnovsky, Charlotte Kim, Hee Jin Lienhardt, Christian Kazennyy, Boris Yagui, Martin Dalton, Tracy Ershova, Julia Via, Laura E Keshavjee, Salmaan Smith, Sarah E Viiklepp, Piret Demikhova, Olga V Heilig, Charles M Kurbatova, Ekaterina V Volchenkov, Grigory Akksilp, Rattanawadee Caoili, Janice Walker, Allison Taylor Danilovits, Manfred Cegielski, J Peter Becerra, Mercedes C van der Walt, Martie Leimane, Vaira Vasilyeva, Irina A Riekstina, Vija Tupasi, Thelma Contreras, Carmen Mitnick, Carole D Zignol, Matteo |
| Author_xml | – sequence: 1 givenname: Ekaterina V surname: Kurbatova fullname: Kurbatova, Ekaterina V email: ekurbatova@cdc.gov organization: Division of Tuberculosis Elimination, US Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: ekurbatova@cdc.gov – sequence: 2 givenname: J Peter surname: Cegielski fullname: Cegielski, J Peter organization: Division of Tuberculosis Elimination, US Centers for Disease Control and Prevention, Atlanta, GA, USA – sequence: 3 givenname: Christian surname: Lienhardt fullname: Lienhardt, Christian organization: WHO, Geneva, Switzerland – sequence: 4 givenname: Rattanawadee surname: Akksilp fullname: Akksilp, Rattanawadee organization: Office of Disease Prevention and Control, Region 7, Ubon Ratchathani, Thailand – sequence: 5 givenname: Jaime surname: Bayona fullname: Bayona, Jaime organization: Harvard Medical School and Partners In Health, Boston, MA, USA – sequence: 6 givenname: Mercedes C surname: Becerra fullname: Becerra, Mercedes C organization: Harvard Medical School and Partners In Health, Boston, MA, USA – sequence: 7 givenname: Janice surname: Caoili fullname: Caoili, Janice organization: Tropical Disease Foundation, Manila, Philippines – sequence: 8 givenname: Carmen surname: Contreras fullname: Contreras, Carmen organization: Socios en Salud Sucursal, Lima, Peru – sequence: 9 givenname: Tracy surname: Dalton fullname: Dalton, Tracy organization: Division of Tuberculosis Elimination, US Centers for Disease Control and Prevention, Atlanta, GA, USA – sequence: 10 givenname: Manfred surname: Danilovits fullname: Danilovits, Manfred organization: Tartu University Hospital, Tartu, Estonia – sequence: 11 givenname: Olga V surname: Demikhova fullname: Demikhova, Olga V organization: Central Tuberculosis Research Institute, Russian Academy of Medical Sciences, Moscow, Russia – sequence: 12 givenname: Julia surname: Ershova fullname: Ershova, Julia organization: Division of Tuberculosis Elimination, US Centers for Disease Control and Prevention, Atlanta, GA, USA – sequence: 13 givenname: Victoria M surname: Gammino fullname: Gammino, Victoria M organization: Division of Tuberculosis Elimination, US Centers for Disease Control and Prevention, Atlanta, GA, USA – sequence: 14 givenname: Irina surname: Gelmanova fullname: Gelmanova, Irina organization: Harvard Medical School and Partners In Health, Boston, MA, USA – sequence: 15 givenname: Charles M surname: Heilig fullname: Heilig, Charles M organization: Division of Tuberculosis Elimination, US Centers for Disease Control and Prevention, Atlanta, GA, USA – sequence: 16 givenname: Ruwen surname: Jou fullname: Jou, Ruwen organization: Reference Laboratory of Mycobacteriology, Taiwan Centers for Disease Control, Taipei, Taiwan – sequence: 17 givenname: Boris surname: Kazennyy fullname: Kazennyy, Boris organization: Orel Oblast Tuberculosis Dispensary, Orel, Russia – sequence: 18 givenname: Salmaan surname: Keshavjee fullname: Keshavjee, Salmaan organization: Harvard Medical School and Partners In Health, Boston, MA, USA – sequence: 19 givenname: Hee Jin surname: Kim fullname: Kim, Hee Jin organization: Korean Institute of Tuberculosis, Seoul, South Korea – sequence: 20 givenname: Kai surname: Kliiman fullname: Kliiman, Kai organization: Tartu University Hospital, Tartu, Estonia – sequence: 21 givenname: Charlotte surname: Kvasnovsky fullname: Kvasnovsky, Charlotte organization: Division of Tuberculosis Elimination, US Centers for Disease Control and Prevention, Atlanta, GA, USA – sequence: 22 givenname: Vaira surname: Leimane fullname: Leimane, Vaira organization: Riga East University Hospital, Tuberculosis and Lung Disease Center, Riga, Latvia – sequence: 23 givenname: Carole D surname: Mitnick fullname: Mitnick, Carole D organization: Harvard Medical School and Partners In Health, Boston, MA, USA – sequence: 24 givenname: Imelda surname: Quelapio fullname: Quelapio, Imelda organization: Tropical Disease Foundation, Manila, Philippines – sequence: 25 givenname: Vija surname: Riekstina fullname: Riekstina, Vija organization: Riga East University Hospital, Tuberculosis and Lung Disease Center, Riga, Latvia – sequence: 26 givenname: Sarah E surname: Smith fullname: Smith, Sarah E organization: Division of Tuberculosis Elimination, US Centers for Disease Control and Prevention, Atlanta, GA, USA – sequence: 27 givenname: Thelma surname: Tupasi fullname: Tupasi, Thelma organization: Tropical Disease Foundation, Manila, Philippines – sequence: 28 givenname: Martie surname: van der Walt fullname: van der Walt, Martie organization: Medical Research Council, Pretoria, South Africa – sequence: 29 givenname: Irina A surname: Vasilyeva fullname: Vasilyeva, Irina A organization: Central Tuberculosis Research Institute, Russian Academy of Medical Sciences, Moscow, Russia – sequence: 30 givenname: Laura E surname: Via fullname: Via, Laura E organization: National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA – sequence: 31 givenname: Piret surname: Viiklepp fullname: Viiklepp, Piret organization: National Tuberculosis Registry, National Institute for Health Development, Tallinn, Estonia – sequence: 32 givenname: Grigory surname: Volchenkov fullname: Volchenkov, Grigory organization: Vladimir Oblast Tuberculosis Dispensary, Vladimir, Russia – sequence: 33 givenname: Allison Taylor surname: Walker fullname: Walker, Allison Taylor organization: Division of Tuberculosis Elimination, US Centers for Disease Control and Prevention, Atlanta, GA, USA – sequence: 34 givenname: Melanie surname: Wolfgang fullname: Wolfgang, Melanie organization: Division of Tuberculosis Elimination, US Centers for Disease Control and Prevention, Atlanta, GA, USA – sequence: 35 givenname: Martin surname: Yagui fullname: Yagui, Martin organization: National Institute of Health, Lima, Peru – sequence: 36 givenname: Matteo surname: Zignol fullname: Zignol, Matteo organization: WHO, Geneva, Switzerland |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/25726085$$D View this record in MEDLINE/PubMed |
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| Snippet | Sputum culture conversion is often used as an early microbiological endpoint in phase 2 clinical trials of tuberculosis treatment on the basis of its assumed... BACKGROUNDSputum culture conversion is often used as an early microbiological endpoint in phase 2 clinical trials of tuberculosis treatment on the basis of its... |
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| SubjectTerms | Adolescent Adult Aged Humans Middle Aged Mycobacterium tuberculosis - isolation & purification Prospective Studies Sputum - microbiology Treatment Outcome Tuberculosis, Multidrug-Resistant - drug therapy Tuberculosis, Pulmonary - drug therapy Young Adult |
| Title | Sputum culture conversion as a prognostic marker for end-of-treatment outcome in patients with multidrug-resistant tuberculosis: a secondary analysis of data from two observational cohort studies |
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