dc.contributor.author |
Schwalb Calderon, Alvaro |
|
dc.contributor.author |
Cachay Figueroa, Rodrigo Antonio |
|
dc.contributor.author |
Wright, A. |
|
dc.contributor.author |
Phillips, P.P.J. |
|
dc.contributor.author |
Kaur, P. |
|
dc.contributor.author |
Diacon, A.H. |
|
dc.contributor.author |
Ugarte Gil, Cesar Augusto |
|
dc.contributor.author |
Mitnick, Carole D. |
|
dc.contributor.author |
Sterling, T.R. |
|
dc.contributor.author |
Gotuzzo Herencia, José Eduardo |
|
dc.contributor.author |
Horsburgh, C.R. |
|
dc.date.accessioned |
2022-11-15T23:04:40Z |
|
dc.date.available |
2022-11-15T23:04:40Z |
|
dc.date.issued |
2022 |
|
dc.identifier.uri |
https://hdl.handle.net/20.500.12866/12583 |
|
dc.description.abstract |
SETTING: Multidrug-resistant TB (MDR-TB) clinical trial in Lima, Peru and Cape Town, South Africa.OBJECTIVE: To identify baseline factors associated with screening failure and study withdrawal in an MDR-TB clinical trial.DESIGN: We screened patients for a randomized, blinded, Phase II trial which assessed culture conversion over the first 6 months of treatment with varying doses of levofloxacin plus an optimized background regimen (ClinicalTrials.gov: NCT01918397). We identified factors for screening failure and study withdrawal using Poisson regression to calculate prevalence ratios and Cox proportional hazard regression to calculate hazard ratios. We adjusted for factors with P < 0.2.RESULTS: Of the 255 patients screened, 144 (56.5%) failed screening. The most common reason for screening failure was an unsuitable resistance profile on sputum-based molecular susceptibility testing (n = 105, 72.9%). No significant baseline predictors of screening failure were identified in the multivariable model. Of the 111 who were enrolled, 33 (30%) failed to complete treatment, mostly for non-adherence and consent withdrawal. No baseline factors predicted study withdrawal in the multivariable model.CONCLUSION: No baseline factors were independently associated with either screening failure or study withdrawal in this secondary analysis of a MDR-TB clinical trial. |
en_US |
dc.language.iso |
eng |
|
dc.publisher |
International Union Against Tuberculosis and Lung Disease |
|
dc.relation.ispartofseries |
International Journal of Tuberculosis and Lung Disease |
|
dc.rights |
info:eu-repo/semantics/restrictedAccess |
|
dc.rights.uri |
https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es |
|
dc.subject |
non-adherence |
en_US |
dc.subject |
patient retention |
en_US |
dc.subject |
treatment outcome |
en_US |
dc.title |
Factors associated with screening failure and study withdrawal in multidrug-resistant TB |
en_US |
dc.type |
info:eu-repo/semantics/article |
|
dc.identifier.doi |
https://doi.org/10.5588/ijtld.21.0729 |
|
dc.relation.issn |
1815-7920 |
|