Universidad Peruana Cayetano Heredia
Factors associated with screening failure and study withdrawal in multidrug-resistant TB
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| 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 |
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