A Short, All-oral Regimen for Pre-extensively Drug-resistant Tuberculosis: A Multicenter Open-label Single-arm Study
Bibliographic record
Abstract
BACKGROUND: Preextensively drug-resistant tuberculosis (pre-XDR-TB) remains a critical public health threat because of limited treatment options and significant disease burden. Existing regimens have shown high success rates but are often inaccessible globally, necessitating alternative options. METHODS: This study was an open-label, multicenter, single-arm study conducted in China to evaluate the efficacy and safety of a 6- to 9-month oral regimen. Eligible participants, aged 18-70 years with pulmonary pre-XDR-TB received a regimen of bedaquiline, linezolid, cycloserine, pyrazinamide, and/or clofazimine. Pyrazinamide was either replaced with clofazimine or retained without clofazimine based on molecular susceptibility results. The primary efficacy endpoint was the percentage of participants with a favorable outcome at 84 weeks after treatment initiation in the modified intention-to-treat population. RESULTS: A total of 89 patients with pre-XDR-TB were enrolled. At 84 weeks after treatment initiation in the modified intention-to-treat analysis, 62 of 80 participants (77.5%; 95% confidence interval, 67.2-85.3) had favorable outcomes. The 18 unfavorable outcomes were 5 regimen discontinuations or changes (6.3%; 4 due to adverse events and 1 decided by the local investigator), 4 bacteriological failures (5.0%), 4 withdrawals of consent (5.0%), 3 deaths (3.8%), and 2 losses to follow-up (2.5%). No relapse was reported after the end of treatment. Adverse events of grade 3 or higher were observed in 59.1% of participants, with QTc prolongation being the most frequently reported. CONCLUSIONS: This study demonstrated that an all-oral, bedaquiline-based regimen provides a viable treatment option for patients with pre-XDR-TB, achieving acceptable efficacy and manageable safety profiles.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".