We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Study protocol for safety and efficacy of all-oral shortened regimens for multidrug-resistant tuberculosis: a multicenter randomized withdrawal trial and a single-arm trial [SEAL-MDR].
- Authors
Fu, Liang; Xiong, Juan; Wang, Haibo; Zhang, Peize; Yang, Qianting; Cai, Yi; Wang, Wenfei; Sun, Feng; Zhang, Xilin; Wang, Zhaoqin; Chen, Xinchun; Zhang, Wenhong; Deng, Guofang
- Abstract
Introduction: The urgent need for new treatments for multidrug-resistant tuberculosis (MDR-TB) and pre-extensively drug-resistant tuberculosis (pre-XDR-TB) is evident. However, the classic randomized controlled trial (RCT) approach faces ethical and practical constraints, making alternative research designs and treatment strategies necessary, such as single-arm trials and host-directed therapies (HDTs). Methods: Our study adopts a randomized withdrawal trial design for MDR-TB to maximize resource allocation and better mimic real-world conditions. Patients' treatment regimens are initially based on drug resistance profiles and patient's preference, and later, treatment-responsive cases are randomized to different treatment durations. Alongside, a single-arm trial is being conducted to evaluate the potential of sulfasalazine (SASP) as an HDT for pre-XDR-TB, as well as another short-course regimen without HDT for pre-XDR-TB. Both approaches account for the limitations in second-line anti-TB drug resistance testing in various regions. Discussion: Although our study designs may lack the internal validity commonly associated with RCTs, they offer advantages in external validity, feasibility, and ethical appropriateness. These designs align with real-world clinical settings and also open doors for exploring alternative treatments like SASP for tackling drug-resistant TB forms. Ultimately, our research aims to strike a balance between scientific rigor and practical utility, offering valuable insights into treating MDR-TB and pre-XDR-TB in a challenging global health landscape. In summary, our study employs innovative trial designs and treatment strategies to address the complexities of treating drug-resistant TB, fulfilling a critical gap between ideal clinical trials and the reality of constrained resources and ethical considerations. Trail registration: Chictr.org.cn, ChiCTR2100045930. Registered on April 29, 2021.
- Subjects
MULTIDRUG-resistant tuberculosis; RESEARCH protocols; RANDOMIZED controlled trials; PATIENT preferences; DRUG resistance
- Publication
BMC Infectious Diseases, 2023, Vol 23, Issue 1, p1
- ISSN
1471-2334
- Publication type
Article
- DOI
10.1186/s12879-023-08644-8