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
© 2023. The Author(s)..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:23 |
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| Enthalten in: |
BMC infectious diseases - 23(2023), 1 vom: 27. Nov., Seite 834 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Fu, Liang [VerfasserIn] |
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| Links: |
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| Themen: |
Antitubercular Agents |
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| Anmerkungen: |
Date Completed 29.11.2023 Date Revised 30.11.2023 published: Electronic Citation Status MEDLINE |
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| doi: |
10.1186/s12879-023-08644-8 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 520 | |a © 2023. The Author(s). | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRAIL REGISTRATION: Chictr.org.cn, ChiCTR2100045930. Registered on April 29, 2021 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Efficacy | |
| 650 | 4 | |a Multidrug-resistant | |
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| 650 | 4 | |a Trial | |
| 650 | 4 | |a Tuberculosis | |
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| 700 | 1 | |a Zhang, Peize |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Qianting |e verfasserin |4 aut | |
| 700 | 1 | |a Cai, Yi |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Wenfei |e verfasserin |4 aut | |
| 700 | 1 | |a Sun, Feng |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Xilin |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Zhaoqin |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Xinchun |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Wenhong |e verfasserin |4 aut | |
| 700 | 1 | |a Deng, Guofang |e verfasserin |4 aut | |
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