drugset / Trial / NCT05549115
Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection
RandomizedParallel-groupOpen-labelTreatment
Summary
The main objective of this trial is to assess whether a sequential therapy strategy based on molecular antibiotic susceptibility testing (including clarithromycin and fluoroquinolone) for H. pylori infection will improve the eradication rate compared to an empirical therapy.
Timeline
- Start
- 2022-09-20
- Primary completion
- 2024-02
- Completion
- 2024-02
Outcome
Missed primary endpoint
paper absolute risk difference -3.0%; odds ratio (OR) = 0.882, 95% confidence interval (CI, 0.614-1.268), p = 0.499 PMID 42144812 ↗
paper PCR-based susceptibility-guided sequential therapy did not demonstrate superiority over empirical treatment. PMID 42144812 ↗
Publications
- Lu K, Zou X, Lang C, Zang L, Yang X, Sang W, Wang J, Feng Q, Mu Y, Liu L, Xu C, Zhao J. Susceptibility-Guided Versus Empirical Therapy for Helicobacter pylori Infection in a High Resistance Setting: A Randomised Controlled Trial. Microbiologyopen. 2026 Jun;15(3):e70313. doi: 10.1002/mbo3.70313.
- Lu K, Lang C, Zou X, Zang L, Sang W, Feng Q, Mu Y, Liu L, Xu C, Zhao J. Susceptibility-guided sequential strategy versus empirical therapy for Helicobacter pylori infection: study protocol for a randomised controlled trial. Trials. 2023 Jun 19;24(1):413. doi: 10.1186/s13063-023-07457-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 750 mg | — |
| Subject | Amoxicillin | Other / unclassified | 1 g | — |
| Subject | Clarithromycin | Small molecule | 500 mg | — |
| Subject | Esomeprazole | Small molecule | 20 mg | — |
| Subject | Furazolidone | Small molecule | 100 mg | — |
| Subject | Levofloxacin | Small molecule | 500 mg | — |
| Subject | colloidal bismuth pectin | Unknown | 150 mg | — |