Efficacy of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR for Helicobacter pylori eradication: a protocol of a multicentre, open, randomised clinical trial
Abstract
Introduction: Helicobacter pylori is a major health problem, with the high prevalence of H. pylori and the increasing antibiotic resistance rate in China. Antibiotic resistance is the main reason for the failure of H. pylori eradication. This study aims to evaluate the efficacy and safety of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR (qPCR) for H. pylori eradication.
Methods and analysis: This is a multicentre, open, randomised clinical trial that will enroll 324 patients with H. pylori infection. Patients will be randomised to two groups for a 14-day treatment: Treatment group will be treated with proton pump inhibitor (PPI), bismuth with two different kinds of antibiotics susceptibly guided by string test coupled with qPCR, while control group will be treated empirically with PPI, bismuth with two different kinds of antibiotics. The types and dosages of bismuth, PPI and antibiotics administered in this trial are based on the 2022 Chinese Guidelines for the treatment of H. pylori infection and the Sixth Chinese National Consensus Report on the management of H. pylori infection. The primary endpoint is the eradication rate, while secondary endpoints include compliance, the incidence of adverse events and adverse drug reactions.
Ethics and dissemination: This study was approved by the ethics committee of the Third People's Hospital of Zhengzhou (No. 2024-04-001-K02). The results will be published in…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 324 participants or records.
Read the paper
Related studies
- Photochemical behavior of levofloxacin
- Promising Ursolic Acid as a Novel Antituberculosis Agent: Current Progress and Challenges
- Proof of principle concept for the analysis and functional prediction of rare genetic variants in the CYP2C19 and CYP2D6 genes
- Synthesis of [11C]levofloxacin
- Fabrication, characterization, and docking studies of furosemide-loaded nanosponges using the emulsion solvent diffusion method
- The Effect of Concomitant Administration of Proton Pump Inhibitors on the Pharmacokinetics of CDK4/6 Inhibitors in Rats: Implications for the Evaluation of Hepatic and Transporter-Mediated Drug–Drug Interactions
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.