Evidence map›Paper›PMID 42144812›Full record

Trial reportMicrobiologyOpen2026

Susceptibility-Guided Versus Empirical Therapy for Helicobacter pylori Infection in a High Resistance Setting: A Randomised Controlled Trial.

Kemei Lu, Xuefei Zou, Cuicui Lang, Lina Zang, Xuechao Yang, Weiwei Sang, Jinyan Wang, Qian Feng, Ying Mu, Lifeng Liu and 2 more

Registry-linked trialAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in MicrobiologyOpen, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05549115 (Susceptibility-Guided Sequential Therapy Versus Empirical Therapy for Helicobacter Pylori Infection), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05549115 naunknown statusnot on this map

Susceptibility-Guided Sequential Therapy Versus Empirical Therapy for Helicobacter Pylori Infection: a Randomised Controlled Trial

TypeinterventionalSponsorLiaocheng People's HospitalRan2022 to 2024Enrolled500ConditionsHelicobacter Pylori InfectionArmsclarithromycin-sensitive(first-line), clarithromycin-resistant(first-line), empirical therapy group first-line, levofloxacin-sensitive(rescue treatment), levofloxacin-resistant(rescue treatment)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Kemei LuDepartment of Gastroenterology, Liaocheng People's Hospital, Liaocheng, Shandong Province, China.
Xuefei ZouDepartment of Gastroenterology, Liaocheng People's Hospital, Liaocheng, Shandong Province, China.
Cuicui LangDepartment of Gastroenterology, Liaocheng People's Hospital, Liaocheng, Shandong Province, China.
Lina ZangDepartment of Gastroenterology, Liaocheng People's Hospital, Liaocheng, Shandong Province, China.
Xuechao YangDepartment of Gastroenterology, Liaocheng People's Hospital, Liaocheng, Shandong Province, China.
Weiwei SangDepartment of Gastroenterology, Liaocheng People's Hospital, Liaocheng, Shandong Province, China.
Jinyan WangDepartment of Gastroenterology, Liaocheng People's Hospital, Liaocheng, Shandong Province, China.
Qian FengDepartment of Gastroenterology, Liaocheng People's Hospital, Liaocheng, Shandong Province, China.ORCID 0000-0001-7203-5358
Ying MuDepartment of Gastroenterology, Liaocheng People's Hospital, Liaocheng, Shandong Province, China.
Lifeng LiuDepartment of Gastroenterology, Shandong Province Maternal and Child Health Care Hospital, Jinan, Shandong Province, China.ORCID 0000-0002-6363-3433
Chunhong XuDepartment of Gastroenterology, Central Hospital affiliated to Shandong First Medical University, Jinan, Shandong Province, China.
Jingrun ZhaoDepartment of Gastroenterology, Liaocheng People's Hospital, Liaocheng, Shandong Province, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Clarithromycin resistance is a major determinant of treatment failure, and the benefits of susceptibility-guided therapy in high-resistance settings remains incompletely understood. To evaluate the clinical effectiveness of the susceptibility-guided compared with the empirical therapy in treatment-naïve H. pylori infection in a high resistance setting. In this single-centre, randomised, superiority trial, 500 treatment-naïve adults were allocated (1:1) to susceptibility-guided sequential therapy (SGT) or empirical clarithromycin -containing quadruple therapy (ET). Clarithromycin and levofloxacin antimicrobial resistance were determined using PCR. The primary endpoint was first-line eradication in the intention-to-treat (ITT) population. Sensitivity analyses were performed using complete-case and multiple imputation approaches. Among the 494 analysed participants (244 SGT, 250 ET), resistance to clarithromycin and levofloxacin was 69.3% and 51.6%, respectively. In the ITT analysis, first-line eradication was achieved in 59.8% of participants in the SGT group and 62.8% in the ET group [absolute risk difference -3.0%; odds ratio (OR) = 0.882, 95% confidence interval (CI, 0.614-1.268), p = 0.499]. Per-protocol eradication rates were 84.4% and 89.7%, respectively [absolute risk difference -5.3%; OR = 0.620, 95% CI (0.328-1.173), p = 0.139]. Notably, despite a clarithromycin resistance rate approaching 70%, empirical clarithromycin-containing quadruple therapy achieved a high per-protocol eradication rate. Sensitivity analyses yielded consistent results. In a high resistance region, PCR-based susceptibility-guided sequential therapy did not demonstrate superiority over empirical treatment. However, empirical clarithromycin -containing quadruple therapy maintained satisfactory efficacy. Overall, these findings have implications for treatment strategy selection in high-resistance microbiological settings. Trial Registration: ClinicalTrials. gov Identifier: NCT05549115.

Indexed as

Anti-Bacterial AgentsClarithromycinDrug Resistance, BacterialHelicobacter InfectionsHelicobacter pyloriAdultAgedDrug Therapy, CombinationFemaleHumansLevofloxacinMaleMicrobial Sensitivity TestsMiddle AgedPolymerase Chain ReactionTreatment OutcomeAnti-Bacterial AgentsClarithromycinLevofloxacinantibiotic resistanceantimicrobial susceptibility testingHelicobacter pyloripolymerase chain reaction

Identifiers

PMID42144812
PMCPMC13181152

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.