NCT04107194

Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection.

Comparison Between Tailored Therapy Guided by a Non-invasive Antibiotic Susceptibility Test and Empiric Treatment for First-line Helicobacter Pylori Eradication in Patients With Dyspepsia: a Randomized Controlled Trial.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 362 (estimated)
• Sponsor: University of Bari · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of our study will be to assess in an open-label, multicenter, randomized controlled trial whether a tailored therapy guided by a non-invasive antibiotic susceptibility test on stool samples achieves higher Helicobacter eradication rates than an empiric antibiotic regimen. For this purpose, consecutive patients with dyspeptic symptoms, diagnosis of Helicobacter pylori infection and naïve to eradicating treatments will be allocated to either of the two intervention arms.

Detailed description

Study design: Eligible subjects will be defined by the positivity to at least 2 out of 4 tests for Helicobacter pylori infection diagnosis (i.e. histology, rapid urease test, urea breath test and serology). Stool samples and gastric biopsy specimens of eligible patients will be analyzed at enrollment, using real time-polymerase chain reaction (RT-PCR) to detect bacterial DNA mutations conferring resistance to amoxicillin, clarithromycin, tetracycline, metronidazole, and levofloxacin. Participants allocated to the tailored intervention arm will receive an antibiotic combination therapy according to the result of stool sample molecular analysis. Participants allocated to the empiric intervention arm will be treated by either a quadruple concomitant or bismuth-containing regimen, according to the 2017 European Helicobacter pylori management guidelines. In all participants, infection eradication will be evaluated 30 days after treatment end, using urea breath test. We will also assess the diagnostic accuracy of the RT-PCR on fecal samples in detecting bacterial antibiotic resistances, using the RT-PCR on gastric biopsy specimens as the reference standard.

Conditions

• Helicobacter Pylori Infection
• Antibiotic Resistant Infection
• Antibiotic Resistant Strain

Interventions

Type	Name	Description
DRUG	Pantoprazole 40mg	Proton pump inhibitor
DRUG	Amoxicillin 1000 MG	Antibiotic
DRUG	Clarithromycin 500mg	Antibiotic
DRUG	Metronidazole	Antibiotic
DRUG	Tetracycline 125 MG	Antibiotic
DRUG	Bismuth Subcitrate	Antibiotic adjuvant
DRUG	Rifabutin 150 MG	Antibiotic
DRUG	Levofloxacin 500mg	Antibiotic

Timeline

• Start date: 2020-01-14
• Primary completion: 2021-02-14
• Completion: 2022-04-14
• First posted: 2019-09-27
• Last updated: 2021-01-12

Locations

1 site across 1 country: Italy