NCT04090021

Genotypic Resistance-guided Versus Empirical Therapy for H. Pylori Eradication.

Genotypic Resistance-guided Triple Therapy Versus Empirical Concomitant Therapy for First-line H. Pylori Eradication.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: Konstantopoulio-Patission General Hospital of Nea Ionia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the efficacy of a 7-day genotypic resistance-guided triple therapy, compared with empirical concomitant therapy, for first-line eradication of H. pylori.

Detailed description

Empiric eradication of H. pylori becomes steadily more challenging because of increasing antibiotic resistance. In high-resistance countries where bismuth and/or tetracycline are unavailable (eg; Greece), non-bismuth quadruple therapies are currently recommended as first-line therapeutic options; however, eradication rates \>95% are infrequently achieved and even \>90% are disputed. Antimicrobial susceptibility-guided therapy is a promising alternative in order to maintain high therapeutic efficacy. However, traditional culture-based susceptibility testing methods have several shortcomings, including they are time-consuming and they do not 100% reflect in vivo eradication. Recent guidelines also recommend the use of molecular testing for evaluation of H. pylori antibiotic susceptibility. Nevertheless, the efficacy of genotypic resistance-guided treatment of H. pylori has been seldom appraised. Therefore, the investigators conducted this prospective randomized controlled trial aiming to investigate the efficacy of a 7-day genotypic resistance-guided triple therapy, compared with empirical concomitant therapy, for first-line eradication of H. pylori.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Esomeprazole 40mg	Use in a drug combination for H. pylori eradication
DRUG	Clarithromycin 500mg	Use in a drug combination for H. pylori eradication
DRUG	Metronidazole 500 mg	Use in a drug combination for H. pylori eradication
DRUG	Amoxicillin 1000 MG	Use in a drug combination for H. pylori eradication
DRUG	Levofloxacin 500mg	Use in a drug combination for H. pylori eradication
DRUG	Rifabutin 150 MG	Use in a drug combination for H. pylori eradication

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2019-09-16
• Last updated: 2019-09-19

Locations

1 site across 1 country: Greece