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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04090021
• Other study ID #: 10548
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: September 2019
• Source: Konstantopoulio-Patission General Hospital of Nea Ionia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive outpatients aged =18 years with documented H. pylori infection. Mental and legal ability to provide written informed consent.

Exclusion Criteria:

• previous history of H. pylori eradication therapy

• history of allergies to the medications used

• previous esophageal or gastric surgery

• serious systemic disease

• pregnancy or lactation.

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Esomeprazole 40mg
Use in a drug combination for H. pylori eradication
• Clarithromycin 500mg
Use in a drug combination for H. pylori eradication
• Metronidazole 500 mg
Use in a drug combination for H. pylori eradication
• Amoxicillin 1000 MG
Use in a drug combination for H. pylori eradication
• Levofloxacin 500mg
Use in a drug combination for H. pylori eradication
• Rifabutin 150 MG
Use in a drug combination for H. pylori eradication

Locations

Country	Name	City	State
Greece	Konstantopoulio-Patision General Hospital	Athens	Nea Ionia

Sponsors (1)

Lead Sponsor	Collaborator
Konstantopoulio-Patission General Hospital of Nea Ionia

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of H. pylori eradication	Rate of H. pylori eradication by intention to treat/per protocol in each group at least 6 weeks after treatment completion using the urea breath test.	At least 6 weeks after treatment completion
Secondary	Rate of adverse effects	Adverse events were investigated by means of a structured clinical interview immediately after the completion of therapy. The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities).	At least 6 weeks after treatment completion
Secondary	Compliance rates	Drug compliance was determined by counting unused medication. For this purpose, any tablet that was not consumed was brought back to the clinic for pill count. Poor compliance was defined as taking less than 80% of the total medication prescribed.	At least 6 weeks after treatment completion