Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

304

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Sep 2019

Shorter than P25 for phase_4

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6 months study duration

Study Start

First participant enrolled

September 1, 2019

Completed

11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2019

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2019

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed

Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

September 12, 2019

Last Update Submit

September 17, 2019

Conditions

Helicobacter Pylori Infection

Keywords

H. pylorigenotypic resistancetailored therapyconcomitant therapy

Outcome Measures

Primary Outcomes (1)

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 Outcomes (2)

Rate of adverse effects
At least 6 weeks after treatment completion
Compliance rates
At least 6 weeks after treatment completion

Study Arms (2)

Genotypic resistance-guided triple therapy

EXPERIMENTAL

In the group of genotypic resistance-guided triple therapy, a molecular assay based on DNA-strip technology was used to determine the genotypic resistance of H. Pylori to clarithromycin (23SrRNA mutations) and fluoroquinolones (gyrA mutations) from gastric biopsy specimens. According to 23SrRNA and gyrA mutational analyses, a 7-day tailored triple therapy therapy was given as follows: Wild-type 23SrRNA: Clarithromycin-based triple therapy comprising esomeprazole 40 mg b.i.d., amoxicillin 1 g b.i.d. and clarithromycin 500 mg b.i.d. 23SrRNA mutated/wild-type gyrA: Levofloxacin-based triple therapy comprising esomeprazole 40 mg b.i.d., amoxicillin 1 g b.i.d. and levofloxacin 500 mg b.i.d. 23SrRNA mutated/gyrA mutated: Rifabutin-based triple therapy comprising esomeprazole 40 mg b.i.d., amoxicillin 1 g t.i.d. and rifabutin 150 mg b.i.d.

Drug: Esomeprazole 40mgDrug: Clarithromycin 500mgDrug: Amoxicillin 1000 MGDrug: Levofloxacin 500mgDrug: Rifabutin 150 MG

Empirical concomitant therapy

ACTIVE COMPARATOR

In the empirical concomitant group, patients received esomeprazole 40mg, amoxicillin 1gr, clarithromycin 500mg and metronidazole 500mg, all b.i.d., for 10-14 days.

Drug: Esomeprazole 40mgDrug: Clarithromycin 500mgDrug: Metronidazole 500 mgDrug: Amoxicillin 1000 MG