NCT01725906

Brief Summary

We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs. empiric therapy in the third line therapy. Factors affecting the eradication rates, including the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2012

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

October 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

4.5 years

First QC Date

October 31, 2012

Last Update Submit

May 4, 2017

Conditions

Self Efficacy

Keywords

genotypic resistance guided therapy

Outcome Measures

Primary Outcomes (1)

  • Eradication rate after third line rescue therapy

    Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses. (genotypic resistance versus empirical therapy) Urea breath test will be used to determine the eradication status

    8 weeks

Secondary Outcomes (1)

  • eradication rates in subgroup analysis by antibiotic resistance and regimen

    8 weeks

Study Arms (2)

Empirical therapy

ACTIVE COMPARATOR

selection of antibiotic according to medication history

Drug: empirical therapy

Genotypic resistance guided therapy

EXPERIMENTAL

selection of antibiotics according to genotypic resistance

Drug: Genotypic resistance guided therapy

Interventions

empirical therapyDRUG

1. Nexium (esomeprazole), 40mg, bid, 14 days, plus 2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus 3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs 4. Select either one of the drugs according to medication history Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14

Also known as: selection of antibiotics according to medication history
Empirical therapy
Genotypic resistance guided therapyDRUG

1. Nexium (esomeprazole), 40mg, bid, 14 days, plus 2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus 3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs 4. Select either one of the drugs according to genotypic resistance results Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14

Also known as: selection of antibiotic according to genotypic resistance
Genotypic resistance guided therapy

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged greater than 20 years who have persistent H. pylori infection after at least two treatments and are willing to receive third line rescue regimens are considered eligible for enrollment.

You may not qualify if:

  • Patients will be excluded from the study if any one of the following criteria is present: (1) children and teenagers aged less than 20 years, (2) history of gastrectomy, (3)gastric malignancy, including adenocarcinoma and lymphoma, (4) previous allergic reaction to antibiotics (Amoxicillin, Klaricid, Cravit) and prompt pump inhibitors (esomeprazole), (5)contraindication to treatment drugs, (6) pregnant or lactating women, (7) severe concurrent disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan Universtiy Hospital

Taipei, Taiwan

RECRUITING

National Taiwan University Hospital, Yun-Lin Branch

Yun-Lin County, Taiwan

RECRUITING

Related Publications (1)

  • Liou JM, Chen PY, Luo JC, Lee JY, Chen CC, Fang YJ, Yang TH, Chang CY, Bair MJ, Chen MJ, Hsu YC, Hsu WF, Chang CC, Lin JT, Shun CT, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Efficacies of Genotypic Resistance-Guided vs Empirical Therapy for Refractory Helicobacter pylori Infection. Gastroenterology. 2018 Oct;155(4):1109-1119. doi: 10.1053/j.gastro.2018.06.047. Epub 2018 Jun 30.

    PMID: 29964036DERIVED

Study Officials

  • Jyh-Ming Liou

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jyh-Ming Liou, MD

CONTACT

+886223123456dtmed046@pchome.com.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 31, 2012

First Posted

November 14, 2012

Study Start

November 1, 2012

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations

TW(2)