NCT03726099

Brief Summary

The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.

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
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

October 29, 2018

Last Update Submit

February 19, 2020

Conditions

Helicobacter Pylori Infection

Keywords

Concomitant TherapyRescue treatment

Outcome Measures

Primary Outcomes (1)

  • Eradication rates

    Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all the patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.

    6 months

Secondary Outcomes (3)

  • The rate of adverse events happening

    6 months

  • Changes of dyspepsia symptoms after Helicobacter pylori eradication

    6 months

  • The rate of good compliance

    6 months

Study Arms (1)

14d concomitant therapy

EXPERIMENTAL

Patients will receive a 14-day concomitant therapy containing esomeprazole, amoxicillin, tetracycline and furazolidone.

Drug: esomeprazole, amoxicillin, furazolidone，tetracycline

Interventions

esomeprazole, amoxicillin, furazolidone，tetracyclineDRUG

Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day concomitant therapy containing esomeprazole 40mg bid, amoxicillin 1000mg bid , furazolidone 100mg bid and tetracycline 500mg qid.

14d concomitant therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-70 with persistent H. pylori infection.
  • Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.

You may not qualify if:

  • Patients unable or unwilling to receive gastroscopy.
  • Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
  • Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.
  • History of allergy to any of the drugs used in the study.
  • Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.
  • Currently pregnant or lactating.
  • Severe neurologic or psychiatric disorders.
  • Alcohol abuse or drug addiction.
  • Patients with compliance lower than 90% in any previous treatment are not included.
  • Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiuli Zuo

Jinan, Shandong, China

RECRUITING

MeSH Terms

Interventions

EsomeprazoleAmoxicillin

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmides

Study Officials

  • Xiuli Zuo, MD,PhD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, MD,PhD

CONTACT

8653182169025qlywc@163.com

Xiuli Zuo, MD，PhD

CONTACT

8653182169025qlywc@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of Qilu Hospital gastroenterology department

Study Record Dates

First Submitted

October 29, 2018

First Posted

October 31, 2018

Study Start

March 15, 2019

Primary Completion

April 30, 2020

Study Completion

December 30, 2020

Last Updated

February 21, 2020

Record last verified: 2020-02

Locations

CN(1)