NCT04264663

Brief Summary

The purpose of this study is to assess and compare the effectiveness of furazolidone-tetracycline-containing and tinidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection in patients allergic to penicillin.

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
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2019

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

3 years

First QC Date

February 8, 2020

Last Update Submit

November 17, 2021

Conditions

Helicobacter Pylori Infection

Keywords

AllergicPenicillinRescue TherapyTetracyclineFurazolidone

Outcome Measures

Primary Outcomes (1)

  • Eradication rates in 2 groups

    Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned 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.

    12months

Secondary Outcomes (3)

  • The rate of improving dyspepsia symptoms after Helicobacter pylori eradication

    12months

  • The rate of adverse events happening

    12months

  • The rate of good compliance

    12months

Study Arms (2)

furazolidone-tetracycline-containing quadruple

EXPERIMENTAL

patients in furazolidone-tetracycline-containing quadruple group will receive Esomeprazole 40mg po bid, tetracycline 500mg po qid , bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and furazolidone 100mg po bid for 14d

Drug: Furazolidone

tinidazole-tetracycline-containing quadruple group

ACTIVE COMPARATOR

patients in tinidazole-tetracycline-containing quadruple group will receive Esomeprazole 40mg po bid, tetracycline 500mg po qid , bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and tinidazole 500mg po tid for 14d.

Drug: Tinidazole

Interventions

FurazolidoneDRUG

Furazolidone-tetracycline-containing quadruple regimens

furazolidone-tetracycline-containing quadruple
TinidazoleDRUG

tinidazole-tetracycline-containing quadruple regimens

tinidazole-tetracycline-containing quadruple group

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 H. pylori infection.
  • Patients with previous Helicobacter pylori eradication.
  • Patients Allergic to Penicillin.

You may not qualify if:

  • Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
  • Patients with gastrectomy, acute GI bleeding and advanced gastric cancer.
  • Patients with known or suspected allergy to study medications.
  • Currently pregnant or lactating.
  • 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)

Qilu hospital

Jinan, Shandong, 250000, China

RECRUITING

MeSH Terms

Interventions

FurazolidoneTinidazole

Intervention Hierarchy (Ancestors)

NitrofuransNitro CompoundsOrganic ChemicalsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFuransNitroimidazolesImidazoles

Study Officials

  • Xiuli Zuo, MD,PhD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, MD,PhD

CONTACT

15588818685zuoxiuli@sina.com

Xiuli Zuo, MD,PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of Qilu Hospital gastroenterology department

Study Record Dates

First Submitted

February 8, 2020

First Posted

February 11, 2020

Study Start

November 1, 2019

Primary Completion

October 30, 2022

Study Completion

December 30, 2022

Last Updated

November 18, 2021

Record last verified: 2021-11

Locations

CN(1)