Helicobacter Pylori Rescue Treatment Containing Tetracycline in Patients Allergic to Penicillin

Helicobacter Pylori Rescue Treatment Containing Tetracycline in Patients Allergic to Penicillin:a Prospective Randomized Controlled Study

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04264663

Enrollment

250

Registered

2020-02-11

Start date

2019-11-01

Completion date

2022-12-30

Last updated

2021-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

Allergic, Penicillin, Rescue Therapy, Tetracycline, Furazolidone

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.

Detailed description

Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies.However,Helicobacter pylori eradication is a challenge in patients allergic to penicillin. Therefore, the investigators aim 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.

Interventions

DRUGFurazolidone

Furazolidone-tetracycline-containing quadruple regimens

DRUGTinidazole

tinidazole-tetracycline-containing quadruple regimens

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Patients aged 18-70 with H. pylori infection. * Patients with previous Helicobacter pylori eradication. * Patients Allergic to Penicillin.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Eradication rates in 2 groups	12months	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.

Secondary

Measure	Time frame	Description
The rate of improving dyspepsia symptoms after Helicobacter pylori eradication	12months	The rate of improving dyspepsia symptoms after Helicobacter pylori eradication
The rate of adverse events happening	12months	Similarly, adverse events will also be measured by the Likert scale.
The rate of good compliance	12months	The rate of good compliance

Countries

China

Contacts

Primary ContactXiuli Zuo, MD,PhD

zuoxiuli@sina.com15588818685

Backup ContactXiuli Zuo, MD,PhD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026