Helicobacter Pylori First-line Treatment in Patients Allergic to Penicillin

Helicobacter Pylori First-line 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

NCT04122287

Enrollment

250

Registered

2019-10-10

Start date

2019-11-01

Completion date

2022-12-31

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, Helicobacter pylori, Eradication, Tetracycline

Brief summary

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

Interventions

DRUGLevofloxacin

levofloxacinn-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)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Patients with previous H. pylori eradication therapy. * Patients treated with Histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks. * Patients with gastrectomy, acute gastrointestinal bleeding and advanced gastric cancer. * Patients with known or suspected allergy to study medications. * Currently pregnant or lactating. * Inability to provide informed consent

Design outcomes

Primary

Measure	Time frame	Description
Eradication rates in 2 groups	24 months	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	24 months	Dyspepsia symptoms will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) before and after the Helicobacter pylori eradication.
The rate of adverse events happening	24 months	Similarly, adverse events will also be measured by the Likert scale.
The rate of good compliance	24 months	Patients taken over 90% of drugs are considered to have a good compliance.

Countries

China

Contacts

Primary ContactXiuli Zuo, PhD,MD

zuoxiuli@sina.com15588818685

Outcome results

None listed

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