Intravenous Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease

Intravenous Administration of Metronidazole, Levofloxacin and Esomeprazole Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04432233

Enrollment

Registered

2020-06-16

Start date

2020-06-15

Completion date

2021-06-15

Last updated

2020-08-27

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

Conditions

Helicobacter Pylori Infection, Intravenous Drug Usage

Keywords

Helicobacter Pylori Infection, Intravenous Drug Usage

Brief summary

Helicobacter pylori infection causes active peptic ulcer disease and related complications like bleeding and pyloric obstruction. Usually, clinicians tended to treat Helicobacter pylori infection after active peptic ulcer disease and related complicaitons getting healed, which spent time and money. This study is designed to evaluate the efficacy and safety of intravenous administration of metronidazole, levofloxacin and esomeprazole triple therapy in the treatment of Helicobacter pylori infection combined with peptic ulcer disease related complications.

Interventions

DRUGEsomeprazole

Proton pump inhibitor

DRUGMetronidazole

antibiotic for H. pylori eradication

DRUGLevofloxacin

antibiotic for H. pylori eradication

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Male or female aged between 18 and 75 years old * Without previous Helicobacter pylori treatment * Diagnosed with active peptic ulcer disease and related complications like bleeding and pyloric obstruction by endoscopy examination * Ability and willingness to participate in the study and to sign and give informed consent * Positive for Helicobacter pylori IgM antibody

Exclusion criteria

* With previous gastric surgery * Major systemic diseases * Pregnancy or lactation * Allergy to any of the study drugs * Decline to participate in the study

Design outcomes

Primary

Measure	Time frame	Description
Helicobacter pylori eradication rate	Six weeks after completion of therapy	Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).

Secondary

Measure	Time frame
Rate of adverse effects	Within 7 days after completion of therapy
Rate of stop bleeding	Within 7 days after completion of therapy
Rate of pyloric obstruction remission	Within 7 days after completion of therapy

Countries

China

Contacts

Primary ContactXiao Liang, PHD,MD

xliang5515@gmail.com13120839615

Outcome results

None listed

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