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

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Infection; Intravenous Drug Usage

Treatments: Drug: Esomeprazole; Drug: Metronidazole; Drug: Levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT04432233

rjkls2020031

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Intravenous therapy

Experimental group

Description:

Subjected enrolled will receive (a) a 10-day intravenous triple therapy containing esomeprazole 40 mg thrice a day, metronidazole 500 mg twice a day and levofloxacin 500 mg once a day and (b) esomeprazole 20 mg twice a day taken orally for 8 weeks.

Treatment:

Drug: Metronidazole

Drug: Levofloxacin

Drug: Esomeprazole