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

Phase 4

• Conditions: Intravenous Drug Usage; Helicobacter Pylori Infection
• Interventions: Drug: Esomeprazole; Drug: Metronidazole; Drug: Levofloxacin

• Registration Number: NCT04432233
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-12
• Study Start: 2020-06-15
• Study First Posted: 2020-06-16
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-25
• Last Update Posted: 2020-08-27
• Primary Completion: 2021-04-15
• Study Completion: 2021-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravenous therapy	Esomeprazole	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.
Intravenous therapy	Levofloxacin	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.
Intravenous therapy	Metronidazole	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China