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

NCT04432233 | Unknown Phase 4 DMC

• 1 other identifier: rjkls2020031
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection; Intravenous Drug Usage

Keywords

Helicobacter Pylori Infection; Intravenous Drug Usage

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

  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).

  Six weeks after completion of therapy

Secondary Outcomes (3)

• 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

Study Arms (1)

Intravenous therapy

EXPERIMENTAL

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.

Drug: Esomeprazole; Drug: Metronidazole; Drug: Levofloxacin

Interventions

Esomeprazole DRUG

Proton pump inhibitor

Intravenous therapy

Metronidazole DRUG

antibiotic for H. pylori eradication

Intravenous therapy

Levofloxacin DRUG

antibiotic for H. pylori eradication

Intravenous therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Interventions

Esomeprazole; Metronidazole; Levofloxacin

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Hong Lu, PHD,MD

  Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Liang, PHD,MD

CONTACT

13120839615; xliang5515@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: June 15, 2020
• Primary Completion: April 15, 2021
• Study Completion: June 15, 2021
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)