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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04432233
• Other study ID #: rjkls2020031
• Status: Recruiting
• Phase: Phase 4
• Start date: June 15, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: August 2020
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Xiao Liang, PHD,MD
• Phone: 13120839615
• Email: xliang5515[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection
• Intravenous Drug Usage
• Peptic Ulcer

Intervention

Drug:
• Esomeprazole
Proton pump inhibitor
• Metronidazole
antibiotic for H. pylori eradication
• Levofloxacin
antibiotic for H. pylori eradication

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of adverse effects		Within 7 days after completion of therapy
Secondary	Rate of stop bleeding		Within 7 days after completion of therapy
Secondary	Rate of pyloric obstruction remission		Within 7 days after completion of therapy