Antibiotic Combination for H. Pylori Eradication in Penicillin-allergic Patients

Helicobacter Pylori Infection Clinical Trial

Official title:

Clarithromycin-, Metronidazole-, or Levofloxacin-containing Therapy for Helicobacter Pylori-infected Penicillin-allergic Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05023577
• Other study ID #: B2021-3762
• Status: Recruiting
• Phase: Phase 4
• Start date: August 26, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Qi Chen, MD
• Phone: 86-17811921405
• Email: chenqimd[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled clinical trial will compare the eradication efficacy of bismuth quadruple therapy containing clarithromycin+metronidazole, clarithromycin+levofloxacin, or metronidazole+levofloxacin for Helicobacter pylori first-line treatment in penicillin-allergic patients. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 504
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).

• 18-75 years old on the day of signing the ICF.

• Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.

• Have not received Helicobacter pylori eradication treatment before.

• allergic to penicillin.

Exclusion Criteria:

• Have received Hp eradication treatment.

• Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.

• Subjects or guardians refused to participate in the trial.

• Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.

• Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment.

• Pregnant or lactating women.

• Active peptic ulcer.

• allergic to drugs used in the trial.

• any other circumstances that are not suitable for recruitment.

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Rabeprazole
20mg bid
• Bismuth potassium citrate
0.6g bid
• Metronidazole
0.4g qid
• Clarithromycin
0.5g bid
• Levofloxacin
0.5g qd

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence rate	Adherence was defined as poor when subjects took less than 80% of the total medication.	2 weeks during therapy
Other	Frequency of adverse events	Any possible adverse events during the 14-day treatment period were recorded.	2 weeks during therapy
Primary	Eradication rate of Helicobacter pylori	Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value).	At least 4 weeks after completion of therapy
Secondary	Eradication rate of Helicobacter pylori resistant strains	Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method.	At least 4 weeks after completion of therapy
Secondary	Eradication rate of Helicobacter pylori susceptible strains	Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method.	At least 4 weeks after completion of therapy