Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin

NCT06351891 | Not Yet Recruiting Phase 4

• 1 other identifier: SHARE2402
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomly assigned to receive either 14 days of bismuth quadruple therapy with cefuroxime and tetracycline or 14 days of bismuth quadruple therapy with cefuroxime and levofloxacin for Helicobacter pylori eradication. After 6 weeks of treatment, subjects underwent another 13C urea breath test. Eradication rates, adverse reaction rates and patient compliance were calculated.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori Infection; Bismuth-containing quadruple therapy

Outcome Measures

Primary Outcomes (1)

• Eradication rate

  Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups.

  immediately after the procedure

Secondary Outcomes (2)

• Rate of adverse reactions

  immediately after the procedure

• Patient compliance

  immediately after the procedure

Study Arms (2)

14-day bismuth quadruple regimen containing cefuroxime and tetracycline

EXPERIMENTAL

14-day bismuth quadruple regimen containing cefuroxime and tetracycline:Tegoprazan (50mg twice/day before breakfast and supper), Bismuth potassium citrate capsule (0.6g twice/day before breakfast and supper), Cefuroxime tablets (500mg twice/day after breakfast and supper), Tetracycline (500mg three times/day after three meals);14 days.

Drug: 14-day bismuth quadruple regimen containing cefuroxime and tetracycline

14-day bismuth quadruple regimen containing cefuroxime and levofloxacin

ACTIVE COMPARATOR

14-day bismuth quadruple regimen containing cefuroxime and levofloxacin:Tegoprazan (50mg twice/day before breakfast and supper), Bismuth potassium citrate capsule (0.6g twice/day before breakfast and supper), Cefuroxime tablets (500mg twice/day after breakfast and supper), Levofloxacin (500mg once/day after breakfast);14 days.

Drug: 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin

Interventions

14-day bismuth quadruple regimen containing cefuroxime and tetracycline DRUG

14-day bismuth quadruple regimen containing cefuroxime and tetracycline:Tegoprazan 50mg bid, Bismuth potassium citrate capsules 0.6g bid,Cefuroxime tablets 500mg bid,Tetracycline 500mg tid,14 days.Evaluating the efficacy and safety of 14-Day bismuth quadruple therapy containing cefuroxime and tetracycline for Helicobacter pylori eradication.

14-day bismuth quadruple regimen containing cefuroxime and tetracycline

14-day bismuth quadruple regimen containing cefuroxime and levofloxacin DRUG

14-day bismuth quadruple regimen containing cefuroxime and levofloxacin:Tegoprazan 50mg bid, Bismuth potassium citrate capsules 0.6g bid,Cefuroxime tablets 500mg bid,Levofloxacin 500mg qd,14 days.

14-day bismuth quadruple regimen containing cefuroxime and levofloxacin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years old, regardless of gender.
• History of penicillin allergy.
• Helicobacter pylori infection.
• Patients who have not previously received Helicobacter pylori eradication therapy.

You may not qualify if:

• Medication history of bismuth and antibiotics within 4 weeks; PPIs and P-CABs within 2 weeks.
• Serious underlying diseases, such as liver insufficiency, renal insufficiency, malignant tumors, etc.
• Previous gastric or esophageal surgery.
• History of allergy to test drugs.
• Pregnant and lactating women and those unwilling to use contraception during the trial period.
• Have other behaviors that may increase the risk such as alcohol and drug abuse.
• Those unable to provide informed consent.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (1)

• Wang H, Kong Q, Zhang Q, Zhang L, Li R, Zhang T, Guo L, Wang X, Li X, Zhao H, Liu F, Guo Y, Zhai Z, Li M, Yang X, Zuo X, Yang X, Li Y. Efficacy and Safety of Cefuroxime-Tetracycline-Containing Bismuth Quadruple Therapy for Helicobacter pylori Eradication in Penicillin-Allergic Patients: A Multicenter Randomized Controlled Trial. Helicobacter. 2025 Mar-Apr;30(2):e70033. doi: 10.1111/hel.70033.

  PMID: 40237213 DERIVED

MeSH Terms

Interventions

Tetracycline; Levofloxacin

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yueyue Li, MD,PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueyue Li, MD,PhD

CONTACT

86-18560089751; lyynqj@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-02

Locations

CN (1)