Helicobacter Pylori First-line Treatment in Patients Allergic to Penicillin

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Levofloxacin; Drug: tinidazole

Study type: Interventional

Funder types: Other

Identifiers

NCT04122287

2019-SDU-QILU-G709

Details and patient eligibility

About

The purpose of this study is to assess and compare the effectiveness of levofloxacin-tetracycline -containing and tinidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

Full description

Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies.However,Helicobacter pylori eradication is a challenge in patients allergic to penicillin.

Therefore, the investigators aim to assess and compare the effectiveness of levofloxacin-tetracycline -containing and tinidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18-70 with H. pylori infection.
• Patients Allergic to Penicillin.

Exclusion criteria

• Patients with previous H. pylori eradication therapy.
• Patients treated with Histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks.
• Patients with gastrectomy, acute gastrointestinal bleeding and advanced gastric cancer.
• Patients with known or suspected allergy to study medications.
• Currently pregnant or lactating.
• Inability to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups

levofloxacin-tetracycline-containing quadruple group

Experimental group

Description:

patients in levofloxacin-tetracycline-containing quadruple group will receive lansoprazole 30mg po bid, tetracycline 500mg po qid , bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and levofloxacin 500mg po qd for 14d

Treatment:

Drug: Levofloxacin

tinidazole-tetracycline-containing quadruple group

Active Comparator group

Description:

patients in tinidazole-tetracycline-containing quadruple group will receive lansoprazole 30mg po bid, tetracycline 500mg po qid , bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and tinidazole 500mg po tid for 14d.

Treatment:

Drug: tinidazole