Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

Yanqing Li

Status and phase: Unknown; Phase 4

Conditions: Triple Therapy; Antimicrobial Susceptibility Testing

Treatments: Drug: tetracycline; Drug: furazolidone; Drug: clarithromycin; Drug: amoxicillin; Drug: Ilaprazole; Drug: levofloxacin; Drug: tinidazole

Study type: Interventional

Funder types: Other

Identifiers

NCT03139253

2017SDU-QILU-02

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consecutive patients who are 18-70 years old with persistent H. pylori infection after first or second line treatment attempts.

Exclusion criteria

• Enable to undergo upper endoscopy;
• Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
• Known or suspected allergy to study medications;
• Taking bismuth and antibiotics in the previous four weeks, or taking proton pump inhibitor and H2-receptor blockers in the previous two weeks;
• Currently pregnant or lactating
• Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 5 patient groups

clarithromycin susceptible

Experimental group

Description:

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI).

Treatment:

Drug: clarithromycin

Drug: Ilaprazole

Drug: amoxicillin

metronidazole susceptible

Experimental group

Description:

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tinidazole.

Treatment:

Drug: Ilaprazole

Drug: amoxicillin

Drug: tinidazole

levofloxacin susceptible

Experimental group

Description:

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and levofloxacin.

Treatment:

Drug: Ilaprazole

Drug: amoxicillin

Drug: levofloxacin

furazolidone susceptible

Experimental group

Description:

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and furazolidone.

Treatment:

Drug: Ilaprazole

Drug: amoxicillin

Drug: furazolidone

tetracycline susceptible

Experimental group

Description:

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tetracycline.

Treatment:

Drug: Ilaprazole

Drug: amoxicillin

Drug: tetracycline