Optimal Duration of Antimicrobial Susceptibility Test (AST) Guided Rescue Therapy for Helicobacter Pylori Infection

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Antimicrobial Susceptibility Test; Eradication; Helicobacter Pylori; Therapeutic Duration

Treatments: Other: 7-day triple regimen guided by AST; Other: 14-day triple regimen guided by AST; Other: 10-day triple regimen guided by AST

Study type: Interventional

Funder types: Other

Identifiers

NCT02934048

2016SDU-QILU-16

Details and patient eligibility

About

Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies. However, due to the increasing resistance rates to antibiotics, failures of H. pylori eradication get more and more common. Thus, rescue therapy for persistent H. pylori infection is becoming a grand challenge the investigators have to face.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients require upper endoscopy owing to persistent H. pylori infection despite one or more treatment attempts.

Exclusion criteria

• Age younger than 18 years;
• Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
• Known or suspected allergy to study medications;
• Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 3 patient groups

7-day triple regimen

Experimental group

Description:

Patients in this group received a 7-day triple regimen to eradicate H. pylori. The triple therapy contains proton pump inhibitor (PPI)-clarithromycin plus a susceptible antibiotics will be involved in the study.

Treatment:

Other: 7-day triple regimen guided by AST

10-day triple regimen

Experimental group

Description:

Patients in this group received a 10-day triple regimen to eradicate H. pylori. The triple therapy contains PPI-clarithromycin plus a susceptible antibiotics will be involved in the study.

Treatment:

Other: 10-day triple regimen guided by AST

14-day triple regimen

Experimental group

Description:

Patients in this group received a 14-day triple regimen to eradicate H. pylori. The triple therapy contains PPI-clarithromycin plus a susceptible antibiotics will be involved in the study.

Treatment:

Other: 14-day triple regimen guided by AST