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

S

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)

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

Trial contacts and locations

0

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Central trial contact

Li Yanqing, MD, PhD

Data sourced from clinicaltrials.gov

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