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Trial record 24 of 605 for:    Anti-Infective Agents AND susceptibility

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

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ClinicalTrials.gov Identifier: NCT02934048
Recruitment Status : Unknown
Verified October 2016 by Yanqing Li, Shandong University.
Recruitment status was:  Not yet recruiting
First Posted : October 14, 2016
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Therapeutic Duration Helicobacter Pylori Antimicrobial Susceptibility Test Eradication Other: 7-day triple regimen guided by AST Other: 10-day triple regimen guided by AST Other: 14-day triple regimen guided by AST Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: 7-day triple regimen
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.
Other: 7-day triple regimen guided by AST
Patients in this group will receive a 7-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.

Experimental: 10-day triple regimen
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.
Other: 10-day triple regimen guided by AST
Patients in this group will receive a 10-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.

Experimental: 14-day triple regimen
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.
Other: 14-day triple regimen guided by AST
Patients in this group will receive a 14-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.




Primary Outcome Measures :
  1. The different rate of H. pylori eradication among 3 different course of treatments (7-day, 10-day and 14-day) guided by AST in intention-to-treat (ITT) analysis. [ Time Frame: 9 months ]
  2. The different rate of H. pylori eradication among 3 different course of treatments (7-day, 10-day and 14-day) guided by AST in per-protocol (PP) analysis. [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. the rate of improving dyspepsia symptoms after H. pylori eradication [ Time Frame: 9 months ]
  2. the rate of adverse events happening [ Time Frame: 9 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934048


Contacts
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Contact: Li Yanqing, MD, PhD 86-531-82169236 liyanqing@sdu.edu.cn

Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Li Yanqing, MD, PhD Qilu Hospital of Shandong University

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Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT02934048     History of Changes
Other Study ID Numbers: 2016SDU-QILU-16
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Disease Susceptibility
Anti-Bacterial Agents
Anti-Infective Agents
Antitubercular Agents
Disease Attributes
Pathologic Processes
Clarithromycin
Antibiotics, Antitubercular
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors