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Trial record 21 of 214 for:    TETRACYCLINE

Levofloxacin Triple and Bismuth Quadruple Therapies for Rescue Treatment of H Pylori Infection

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ClinicalTrials.gov Identifier: NCT02978157
Recruitment Status : Completed
First Posted : November 30, 2016
Results First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.

Brief Summary:
From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: esomeprazole+amox+levo Drug: esomeprazole+bismuth+tetra+levo Not Applicable

Detailed Description:
The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either EAL (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) or EBTL (esomeprazole 40 mg b.d., bismuth 500 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.) therapy for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Levofloxacin-amoxicillin Triple Therapy vs. Levofloxacin-tetracycline Quadruple Therapy in Second-line Helicobacter Pylori Treatment
Study Start Date : February 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: esomeprazole+amox+levo
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.
Drug: esomeprazole+amox+levo
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.
Other Names:
  • esomeprazole 40 mg
  • amoxicillin 500 mg
  • levofloxacin 500 mg

Experimental: esomeprazole+bismuth+tetra+levo
esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
Drug: esomeprazole+bismuth+tetra+levo
esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
Other Names:
  • esomeprazole 40mg
  • bismuth 120 mg
  • tetracycline 500 mg
  • levofloxacin 500 mg




Primary Outcome Measures :
  1. Number of Participants in Which H. Pylori Was Eradicated [ Time Frame: six weeks after the end of anti-H pylori therapy. ]
    Number of participants with negative H pylori status in follow-up tests as a measure of successful eradication



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • positive results of both rapid urease test and histology,
  • a positive result of urea breath test,
  • or a positive result of culture.

Exclusion Criteria:

  • ingestion of antibiotics, bismuth, or proton pump inhibitor(PPI)within the prior 4 weeks,
  • patients with allergic history to the medications used,
  • patients with previous gastric surgery,
  • the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
  • pregnant women

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): NCT02978157


Locations
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Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Study Chair: Ping-I Hsu Kaohsiung Veterans General Hospital.
  Study Documents (Full-Text)

Documents provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:

Publications:

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Responsible Party: Ping-I (William) Hsu, M.D., Professor, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT02978157     History of Changes
Other Study ID Numbers: VGHKS104-062
First Posted: November 30, 2016    Key Record Dates
Results First Posted: March 14, 2019
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:
Helicobacter pylori
Eradication rate
Rescue treatment
Additional relevant MeSH terms:
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Tetracycline
Infection
Amoxicillin
Levofloxacin
Ofloxacin
Esomeprazole
Bismuth
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antacids
Protein Synthesis Inhibitors