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Trial record 85 of 214 for:    TETRACYCLINE

Comparison of the Levofloxacin Sequential Therapy and Quadruple Therapy in Second Line Treatment for HP

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ClinicalTrials.gov Identifier: NCT03148366
Recruitment Status : Unknown
Verified March 2017 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : May 11, 2017
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

Objectives: Eradication of H. pylori infection could reduce the occurence or recurrence of gastric cancer and peptic ulcer diseases. However, it was estimated that 15-20% of patients would fail from first line standard eradication therapy and need second line rescue therapy. About 15-30% of patient would fail from second line therapy. Bismuth quadruple therapy and triple therapy containing levofloxacin are currently the recommended rescue therapies in the second line and third line treatment. Recently, our pilot study showed that modified sequential therapy containing levofloxacin achieved high eradication rate (95%) in the second line therapy. The regimen includes a PPI plus amoxicillin for 5-7 days, followed by a PPI plus levofloxacin and metronidazole for another 5-7 days. However, whether this modified sequential therapy containing levofloxacin is more effective than bismuth quadruple therapy in the second line and third line treatment remains unknown. Besides, the impact of these regimens on the antibiotic resistance , microbiota of gut flora, and metabolic factors remains unknown.

Aims: Therefore, the investigators aimed to

  1. compare the eradication rates and long term re-infection rates of sequential therapy containing levofloxacin for 14 days versus bismuth quadruple therapy for 10 days in the second line and third line treatment
  2. assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of these regimens
  3. assess the impact of these eradication regimens on the antibiotic resistance and microbiota of the gut flora
  4. assess the impact of eradication therapy on the metabolic factors

Condition or disease Intervention/treatment Phase
Helicobacter Drug: Levofloxacin based sequential therapy Drug: bismuth quadruple therapy for 10 days (BQ) Phase 3

Detailed Description:

Methods:

This will be a multi-center, open labeled, randomized comparative trial with cross-over design Patients: Participants with refractory H. pylori infection after one eradication therapy

Testing for H. pylori infection Before Second Line Treatment : Any two positive of CLO test, histology, and culture or a positive UBT will be considered as H. pylori infected

After Second Line Treatment: C13-UBT will be used to assess the existence of H. pylori 6-8 weeks after first line therapy.

Long term reinfection: C13-UBT will be used to assess the recurrence of H. pylori 1 year after eradication therapy

Interventions:

Second line therapy: eligible patients will be randomized into one of the two groups Group (A): sequential therapy containing levofloxacin for 14 days (EAML) D1-D7: (esomeprazole 40mg bid + amoxicillin 1gm bid) for 7 days D8-D14: (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid) for another 7 days

Group (B): bismuth quadruple therapy for 10 days (BQ) D1-D10: (esomeprazole 40mg bid + Dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days

Third line therapy: patients who fail from second line treatment will be rescue with the following treatment Group (A) Patient who fail from levofloxacin sequential therapy will be retreated with bismuth quadruple therapy for 10 days D1-D10: (esomeprazole 40mg bid + Dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days

Group (B) Patient who fail from bismuth quadruple therapy will be retreated with levofloxacin sequential therapy for 14days D1-D7: (esomeprazole 40mg bid + amoxicillin 1gm bid) for 7 days D8-D14: (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid) for another 7 days

Outcome Measurement:

Primary End Point: Eradication rate in the second line according to intention to treat (ITT) and per-protocol (PP) analysis in the two treatment groups


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Bismuth Quadruple Therapy in the Second Line and Third Line Therapy for Helicobacter Pylori Infection- A Multi-center Randomized Trial
Study Start Date : February 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levofloxacin based sequential therapy

Levofloxacin based sequential therapy

: sequential therapy containing levofloxacin for 14 days D1-D7: (esomeprazole 40mg bid + amoxicillin 1gm bid) for 7 days D8-D14: (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid) for another 7 days

Drug: Levofloxacin based sequential therapy
D1-D7: (esomeprazole 40mg bid + amoxicillin 1gm bid) for 7 days D8-D14: (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid) for another 7 days

Active Comparator: bismuth quadruple therapy (BQ)
bismuth quadruple therapy for 10 days (BQ) D1-D10: (esomeprazole 40mg bid + Dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days
Drug: bismuth quadruple therapy for 10 days (BQ)
D1-D10: (esomeprazole 40mg bid + Dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days




Primary Outcome Measures :
  1. Eradication rate after second line eradication therapy according to ITT analysis [ Time Frame: 6 weeks after completion of treatment ]
    The eradication status will be determined by urea breath test (UBT) at least 6 weeks after completion of the treatment. The delta value of UBT of 4 or less will be defined as negative and successful eradication.


Secondary Outcome Measures :
  1. Adverse effects during eradication therapy [ Time Frame: during treatment (2 weeks) ]
    adverse effects will be assessed by questionnaire

  2. Long term eradication rate 1 year after eradication therapy [ Time Frame: 1 year after treatment ]
    Long term eradication rates will be determined by UBT at 1 year after eradication therapy.

  3. changes of gut microbiota before and after eradication therapy [ Time Frame: 1 year ]
    Fecal DNA will be extracted and 16S rRNA sequencing will be done. The changes in the alpha and beta diversity and the compositions of gut microbiota before and after HP eradication will be assessed.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1. H. pylori infected patients who failed from first line standard triple therapy with clarithromycin, amoxicillin, and a proton pump inhibitor were eligible in this study

Exclusion Criteria:

  1. children and teenagers aged less than 20 years,
  2. history of gastrectomy,
  3. gastric malignancy, including adenocarcinoma and lymphoma,
  4. previous allergic reaction to antibiotics (bismuth, metronidazole, levofloxacin, tetracycline) and PPI (esomeprazole),
  5. contraindication to treatment drugs,
  6. pregnant or lactating women,
  7. severe concurrent disease, or
  8. Unwilling to accept random assignment of subjects

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): NCT03148366


Contacts
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Contact: Jyh-Ming Liou, MD, PhD dtmed046@pchome.com.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Ming-Shiang Wu         
Contact: Jyh-Ming Liou         
Sub-Investigator: Chieh-Chang Chang         
Sub-Investigator: Jyh-MIng Liou         
National Taiwan University Hospital, Yunlin branch Recruiting
Yunlin, Taiwan
Contact: Yu-Jen Fang         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: Ming-Shiang Wu National Taiwan University Hospital
Principal Investigator: Jyh-Ming Liou National Taiwan University Hospital

Publications of Results:
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03148366     History of Changes
Other Study ID Numbers: 201410001MINC
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators will not share the data.
Keywords provided by National Taiwan University Hospital:
Self Efficacy
Additional relevant MeSH terms:
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Metronidazole
Levofloxacin
Ofloxacin
Esomeprazole
Bismuth
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic 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